An interventional study of Ketogenic Diet and Control Diet in Hypercholesterolemia and Hyperlipidemia, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Basic science
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.
This study will evaluate the mechanism of ketogenic diet-induced hypercholesterolemia in susceptible normal-weight adults. The first stage of screening will identify eligible young adults who are normal-weight and at low cardiovascular risk. The second stage of screening will identify "responders" who demonstrate susceptibility to ketogenic diet-induced hypercholesterolemia by displaying an increase in LDL-cholesterol concentration after a 3-week screening ketogenic diet. Responders will be eligible to complete a randomized crossover clinical study at Washington University School of Medicine in St. Louis, MO. The randomized crossover study will involve isotope tracer studies of lipoprotein and cholesterol kinetics after two separate 4-week dietary interventions [ketogenic diet and control diet], conducted in random order with a 4-week washout period between interventions. All food will be provided to the participants as packed-out meals. Certain outcomes will use data from the screening process, comparing screen successes and screen failures to evaluate factors that could influence susceptibility to ketogenic diet-induced hypercholesterolemia.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm A will complete the Ketogenic Diet intervention first, followed by the Control Diet intervention after a 4-week washout period.
Behavioral: Ketogenic Diet · Behavioral: Control Diet
Arm B will complete the Control Diet intervention first, followed by the Ketogenic Diet intervention after a 4-week washout period.
Behavioral: Ketogenic Diet · Behavioral: Control Diet
Participants will consume an isocaloric ketogenic diet for 4 weeks with all food provided as packed-out meals.
Participants will consume an isocaloric control diet for 4 weeks with all food provided as packed-out meals.
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.
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.
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.
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.
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.
LDL-ApoB100 fractional catabolic 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.
VLDL-triglyceride production rate
Determined by using plasma and VLDL glycerol 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.
VLDL-triglyceride fractional catabolic rate
Determined by using plasma and VLDL glycerol 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.
Plasma lipoprotein lipase activity
Determined by assaying lipoprotein lipase activity in post-heparin plasma
Time frame: Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
Plasma lipoprotein profile
Determined by standard clinical chemistry methods and by advanced lipoprotein profiling
Time frame: At baseline, immediately after the screening ketogenic diet, immediately after the 4-week ketogenic diet intervention period, and immediately after the 4-week control diet intervention period.
Whole-body lipolytic rate
Determined by using plasma palmitate isotopic enrichment
Time frame: Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
Relative contribution of systemic fatty acids to VLDL-triglyceride
Determined by using plasma and VLDL-triglyceride palmitate 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.
Cholesterol synthetic rate
Determined by using mass isotopomer distribution analysis of deuterium enrichment in plasma cholesterol after labeling the total body water pool with deuterium oxide
Time frame: Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
Fat mass
Determined by using dual-energy X-ray absorptiometry
Time frame: Immediately after the screening ketogenic diet
Fat-free mass
Determined by using dual-energy X-ray absorptiometry
Time frame: Immediately after the screening ketogenic diet
Insulin sensitivity
Determined by measuring fasting plasma glucose, insulin, and C-peptide
Time frame: Immediately after the screening ketogenic diet
Thyroid function
Determined by measuring TSH, free T4, and free T3
Time frame: Immediately after the screening ketogenic diet
Adipokines
Determined by measuring plasma leptin and adiponectin
Time frame: Immediately after the screening ketogenic diet
Cholesterol absorption markers
Determined by measuring serum campesterol, sitosterol, and cholestanol
Time frame: Immediately after the screening ketogenic diet
Plan to share: Yes — All raw data used to generate descriptive statistics presented in manuscripts incorporating results generated from this study will be included as supplemental data files as and when required. Fully de-identified raw data, including all outcome measures and tracer enrichments from kinetic studies will be available in .csv format, which can be manipulated by many free and commercial software packages. Individual-level data will be shared as allowed by informed consent agreements approved by the Institutional Review Board (IRB).
Supporting information: Study protocol
Time frame: Data will be made available upon peer-reviewed publication of the study results or earlier as required by the study sponsor and/or funding sources.
Access criteria: FAIR Data Sharing protocols will be applied so that the data will be Findable, Accessible, Interoperable, and Re-usable.
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