Ketogenic Diet in Healthy Adults With Differing BMI

Last updated: May 27, 2025
Sponsor: Penn State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Ketogenic Diet

Clinical Study ID

NCT06515912
KTO
  • Ages 25-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 25-45 years

  2. Fasting direct LDL-C ≤100 mg/dL

  3. BMI of 18.5-22 kg/m2 or 30-35 kg/m2

  4. Blood pressure <140/90 mmHg

  5. Fasting blood glucose <126 mg/dL

  6. Fasting triglycerides <350 mg/dL

  7. ≤10% change in body weight for 6 months prior to enrollment

Exclusion

Exclusion Criteria:

  1. Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL

  2. Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs

  3. Intake of supplements that affect the outcomes of interest and unwilling to ceaseduring the study period

  4. Diagnosed liver, kidney, or autoimmune disease

  5. Prior cardiovascular event (e.g., stroke, heart attack)

  6. Current pregnancy or intention of pregnancy within the next 2 months

  7. Lactation within prior 6 months

  8. Follows a vegetarian or vegan diet

  9. Food allergies/intolerance/sensitives/dislikes of foods included in the study menu

  10. Antibiotic use within the prior 1 month

  11. Oral steroid use within the prior 1 month

  12. Use of tobacco or nicotine containing products within the past 6 months

  13. Cancer at any site within the past 10 years (eligible if ≥10 years withoutrecurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5years without recurrence)

  14. Participation in another clinical trial within 30 days of baseline

  15. Currently following a restricted or weight loss diet

  16. Previously consumed the ketogenic diet for more than 1 week

  17. Prior bariatric surgery

  18. Intake of >14 alcoholic drinks/week and/or lack of willingness to consume no alcoholwhile enrolled in the study and/or not willing to avoid alcohol consumption for 48hours prior to test visits

  19. Current or past eating disorder

  20. Principal Investigator discretion related to the potential participant's ability toadhere to the study requirements including being able to come to the metabolickitchen to pick-up food five days per week

  21. Planning to relocate out of the State College area in the next 2 months

  22. Unwilling to refrain from plasma/blood donations during the study

  23. Previously diagnosed familial hypercholesterolemia

  24. If a potential participant takes thyroid medicine, abnormal thyroid stimulatinghormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Ketogenic Diet
Phase:
Study Start date:
January 29, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Penn State University

    University Park, Pennsylvania 16802
    United States

    Active - Recruiting

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