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

Touro University, California

Status: Completed

Conditions: Ketone Metabolism; Cholesterol Metabolism

Treatments: Other: Very low carbohydrate diet; Other: Standard American diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03901014

M-0419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Baseline diet

Active Comparator group

Description:

1 week baseline diet

Treatment:

Other: Standard American diet

Very low carbohydrate diet

Experimental group

Description:

2 week very low carbohydrate ketogenic diet

Treatment:

Other: Very low carbohydrate diet