Effects of a Ketogenic Diet on Heart Health in Adults with Different BMIs
The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults With Differing BMI
This study tests if a ketogenic diet affects heart health differently in healthy adults and those with obesity by looking at changes in cholesterol and blood vessel health over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | All |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT06515912 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a ketogenic diet over four weeks on blood lipid levels and cardiovascular risk factors in healthy adults with varying body mass indices (BMIs). Participants will consume provided meals and attend daily visits to a metabolic kitchen, along with five fasting visits for testing at a Clinical Research Center. The study aims to determine if the ketogenic diet leads to greater increases in 'bad cholesterol' and decreases in vascular health in individuals with a healthy BMI compared to those with obesity.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 25-45 with a BMI between 18.5-22 kg/m2 or 30-35 kg/m2 and specific lipid and glucose levels.
Not a fit: Patients with diabetes, cardiovascular disease, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how dietary interventions like the ketogenic diet affect heart health differently based on body weight.
How similar studies have performed: While there have been studies on the ketogenic diet, this specific approach comparing healthy adults with differing BMIs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 cease during 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 without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years 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 alcohol while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hours prior to test visits 19. Current or past eating disorder 20. 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 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 stimulating hormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)
Where this trial is running
University Park, Pennsylvania
- Penn State University — University Park, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Kristina S Petersen, PhD
- Email: kup63@psu.edu
- Phone: 814-865-7206
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.