Ketogenic Diet in Healthy Adults With Differing BMI

NCT ID: NCT06515912

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2025-12-31

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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low BMI

BMI 18.5 - 22 kg/m\^2 Intervention: Ketogenic diet 28 days

Group Type: EXPERIMENTAL

Ketogenic Diet

Intervention Type: OTHER

A ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal.

High BMI

BMI 30-35 kg/m\^2 Intervention: Ketogenic diet 28 days

Group Type: ACTIVE_COMPARATOR

Ketogenic Diet

Intervention Type: OTHER

A ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal.

Interventions

Ketogenic Diet

A ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Kristina Petersen PhD, APD, FAHA

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State University

University Park, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristina S Petersen, PhD

Role: CONTACT

kup63@psu.edu

814-865-7206

Stacey Meily

Role: CONTACT

sas117@psu.edu

814-863-8622

Facility Contacts

Kristina Petersen, PhD

Role: primary

kup63@psu.edu

814-865-7206

Stacey Meily

Role: backup

sas117@psu.edu

814-863-8622

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

KTO

Identifier Type: -

Identifier Source: org_study_id