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

NCT ID: NCT04195594

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-10-13

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.

Conditions

Ketogenic Dieting; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nic's Keto Diet

Group Type: EXPERIMENTAL

Nic's Keto Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

TRC GEN+ managed by Trans Russian co Cy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34918971 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19KLHT

Identifier Type: -

Identifier Source: org_study_id