RECRUITING

Ketogenic Diet in Healthy Adults With Differing BMI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults With Differing BMI

Quick Facts

Study Start:2025-02

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06515912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Kristina S Petersen, PhD

CONTACT

814-865-7206

kup63@psu.edu

Stacey Meily

CONTACT

814-863-8622

sas117@psu.edu

Study Locations (Sites)

Penn State University

University Park, Pennsylvania, 16802

United States

Collaborators and Investigators

Sponsor: Penn State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-02

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Ketogenic Diet

Additional Relevant MeSH Terms

Cardiovascular Diseases