Actively Recruiting
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
150
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health. Objective: To learn how TRE affects women with different body sizes. Eligibility: Healthy women aged 18 to 50 years. Design: Participants will have 2 visits: 1 screening visit and one 5-day stay in the clinic. Participants will fast before both visits. They will have a physical exam with blood tests. They will talk to a nutritionist about the foods they eat. They will lay under a clear hood for up to 45 minutes during a test that measures how many calories they burn while resting. Participants will keep a food diary for up to 7 days before their clinic stay. They will apply a continuous glucose monitor the day before they go to the clinic. This is a device that attaches to the skin of the stomach. They will wear this device throughout their clinic stay. All meals will be provided during the clinic stay. Participants will follow TRE on 3 days. They will answer survey questions and have tests during their stay, including: * DXA (dual energy X-ray absorptiometry) scan. Participants will lie on a padded table. Their body will be scanned to measure how much muscle, bone, fat, and other tissues they have. * Stable isotope tracer study. Small amounts of sugar and other substances will be given through a tube attached to a needle inserted into a vein in the arm. Blood samples will be collected.
CONDITIONS
Official Title
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to follow all study procedures and be available for the entire study duration
- Female, aged 18 to 50 years, premenopausal (regular menstruation and/or normal FSH levels)
- Body mass index (BMI) of 18 to 24.9 or 30 kg/m2 and above
- In good general health based on medical history and lab tests
- Agree to follow lifestyle guidelines during the study
You will not qualify if you...
- Diagnosis or treatment of immune/inflammatory disorders, diabetes, chronic kidney or liver disease, hypoglycemia history, or thyroid disease (except controlled hypothyroidism)
- Use of medications affecting blood sugar, steroids, stimulants, sleep, circadian rhythms, or metabolism that impact study parameters
- Consuming more than 300 mg of caffeine daily (about three 8-oz cups of coffee)
- Factors disrupting circadian rhythms such as overnight shift work, irregular sleep/eating schedules, or fasting over 15 hours daily
- History of eating disorders
- Food allergies or diets that prevent eating study meals
- Unable to give informed consent
- Pregnancy or breastfeeding
- Unstable weight with over 5% change in past 3 months
- Involved in competitive sports training or unwilling to follow exercise plan
- Drinking more than 3 alcoholic drinks daily
- Current smoker or nicotine use in past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Lilian S Mabundo
CONTACT
S
Stephanie T Chung, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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