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Trial record 2 of 27 for:    keto

An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

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ClinicalTrials.gov Identifier: NCT04195594
Recruitment Status : Completed
First Posted : December 12, 2019
Results First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
TRC GEN+ managed by Trans Russian co Cy

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Ketogenic Dieting
Healthy
Intervention Other: Nic's Keto Diet
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
39.86  (7.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Eastern European White
4
  28.6%
South American
3
  21.4%
South Asian
1
   7.1%
Western European White
6
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 14 participants
14
1.Primary Outcome
Title Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
Hide Description The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percentage of body fat
-2.25  (2.48)
2.Primary Outcome
Title Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
Hide Description The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percentage of muscle mass
2.24  (2.49)
3.Primary Outcome
Title Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
Hide Description The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percentage of body fat
-4.41  (4.04)
4.Primary Outcome
Title Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
Hide Description The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percentage of muscle mass
4.38  (4.03)
5.Primary Outcome
Title Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet
Hide Description Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-1.64  (0.83)
6.Primary Outcome
Title Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to weight as assessed by BMI was reported at baseline and compared to day 140.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-2.82  (1.49)
7.Secondary Outcome
Title The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days
Hide Description The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm/hr
0.36  (4.43)
8.Secondary Outcome
Title The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days
Hide Description The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mg/L
-0.71  (2.10)
9.Secondary Outcome
Title Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: kg
-3.02  (2.09)
10.Secondary Outcome
Title Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: kg
-4.47  (2.79)
11.Secondary Outcome
Title Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: kg
-5.58  (3.07)
12.Secondary Outcome
Title Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: kg
-6.43  (3.93)
13.Secondary Outcome
Title Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mm Hg
1.23  (7.79)
14.Secondary Outcome
Title Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mm Hg
-3.06  (6.62)
15.Secondary Outcome
Title Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2.73  (8.30)
16.Secondary Outcome
Title Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm Hg
-3.85  (7.58)
17.Secondary Outcome
Title Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm Hg
-6.52  (9.53)
18.Secondary Outcome
Title Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L)
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.87  (1.01)
19.Secondary Outcome
Title Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.04  (0.62)
20.Secondary Outcome
Title Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.04  (0.27)
21.Secondary Outcome
Title Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.89  (0.84)
22.Secondary Outcome
Title Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.91  (0.97)
23.Secondary Outcome
Title Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.07  (0.67)
24.Secondary Outcome
Title Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.01  (0.28)
25.Secondary Outcome
Title Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.93  (0.87)
26.Secondary Outcome
Title Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.13  (1.21)
27.Secondary Outcome
Title Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.11  (0.57)
28.Secondary Outcome
Title Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.02  (0.32)
29.Secondary Outcome
Title Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.16  (1.12)
30.Secondary Outcome
Title Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.01  (1.31)
31.Secondary Outcome
Title Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.16  (0.55)
32.Secondary Outcome
Title Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.10  (0.38)
33.Secondary Outcome
Title Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.99  (1.17)
34.Secondary Outcome
Title Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.06  (1.10)
35.Secondary Outcome
Title Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.23  (0.41)
36.Secondary Outcome
Title Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.15  (0.27)
37.Secondary Outcome
Title Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.02  (0.94)
38.Secondary Outcome
Title Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent of Glycosylated Haemoglobin
-0.22  (0.18)
39.Secondary Outcome
Title Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.06  (0.37)
40.Secondary Outcome
Title Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: pmol/L
-0.85  (0.55)
41.Secondary Outcome
Title Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet
Hide Description Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: kg
-4.90  (2.66)
42.Secondary Outcome
Title Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: kg
-8.55  (4.74)
43.Secondary Outcome
Title Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Hide Description Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mm Hg
-3.72  (7.96)
44.Secondary Outcome
Title Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Hide Description Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mm Hg
3.23  (6.06)
45.Secondary Outcome
Title Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Hide Description Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mm Hg
0.44  (5.13)
46.Secondary Outcome
Title Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Hide Description Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mm Hg
-0.14  (6.81)
47.Secondary Outcome
Title Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Hide Description Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2.33  (7.34)
48.Secondary Outcome
Title Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Hide Description Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm Hg
-1.21  (5.25)
49.Secondary Outcome
Title Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Hide Description Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mm Hg
0.30  (6.60)
50.Other Pre-specified Outcome
Title Number of Pre-emergent and Post-emergent Adverse Events
Hide Description Number of pre-emergent and post-emergent adverse events (AEs)
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: events
44
51.Other Pre-specified Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet
Hide Description ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
0
52.Other Pre-specified Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet
Hide Description ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
0
53.Other Pre-specified Outcome
Title Change in Heart Rate After 140 Days of Following Nic's Keto Diet
Hide Description Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: bpm
0.61  (9.06)
54.Other Pre-specified Outcome
Title Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet
Hide Description Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-2.82  (1.49)
55.Other Pre-specified Outcome
Title Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet
Hide Description Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: U/L
-1.01  (7.82)
56.Other Pre-specified Outcome
Title Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet
Hide Description Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: U/L
0.08  (6.95)
57.Other Pre-specified Outcome
Title Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet
Hide Description Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: µmol/L
0.23  (5.63)
58.Other Pre-specified Outcome
Title Change in Creatinine After 140 Days of Following Nic's Keto Diet
Hide Description Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: µmol/L
3.77  (9.58)
59.Other Pre-specified Outcome
Title Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Hide Description Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.92  (2.33)
60.Other Pre-specified Outcome
Title Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Hide Description Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.12  (0.46)
61.Other Pre-specified Outcome
Title Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Hide Description Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.23  (1.92)
62.Other Pre-specified Outcome
Title Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Hide Description Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.14  (0.16)
63.Other Pre-specified Outcome
Title Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet
Hide Description Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
-5.00  (11.08)
64.Other Pre-specified Outcome
Title Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet
Hide Description Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^9 neutrophils/L
-0.53  (1.21)
65.Other Pre-specified Outcome
Title Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet
Hide Description Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^9 lymphocytes/L
-0.17  (0.47)
66.Other Pre-specified Outcome
Title Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet
Hide Description Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^9 monocytes/L
-0.06  (0.14)
67.Other Pre-specified Outcome
Title Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet
Hide Description Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^9 eosinophils/L
0.00  (0.08)
68.Other Pre-specified Outcome
Title Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet
Hide Description Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^9 basophils/L
0.00  (0.04)
69.Other Pre-specified Outcome
Title Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet
Hide Description Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^12 RBC/L
-0.05  (0.20)
70.Other Pre-specified Outcome
Title Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet
Hide Description Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
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Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: g/L
-1.46  (6.31)
71.Other Pre-specified Outcome
Title Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet
Hide Description Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
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The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: l/l
0.00  (0.02)
72.Other Pre-specified Outcome
Title Change in Platelet Count After 140 Days of Following Nic's Keto Diet
Hide Description Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
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Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: x10^9 platelets/L
15.85  (30.56)
73.Other Pre-specified Outcome
Title Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet
Hide Description Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
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Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: fl
0.85  (1.41)
74.Other Pre-specified Outcome
Title Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet
Hide Description Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
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Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: pg
-0.08  (0.95)
75.Other Pre-specified Outcome
Title Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet
Hide Description Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
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Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: g/L
-3.69  (7.48)
76.Other Pre-specified Outcome
Title Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet
Hide Description Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
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Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percentage of variation
0.37  (0.71)
77.Other Pre-specified Outcome
Title Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet
Hide Description Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame 140 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description:
Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: fl
-0.20  (0.26)
Time Frame 140 days
Adverse Event Reporting Description During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
 
Arm/Group Title Nic's Keto Diet
Hide Arm/Group Description Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
All-Cause Mortality
Nic's Keto Diet
Affected / at Risk (%)
Total   0/14 (0.00%)    
Hide Serious Adverse Events
Nic's Keto Diet
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nic's Keto Diet
Affected / at Risk (%) # Events
Total   10/14 (71.43%)    
Endocrine disorders   
Amenorrhoea   1/14 (7.14%)  1
Gastrointestinal disorders   
Constipation   2/14 (14.29%)  4
Diarrhoea   2/14 (14.29%)  3
Vomiting   2/14 (14.29%)  2
Dyspepsia   1/14 (7.14%)  1
Nausea   1/14 (7.14%)  1
Oropharyngeal pain   1/14 (7.14%)  1
Abdominal discomfort   1/14 (7.14%)  1
General disorders   
Malaise   2/14 (14.29%)  2
Infections and infestations   
Nasopharyngitis   1/14 (7.14%)  1
Injury, poisoning and procedural complications   
Limb injury   1/14 (7.14%)  1
Sunburn   1/14 (7.14%)  1
Investigations   
Haemoglobin decreased   1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Back pain   1/14 (7.14%)  1
Nervous system disorders   
Headache   4/14 (28.57%)  7
Dizziness   2/14 (14.29%)  2
Insomnia   1/14 (7.14%)  1
Psychiatric disorders   
Anxiety   1/14 (7.14%)  1
Insomnia   1/14 (7.14%)  1
Irritability   1/14 (7.14%)  1
Mood altered   1/14 (7.14%)  1
Sleep disorder   4/14 (28.57%)  4
Respiratory, thoracic and mediastinal disorders   
Nasopharyngitis   2/14 (14.29%)  2
Cough   1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
Acne   1/14 (7.14%)  1
Vascular disorders   
Vessel puncture site bruise   1/14 (7.14%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI is an employee of the CRO that conducted the study. The research agreement indicates that the data is the property of the sponsor and therefore they control the option for disclosing results.
Results Point of Contact
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Name/Title: Nikolaos Tzenios
Organization: TRCGEN+ (managed by Trans Russian Co)
Phone: +447583902071
EMail: Nicolas@trccolleges.com
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Responsible Party: TRC GEN+ managed by Trans Russian co Cy
ClinicalTrials.gov Identifier: NCT04195594    
Other Study ID Numbers: 19KLHT
First Submitted: December 4, 2019
First Posted: December 12, 2019
Results First Submitted: February 9, 2021
Results First Posted: May 4, 2021
Last Update Posted: May 4, 2021