Clinical trial NCT04195594: An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogenic Dieting
Healthy
Keywords: Ketogenic Diet
Nic's keto diet
Cardiovascular health
Elevated LDL levels
Lead sponsor: TRC GEN+ managed by Trans Russian co Cy
Sponsor class: OTHER
Collaborators: name: KGK Science Inc.
First posted: 2019-12-12
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
timeFrame: 70 days
measure: Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
timeFrame: 70 days
measure: Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet
timeFrame: 70 days
measure: Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
Secondary outcomes:
measure: The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days
timeFrame: 140 days
measure: The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days
timeFrame: 140 days
measure: Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet
timeFrame: 70 days
measure: Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
measure: Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
timeFrame: 70 days
measure: Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
timeFrame: 28 days
measure: Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
timeFrame: 56 days
measure: Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
timeFrame: 70 days
measure: Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
timeFrame: 84 days
measure: Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
timeFrame: 112 days
measure: Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
timeFrame: 140 days
Other outcomes:
measure: Number of Pre-emergent and Post-emergent Adverse Events
timeFrame: 140 days
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet
timeFrame: 70 days
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Heart Rate After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Creatinine After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Platelet Count After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
measure: Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet
timeFrame: 140 days
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.