Status:
RECRUITING
Ketogenic Diet in Healthy Adults With Differing BMI
Lead Sponsor:
Penn State University
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
25-45 years
Phase:
NA
Brief 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 ...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06515912
Start Date
January 29 2025
End Date
December 1 2025
Last Update
May 28 2025
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802