Investigating the Production of Lipoproteins and Acetyl-CoA During a Ketogenic Diet
- Conditions
- Cholesterol MetabolismKetone Metabolism
- Interventions
- Other: Very low carbohydrate dietOther: Standard American diet
- Registration Number
- NCT03901014
- Lead Sponsor
- Touro University, California
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4
- Male
- 18-50 years old
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Very low carbohydrate diet Very low carbohydrate diet 2 week very low carbohydrate ketogenic diet Baseline diet Standard American diet 1 week baseline diet
- Primary Outcome Measures
Name Time Method Change in total cholesterol Day 3-7 to Day 17-21 Change in serum total cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Change in low density lipoprotein (LDL) cholesterol Day 3-7 to Day 17-21 Change in serum LDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Change in high density lipoprotein (HDL) cholesterol Day 3-7 to Day 17-21 Change in serum HDL cholesterol between Day 3-7 (average value) to Day 17-21 (average value)
Change in apolipoprotein B (apoB) kinetics Day 3-7 to Day 17-21 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
- Secondary Outcome Measures
Name Time Method Change in fractional hepatic de novo lipogenesis Day 3 to Day 17 Measured by the detection of incorporated 1-13C sodium acetate into palmitate in triglyceride rich lipoproteins (TRL)
Change in fractional cholesterol synthesis Day 3 to Day 17 Measured by the detection of incorporated 1-13C sodium acetate into cholesterol in plasma
Change in ketone body synthesis Day 3 to Day 17 Measured by the detection of incorporated 1-13C sodium acetate into ketone bodies in plasma
Change in TRL-triglyceride kinetics Day 3 to Day 17 Change in TRL- triglyceride assembly rates as measured using 2-13C glycerol and mathematical modeling
Change in triglyceride lipolysis Day 3 to Day 17 Measured by the dilution of administered 2-13C glycerol in plasma
Change in serum glucose concentration Day 3 to Day 17 Change in fasting and postprandial serum glucose levels
Change in serum free fatty acid concentration Day 3 to Day 17 Change in fasting and postprandial serum free fatty acid levels
Change in serum insulin concentration Day 3 to Day 17 Change in fasting and postprandial serum insulin levels
Change in serum ketone body concentration Day 3 to Day 17 Change in fasting and postprandial ketone body levels
Trial Locations
- Locations (1)
Touro University California
🇺🇸Vallejo, California, United States