An interventional study of Standard American diet and Very low carbohydrate diet in Cholesterol Metabolism and Ketone Metabolism, sponsored by Touro University, California. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Touro University, California · Not applicable, Interventional, and Basic science
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.
Touro University, California is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 week baseline diet
Other: Standard American diet
2 week very low carbohydrate ketogenic diet
Other: Very low carbohydrate diet
Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.
Ketogenic diet with \<50g carbohydrate, 60-75% energy from fat, and 20% from protein
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
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
Change in TRL-triglyceride kinetics
Change in TRL- triglyceride assembly rates as measured using 2-13C glycerol and mathematical modeling
Time frame: Day 3 to Day 17
Change in triglyceride lipolysis
Measured by the dilution of administered 2-13C glycerol in plasma
Time frame: Day 3 to Day 17
Change in serum glucose concentration
Change in fasting and postprandial serum glucose levels
Time frame: Day 3 to Day 17
Change in serum free fatty acid concentration
Change in fasting and postprandial serum free fatty acid levels
Time frame: Day 3 to Day 17
Change in serum insulin concentration
Change in fasting and postprandial serum insulin levels
Time frame: Day 3 to Day 17
Change in serum ketone body concentration
Change in fasting and postprandial ketone body levels
Time frame: Day 3 to Day 17
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Touro University, California