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

Cholesterol Metabolism Clinical Trial

— PLAK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901014
• Other study ID #: M-0419
• Status: Completed
• Phase: N/A
• Start date: March 31, 2019
• Est. completion date: April 18, 2019

Study information

• Verified date: November 2022
• Source: Touro University, California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cholesterol Metabolism
• Ketone Metabolism

Intervention

Other:
• Standard American diet
Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.
• Very low carbohydrate diet
Ketogenic diet with <50g carbohydrate, 60-75% energy from fat, and 20% from protein

Locations

Country	Name	City	State
United States	Touro University California	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Touro University, California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in fractional hepatic de novo lipogenesis	Measured by the detection of incorporated 1-13C sodium acetate into palmitate in triglyceride rich lipoproteins (TRL)	Day 3 to Day 17
Secondary	Change in fractional cholesterol synthesis	Measured by the detection of incorporated 1-13C sodium acetate into cholesterol in plasma	Day 3 to Day 17
Secondary	Change in ketone body synthesis	Measured by the detection of incorporated 1-13C sodium acetate into ketone bodies in plasma	Day 3 to Day 17
Secondary	Change in TRL-triglyceride kinetics	Change in TRL- triglyceride assembly rates as measured using 2-13C glycerol and mathematical modeling	Day 3 to Day 17
Secondary	Change in triglyceride lipolysis	Measured by the dilution of administered 2-13C glycerol in plasma	Day 3 to Day 17
Secondary	Change in serum glucose concentration	Change in fasting and postprandial serum glucose levels	Day 3 to Day 17
Secondary	Change in serum free fatty acid concentration	Change in fasting and postprandial serum free fatty acid levels	Day 3 to Day 17
Secondary	Change in serum insulin concentration	Change in fasting and postprandial serum insulin levels	Day 3 to Day 17
Secondary	Change in serum ketone body concentration	Change in fasting and postprandial ketone body levels	Day 3 to Day 17