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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195594
• Other study ID #: 19KLHT
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: October 13, 2020

Study information

• Verified date: April 2021
• Source: TRC GEN+ managed by Trans Russian co Cy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 13, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Ketogenic Dieting

Intervention

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.

Locations

Country	Name	City	State
Canada	KGK Science Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
TRC GEN+ managed by Trans Russian co Cy	KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Pre-emergent and Post-emergent Adverse Events	Number of pre-emergent and post-emergent adverse events (AEs)	140 days
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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