NCT06515912

Ketogenic Diet in Healthy Adults With Differing BMI

The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults With Differing BMI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a controlled feeding study investigating if four weeks on the ketogenic diet will cause differential alterations in blood lipids and lipoproteins, vascular health as measured by fasting flow mediated dilation (FMD), and mechanistic markers of lipid metabolism in adults with normal weight when compared to adults with obesity. Outcomes will be measured at both the beginning and end of the study on two consecutive days, for a total of four clinic appointments.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Ketogenic Diet	A ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal.

Timeline

• Start date: 2025-01-29
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-07-23
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States