Ketogenic Diet in Healthy Adults With Differing BMI (NCT06515912) | Clinical Trial Compass
CompletedNot Applicable
Ketogenic Diet in Healthy Adults With Differing BMI
United States25 participantsStarted 2025-01-29
Plain-language summary
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:
* Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?
* Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity?
Participants will:
* Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
* Visit the metabolic kitchen daily (Monday-Friday) to pick up meals
* Attend 5 fasting visits at the Clinical Research Center for testing
Who can participate
Age range25 Years – 45 Years
SexALL
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Inclusion criteria
✓. Age 25-45 years
✓. Fasting direct LDL-C ≤100 mg/dL
✓. BMI of 18.5-22 kg/m2 or 30-35 kg/m2
✓. Blood pressure \<140/90 mmHg
✓. Fasting blood glucose \<126 mg/dL
✓. Fasting triglycerides \<350 mg/dL
✓. ≤10% change in body weight for 6 months prior to enrollment
Exclusion criteria
✕. Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
✕. Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs
✕. Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
✕. Diagnosed liver, kidney, or autoimmune disease
What they're measuring
1
LDL-cholesterol concentration change from baseline