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

NCT04195594 | Completed Results

• 1 other identifier: 19KLHT
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Ketogenic Diet; Nic's keto diet; Cardiovascular health; Elevated LDL levels

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (43)

• The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 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

  140 days

• Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet

  28 days

• Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet

  56 days

• Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet

  84 days

Other Outcomes (28)

• Number of Pre-emergent and Post-emergent Adverse Events

  140 days

• Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet

  70 days

• Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet

  140 days

Study Arms (1)

Nic's Keto Diet

EXPERIMENTAL

Other: Nic's Keto Diet

Interventions

Nic's Keto Diet 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.

Nic's Keto Diet

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provided voluntary, written, informed consent to participate in study
• Males and females between 30 and 55 years of age
• BMI between 20.0 to 29.9 kg/m2, inclusive
• 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
• Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels
• Agrees to maintain current level of physical activity throughout the study
• Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits.
• Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
• Women who are menopausal or post-menopausal
• Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet)
• 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
• Participants with type I or II Diabetes Mellitus
• 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.
• Participants with previous or current pathology of the pancreas
• Current or history of Gastroesophageal reflux disease (GERD) or any significant disease of the gastrointestinal tract
• Self reported hypertension or on hypertensives.
• Significant cardiovascular event in the past 6 months as assessed by the QI.
• 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
• Gastric bypass surgery
• Individuals with an autoimmune disease or are immune-compromised
• Self reported HIV-, Hepatitis B- and/or C-positive diagnosis
• 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

Sponsors & Collaborators

• TRC GEN+ managed by Trans Russian co Cy: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 34918971 DERIVED

Results Point of Contact

• Title: Nikolaos Tzenios
• Organization: TRCGEN+ (managed by Trans Russian Co)

Nicolas@trccolleges.com

+447583902071

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-Label

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 12, 2019
• Study Start: January 14, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-04

Locations

CA (1)