Understanding how a ketogenic diet affects cholesterol levels
Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
NA · Washington University School of Medicine · NCT06894004
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06894004 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypercholesterolemia and Hyperlipidemia, LDL-cholesterol, cholesterol, ketogenic diet, lipoprotein kinetics