Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet

NCT ID: NCT03901014

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2019-04-18

Brief Summary

The purpose of this study is to understand how the reduction in dietary carbohydrates in a very-low carbohydrate ketogenic diet impacts the synthesis of cholesterol, fatty acid, and ketones, and the turnover rate of VLDL and chylomicron particles.

Detailed Description

Participants will consume a standard American diet for one week followed by a very-low carbohydrate ketogenic diet (VLCKD, <50 grams carbohydrate/day) for two weeks. Participants will undergo an oral stable isotope tracer study during each diet to measure de novo synthesis of fatty acid, cholesterol, ketone bodies, and for measurement of apolipoprotein B and triglyceride kinetics.

Conditions

Cholesterol Metabolism; Ketone Metabolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Baseline diet

1 week baseline diet

Group Type: ACTIVE_COMPARATOR

Standard American diet

Intervention Type: OTHER

Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.

Very low carbohydrate diet

2 week very low carbohydrate ketogenic diet

Group Type: EXPERIMENTAL

Very low carbohydrate diet

Intervention Type: OTHER

Ketogenic diet with \<50g carbohydrate, 60-75% energy from fat, and 20% from protein

Interventions

Standard American diet

Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.

Intervention Type: OTHER

Very low carbohydrate diet

Ketogenic diet with \<50g carbohydrate, 60-75% energy from fat, and 20% from protein

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male
• 18-50 years old

Exclusion Criteria

• Use of nicotine products
• Has dietary restrictions
• Lactose intolerance
• History of GI disorders, diabetes, liver, kidney, or thyroid disorders
• Taking hypolipidemic, anti-diabetic, anti-hypertensive, or anti-depression medication
• Screening plasma triglyceride < 50mg/dl or >500mg/dl
• Screening glucose > 125mg/dl
• Screening total and LDL-Cholesterol over 95th %tile for age and sex
• BP > 160/95 mmHg
• Weight loss/gain > 5% in the previous 3 months (self-reported)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Touro University, California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace M Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

Touro University, California

Locations

Touro University California

Vallejo, California, United States

Countries

United States

Other Identifiers

M-0419

Identifier Type: -

Identifier Source: org_study_id