Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorWashington University School of Medicine
About this trial
Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age ≥ 18 and < 40 years
BMI ≥ 18.5 and < 25.0 kg/m2
baseline serum LDL-c < 150 mg/dL (< 3.9 mmol/L)
baseline serum TG < 100 mg/dL (< 1.1 mmol/L)
Disqualifiers
personal or family history of familial hypercholesterolemia
current use of lipid-lowering drugs
currently on a ketogenic diet and unwilling to change diet
current tobacco use
Trial design
Design model
Crossover
Treatments tested in this trial
Ketogenic Diet
BehavioralParticipants will consume an isocaloric ketogenic diet for 4 weeks with all food provided as packed-out meals.
Control Diet
BehavioralParticipants will consume an isocaloric control diet for 4 weeks with all food provided as packed-out meals.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: AExperimental treatment 2 interventions
Group B: BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
VLDL-ApoB100 production rate
Determined by using plasma and VLDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Time frame
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.Secondary outcomes
1
VLDL-ApoB100 fractional catabolic rate
Determined by using plasma and VLDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Time frame
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.2
IDL-ApoB100 production rate
Determined by using plasma and IDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Time frame
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.3
IDL-ApoB100 fractional catabolic rate
Determined by using plasma and IDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Time frame
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.4
LDL-ApoB100 production rate
Determined by using plasma and LDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Time frame
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.Sponsors and contacts
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Source ClinicalTrials.gov