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Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation

NCT06169137 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Early Time-Restricted Eating

Participants will be provided all meals to consume within a 6-hour timeframe (9:30-3:30p)

BEHAVIORAL

Conventional dietary regimen (12-hr, 9:30a-9:30p)

Participants will be provided all meals to consume within a 12-hour timeframe (9:30a-9:30p)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Stephanie T Chung, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2027-02-05
Completion
2027-02-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169137 on ClinicalTrials.gov