Clinical trial NCT03901014: Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
Official title: Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol Metabolism
Ketone Metabolism
Keywords: ketogenic diet
LDL cholesterol
carbohydrate
Lead sponsor: Touro University, California
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Change in total cholesterol
timeFrame: Day 3-7 to Day 17-21
measure: Change in low density lipoprotein (LDL) cholesterol
timeFrame: Day 3-7 to Day 17-21
measure: Change in high density lipoprotein (HDL) cholesterol
timeFrame: Day 3-7 to Day 17-21
measure: Change in apolipoprotein B (apoB) kinetics
timeFrame: Day 3-7 to Day 17-21
Secondary outcomes:
measure: Change in fractional hepatic de novo lipogenesis
timeFrame: Day 3 to Day 17
measure: Change in fractional cholesterol synthesis
timeFrame: Day 3 to Day 17
measure: Change in ketone body synthesis
timeFrame: Day 3 to Day 17
measure: Change in TRL-triglyceride kinetics
timeFrame: Day 3 to Day 17
measure: Change in triglyceride lipolysis
timeFrame: Day 3 to Day 17
measure: Change in serum glucose concentration
timeFrame: Day 3 to Day 17
measure: Change in serum free fatty acid concentration
timeFrame: Day 3 to Day 17
measure: Change in serum insulin concentration
timeFrame: Day 3 to Day 17
measure: Change in serum ketone body concentration
timeFrame: Day 3 to Day 17
Other outcomes:
Locations:
city: Vallejo
country: United States
facility: Touro University California
state: California
Study officials:
affiliation: Touro University, California
name: Grace M Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: