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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 4, 2019
First Posted Date  ICMJE December 12, 2019
Results First Submitted Date  ICMJE February 9, 2021
Results First Posted Date  ICMJE May 4, 2021
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE January 14, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2021)
  • Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet [ Time Frame: 70 days ]
    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.
  • Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet [ Time Frame: 70 days ]
    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.
  • Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    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.
  • Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    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.
  • Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet [ Time Frame: 70 days ]
    Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
  • Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to weight as assessed by BMI was reported at baseline and compared to day 140.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • Changes to body fat percentage as assessed by DEXA Scan from baseline to day 70 following Nic's Keto Diet [ Time Frame: 70 days ]
    The DEXA scan is a form of X-ray radiation that measures the body tissue density
  • Changes to muscle mass percentage as assessed by DEXA Scan from baseline to day 70 following Nic's Keto Diet [ Time Frame: 70 days ]
    The DEXA scan is a form of X-ray radiation that measures the body tissue density
  • Changes to body fat percentage as assessed by DEXA Scan from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    The DEXA scan is a form of X-ray radiation that measures the body tissue density
  • Changes to muscle mass percentage as assessed by DEXA Scan from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    The DEXA scan is a form of X-ray radiation that measures the body tissue density
  • Changes to weight as assessed by BMI from baseline to day 70 following Nic's Keto Diet [ Time Frame: 70 days ]
  • Changes to weight as assessed by BMI from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2021)
  • The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days [ Time Frame: 140 days ]
    The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.
  • The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days [ Time Frame: 140 days ]
    The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.
  • Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.
  • Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.
  • Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.
  • Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.
  • Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.
  • Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.
  • Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.
  • Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.
  • Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.
  • Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    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)
  • Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    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).
  • Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
  • Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.
  • Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.
  • Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.
  • Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet [ Time Frame: 70 days ]
    Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.
  • Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.
  • Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet [ Time Frame: 70 days ]
    Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
  • Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet [ Time Frame: 28 days ]
    Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.
  • Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet [ Time Frame: 56 days ]
    Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.
  • Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet [ Time Frame: 70 days ]
    Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
  • Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet [ Time Frame: 84 days ]
    Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.
  • Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet [ Time Frame: 112 days ]
    Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.
  • Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet for 140 days [ Time Frame: 140 days ]
  • The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet for 140 days [ Time Frame: 140 days ]
  • Changes to weight from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
  • Changes to weight from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
  • Changes to weight from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
  • Changes to weight from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
  • Changes to blood pressure from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
  • Changes to blood pressure from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
  • Changes to blood pressure from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
  • Changes to blood pressure from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
  • Changes to blood pressure from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
  • Changes to total cholesterol from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L
  • Changes to triglyceride level from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L
  • Changes to HDL-Cholesterol from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L
  • Changes to LDL-Cholesterol from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L
  • Changes to total cholesterol from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L
  • Changes to triglyceride level from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L
  • Changes to HDL-Cholesterol from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L
  • Changes to LDL-Cholesterol from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L
  • Changes to total cholesterol from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L
  • Changes to triglyceride level from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L
  • Changes to HDL-Cholesterol from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L
  • Changes to LDL-Cholesterol from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L
  • Changes to total cholesterol from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L
  • Changes to triglyceride level from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L
  • Changes to HDL-Cholesterol from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L
  • Changes to LDL-Cholesterol from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L
  • Changes to total cholesterol from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L
  • Changes to triglyceride level from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L
  • Changes to HDL-Cholesterol from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L
  • Changes to LDL-Cholesterol from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L
  • Changes to HbA1c from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
  • Changes to fasting glucose from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
  • Changes to free tri-iodothyronine (T3) from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2021)
  • Number of Pre-emergent and Post-emergent Adverse Events [ Time Frame: 140 days ]
    Number of pre-emergent and post-emergent adverse events (AEs)
  • Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet [ Time Frame: 70 days ]
    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.
  • Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet [ Time Frame: 140 days ]
    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.
  • Change in Heart Rate After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.
  • Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Creatinine After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet
  • Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Platelet Count After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.
  • Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet [ Time Frame: 140 days ]
    Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.
Original Other Pre-specified Outcome Measures
 (submitted: December 9, 2019)
  • Incidence of pre-emergent and post-emergent adverse events [ Time Frame: 140 days ]
  • Change in Electrocardiogram (ECG) after 70 days of following Nic's Keto Diet [ Time Frame: 70 days ]
    Incidence in abnormal report will be analysed
  • Change in Electrocardiogram (ECG) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Incidence in abnormal report will be analysed
  • Change in heart rate after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
  • Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
  • Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in total bilirubin after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in creatinine after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in amount of neutrophils after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in amount of lymphocytes after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in amount of monocytes after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in amount of eosinophils after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in amount of basophils after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in hemoglobin levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in hematocrit levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in platelet count after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
  • Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis
 
Descriptive Information
Brief Title  ICMJE An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
Official Title  ICMJE An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
Brief Summary The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-Label
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Ketogenic Dieting
  • Healthy
Intervention  ICMJE Other: 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.
Study Arms  ICMJE Experimental: Nic's Keto Diet
Intervention: Other: Nic's Keto Diet
Publications * Tzenios N, Lewis ED, Crowley DC, Chahine M, Evans M. Examining the Efficacy of a Very-Low-Carbohydrate Ketogenic Diet on Cardiovascular Health in Adults with Mildly Elevated Low-Density Lipoprotein Cholesterol in an Open-Label Pilot Study. Metab Syndr Relat Disord. 2022 Mar;20(2):94-103. doi: 10.1089/met.2021.0042. Epub 2021 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2019)		 14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 13, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provided voluntary, written, informed consent to participate in study
  2. Males and females between 30 and 55 years of age
  3. BMI between 20.0 to 29.9 kg/m2, inclusive

  4. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or,

    Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:

    • Non hormonal contraceptives
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner at least 6 months prior to screening
  5. Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels
  6. Agrees to maintain current level of physical activity throughout the study
  7. Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits.
  8. Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
  2. Women who are menopausal or post-menopausal
  3. Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet)
  4. Subjects with high TSH level (>4.5mU/L) or Self reported pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  5. Participants with type I or II Diabetes Mellitus
  6. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
  7. Participants with previous or current pathology of the pancreas
  8. Current or history of Gastroesophageal reflux disease (GERD) or any significant disease of the gastrointestinal tract
  9. Self reported hypertension or on hypertensives.
  10. Significant cardiovascular event in the past 6 months as assessed by the QI.
  11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
  12. Gastric bypass surgery
  13. Individuals with an autoimmune disease or are immune-compromised
  14. Self reported HIV-, Hepatitis B- and/or C-positive diagnosis
  15. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
  16. Self reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
  17. Self reported blood/bleeding disorders as per QI
  18. Current use of prescribed medications listed in Section 7.3.1
  19. Current use of over-the-counter medications, supplements, foods, and/or drinks listed in Section 7.3.2
  20. Alcohol or drug abuse within the last 12 months
  21. High alcohol intake (>2 standard drinks per day or >10 standard drinks per week)
  22. Clinically significant abnormal laboratory results at screening as assessed by the QI
  23. Metal implants that may affect the DEXA scan results will be assessed on case-by-case basis by the QI
  24. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
  25. Participation in a clinical research trial within 30 days of study initiation
  26. Individuals who are unable to give informed consent
  27. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or may pose significant risk to the participant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04195594
Other Study ID Numbers  ICMJE 19KLHT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TRC GEN+ managed by Trans Russian co Cy
Study Sponsor  ICMJE TRC GEN+ managed by Trans Russian co Cy
Collaborators  ICMJE KGK Science Inc.
Investigators  ICMJE
Principal Investigator: David Crowley, MD KGK Science Inc.
PRS Account TRC GEN+ managed by Trans Russian co Cy
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP