Understanding how a ketogenic diet affects cholesterol levels
Official title: Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
Run by Washington University School of Medicine · NCT06894004 · Data updated 2026-11-12
This study is testing how a very-low carbohydrate ketogenic diet affects cholesterol levels in normal-weight adults who might be more likely to have high cholesterol on this diet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 39 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | February 24, 2025 |
| Main results expected | November 30, 2030 |
| Study ends | November 30, 2030 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT06894004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are normal-weight adults aged 18 to 40 who are at low cardiovascular risk and do not have a history of familial hypercholesterolemia.
✕Probably not a fit
Patients with a personal or family history of familial hypercholesterolemia or those currently using lipid-lowering medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how a very-low carbohydrate ketogenic diet can lead to increased cholesterol levels in normal-weight adults. It will first screen participants to identify those who are susceptible to developing high cholesterol on this diet. Eligible participants will undergo a randomized crossover study involving two different dietary interventions: a ketogenic diet and a control diet, with measurements of lipoprotein and cholesterol kinetics taken during the study. The goal is to clarify the mechanisms behind diet-induced hypercholesterolemia in susceptible individuals.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary impacts on cholesterol levels, potentially guiding dietary recommendations for individuals at risk of hypercholesterolemia.
How similar studies have gone: While the effects of ketogenic diets on cholesterol are known, this specific investigation into the mechanisms of diet-induced hypercholesterolemia in normal-weight individuals is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥ 18 and \< 40 years 2. BMI ≥ 18.5 and \< 25.0 kg/m2 3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L) 4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L) 5. HbA1c ≤ 5.6%. Exclusion Criteria: 1. personal or family history of familial hypercholesterolemia 2. current use of lipid-lowering drugs 3. currently on a ketogenic diet and unwilling to change diet 4. current tobacco use 5. hypertension 6. prediabetes or diabetes 7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline 8. oral contraceptive use 9. contraindication to heparin 10. known atherosclerotic cardiovascular disease 11. unwilling to abstain from alcohol
Where it's running
-
Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Max C Petersen, M.D., Ph.D. — Washington University School of Medicine
- Study coordinator: Frannie Wilkinson, M.A.
- Email: francesw@wustl.edu
- Phone: (314) 362-0590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.