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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195594
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
TRC GEN+ managed by Trans Russian co Cy

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.

Condition or disease Intervention/treatment Phase
Ketogenic Dieting Healthy Other: Nic's Keto Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Nic's Keto Diet 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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Changes to weight as assessed by BMI from baseline to day 70 following Nic's Keto Diet [ Time Frame: 70 days ]
  6. Changes to weight as assessed by BMI from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Changes to weight from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
  4. Changes to weight from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
  5. Changes to weight from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
  6. Changes to weight from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
  7. Changes to blood pressure from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
  8. Changes to blood pressure from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
  9. Changes to blood pressure from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
  10. Changes to blood pressure from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
  11. Changes to blood pressure from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
  12. Changes to total cholesterol from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L

  13. Changes to triglyceride level from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L

  14. Changes to HDL-Cholesterol from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L

  15. Changes to LDL-Cholesterol from baseline to day 28 following Nic's Keto Diet [ Time Frame: 28 days ]
    blood analysis. Units in mmol/L

  16. Changes to total cholesterol from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L

  17. Changes to triglyceride level from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L

  18. Changes to HDL-Cholesterol from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L

  19. Changes to LDL-Cholesterol from baseline to day 56 following Nic's Keto Diet [ Time Frame: 56 days ]
    blood analysis. Units in mmol/L

  20. Changes to total cholesterol from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L

  21. Changes to triglyceride level from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L

  22. Changes to HDL-Cholesterol from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L

  23. Changes to LDL-Cholesterol from baseline to day 84 following Nic's Keto Diet [ Time Frame: 84 days ]
    blood analysis. Units in mmol/L

  24. Changes to total cholesterol from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L

  25. Changes to triglyceride level from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L

  26. Changes to HDL-Cholesterol from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L

  27. Changes to LDL-Cholesterol from baseline to day 112 following Nic's Keto Diet [ Time Frame: 112 days ]
    blood analysis. Units in mmol/L

  28. Changes to total cholesterol from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L

  29. Changes to triglyceride level from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L

  30. Changes to HDL-Cholesterol from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L

  31. Changes to LDL-Cholesterol from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
    blood analysis. Units in mmol/L

  32. Changes to HbA1c from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
  33. Changes to fasting glucose from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]
  34. Changes to free tri-iodothyronine (T3) from baseline to day 140 following Nic's Keto Diet [ Time Frame: 140 days ]

Other Outcome Measures:
  1. Incidence of pre-emergent and post-emergent adverse events [ Time Frame: 140 days ]
  2. Change in Electrocardiogram (ECG) after 70 days of following Nic's Keto Diet [ Time Frame: 70 days ]
    Incidence in abnormal report will be analysed

  3. Change in Electrocardiogram (ECG) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Incidence in abnormal report will be analysed

  4. Change in heart rate after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
  5. Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
  6. Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  7. Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  8. Change in total bilirubin after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  9. Change in creatinine after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  10. Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  11. Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  12. Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  13. Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  14. Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  15. Change in amount of neutrophils after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  16. Change in amount of lymphocytes after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  17. Change in amount of monocytes after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  18. Change in amount of eosinophils after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  19. Change in amount of basophils after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  20. Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  21. Change in hemoglobin levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  22. Change in hematocrit levels after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  23. Change in platelet count after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  24. Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  25. Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  26. Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  27. Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis

  28. Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet [ Time Frame: 140 days ]
    Blood analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195594


Contacts
Layout table for location contacts
Contact: Mal Evans, PhD 5194389374 mevans@kgkscience.com

Locations
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Canada, Ontario
KGK Science Inc. Recruiting
London, Ontario, Canada, N6A 5R8
Contact: Mal Evans, PhD    5194389374    mevans@kgkscience.com   
Principal Investigator: David Crowley, MD         
Sponsors and Collaborators
TRC GEN+ managed by Trans Russian co Cy
KGK Science Inc.
Investigators
Layout table for investigator information
Principal Investigator: David Crowley, MD KGK Science Inc.

Layout table for additonal information
Responsible Party: TRC GEN+ managed by Trans Russian co Cy
ClinicalTrials.gov Identifier: NCT04195594    
Other Study ID Numbers: 19KLHT
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TRC GEN+ managed by Trans Russian co Cy:
Ketogenic Diet
Nic's keto diet
Cardiovascular health
Elevated LDL levels