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

Touro University, California4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cholesterol Metabolism Ketone Metabolism

Interventions

Standard American dietOTHER

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

Very low carbohydrate dietOTHER

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Touro University California

Vallejo, California, United States

Outcomes

Primary Outcomes

Change in total cholesterol

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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: Day 3-7 to Day 17-21

Secondary Outcomes

Change in fractional hepatic de novo lipogenesis

Measured by the detection of incorporated 1-13C sodium acetate into palmitate in triglyceride rich lipoproteins (TRL)

Time frame: Day 3 to Day 17

Change in fractional cholesterol synthesis

Measured by the detection of incorporated 1-13C sodium acetate into cholesterol in plasma

Time frame: Day 3 to Day 17

Change in ketone body synthesis

Measured by the detection of incorporated 1-13C sodium acetate into ketone bodies in plasma

Time frame: Day 3 to Day 17

Data from ClinicalTrials.gov

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