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

An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Ketogenic Dieting
• Intervention / Treatment: Other: Nic's Keto Diet

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet	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.	70 days
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet	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.	70 days
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet	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.	140 days
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet	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.	140 days
Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet	Changes to weight as assessed by BMI was reported at baseline and compared to day 70.	70 days
Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet	Changes to weight as assessed by BMI was reported at baseline and compared to day 140.	140 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 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.	140 days
The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 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.	140 days
Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet	Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.	28 days
Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet	Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.	56 days
Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet	Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.	84 days
Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet	Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.	112 days
Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet	Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.	28 days
Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet	Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.	56 days
Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet	Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.	84 days
Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet	Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.	112 days
Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet	Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.	140 days
Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet	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)	28 days
Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet	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).	28 days
Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet	Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	28 days
Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet	Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	28 days
Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet	Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	56 days
Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet	Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	56 days
Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet	Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	56 days
Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet	Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	56 days
Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet	Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	84 days
Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet	Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	84 days
Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet	Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	84 days
Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet	Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	84 days
Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet	Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	112 days
Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet	Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	112 days
Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet	Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	112 days
Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet	Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	112 days
Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet	Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	140 days
Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet	Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	140 days
Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet	Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	140 days
Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet	Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).	140 days
Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet	Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.	140 days
Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet	Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.	140 days
Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet	Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.	140 days
Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet	Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.	70 days
Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet	Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.	140 days
Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet	Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.	70 days
Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet	Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.	28 days
Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet	Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.	56 days
Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet	Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.	70 days
Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet	Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.	84 days
Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet	Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.	112 days
Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet	Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.	140 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Pre-emergent and Post-emergent Adverse Events	Number of pre-emergent and post-emergent adverse events (AEs)	140 days
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet	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.	70 days
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet	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.	140 days
Change in Heart Rate After 140 Days of Following Nic's Keto Diet	Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.	140 days
Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet	Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet	Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet	Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet	Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Creatinine After 140 Days of Following Nic's Keto Diet	Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet	Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet	Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet	140 days
Change in Chloride 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 compared to baseline.	140 days
Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet	Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet	Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet	Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet	Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet	Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet	Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet	Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet	Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet	Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet	Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Platelet Count After 140 Days of Following Nic's Keto Diet	Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet	Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet	Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet	Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet	Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.	140 days
Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet	Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.	140 days

Collaborators and Investigators

• Sponsor: TRC GEN+ managed by Trans Russian co Cy
• Collaborators: KGK Science Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Actual): October 13, 2020
• Study Completion (Actual): October 13, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Ketogenic Diet; Cardiovascular health; Nic's keto diet; Elevated LDL levels
• Other Study ID Numbers: 19KLHT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No