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

NCT03901014 | Completed

• 1 other identifier: M-0419
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol Metabolism; Ketone Metabolism

Keywords

ketogenic diet; LDL cholesterol; carbohydrate

Outcome Measures

Primary Outcomes (4)

• Change in total cholesterol

  Change in serum total cholesterol between Day 3-7 (average value) to Day 17-21 (average value)

  Day 3-7 to Day 17-21

• Change in low density lipoprotein (LDL) cholesterol

  Change in serum LDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)

  Day 3-7 to Day 17-21

• Change in high density lipoprotein (HDL) cholesterol

  Change in serum HDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)

  Day 3-7 to Day 17-21

• Change in apolipoprotein B (apoB) kinetics

  Change in apoB turnover rates in LDL and very low density lipoprotein plasma fractions as measured using 2H2 leucine incorporation into apoB and mathematical modeling

  Day 3-7 to Day 17-21

Secondary Outcomes (9)

• Change in fractional hepatic de novo lipogenesis

  Day 3 to Day 17

• Change in fractional cholesterol synthesis

  Day 3 to Day 17

• Change in ketone body synthesis

  Day 3 to Day 17

• Change in TRL-triglyceride kinetics

  Day 3 to Day 17

• Change in triglyceride lipolysis

  Day 3 to Day 17

Study Arms (2)

Baseline diet

ACTIVE COMPARATOR

1 week baseline diet

Other: Standard American diet

Very low carbohydrate diet

EXPERIMENTAL

2 week very low carbohydrate ketogenic diet

Other: Very low carbohydrate diet

Interventions

Standard American diet OTHER

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

Baseline diet

Very low carbohydrate diet OTHER

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

Very low carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Touro University, California: lead

Study Sites (1)

Touro University California

Vallejo, California, 94592, United States

Location

Study Officials

• Grace M Jones, PhD

  Touro University, California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The nature of the diet does not allow for masking
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 3, 2019
• Study Start: March 31, 2019
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)