Ketogenic Diet in Healthy Adults With Differing BMI

Completed · Not applicable

Conditions studied: Cardiovascular Diseases

In brief

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

Key facts

Study ID

NCT06515912

Run by

Penn State University

People needed

25

Starts

2025-01-29

Expected to finish

2026-03-31

Last updated by the study team

2026-04-15

Who can join

Age: 25 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Prior cardiovascular event (e.g., stroke, heart attack)
• Current pregnancy or intention of pregnancy within the next 2 months
• Lactation within prior 6 months
• Follows a vegetarian or vegan diet
• Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
• Antibiotic use within the prior 1 month
• Oral steroid use within the prior 1 month
• Use of tobacco or nicotine containing products within the past 6 months
• Cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
• Participation in another clinical trial within 30 days of baseline
• Currently following a restricted or weight loss diet
• Previously consumed the ketogenic diet for more than 1 week
• Prior bariatric surgery
• Intake of >14 alcoholic drinks/week and/or lack of willingness to consume no alcohol while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
• Current or past eating disorder
• Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements including being able to come to the metabolic kitchen to pick-up food five days per week
• Planning to relocate out of the State College area in the next 2 months
• Unwilling to refrain from plasma/blood donations during the study
• Previously diagnosed familial hypercholesterolemia
• If a potential participant takes thyroid medicine, abnormal thyroid stimulating hormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)

Where it is running

• Penn State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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