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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT06169137
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Early Time-Restricted Eating — BEHAVIORAL
    Participants will be provided all meals to consume within a 6-hour timeframe (9:30-3:30p)
  • Conventional dietary regimen (12-hr, 9:30a-9:30p) — BEHAVIORAL
    Participants will be provided all meals to consume within a 12-hour timeframe (9:30a-9:30p)

Study Details

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.

Key Dates

Start date
Sep 4, 2024
Status verified
May 2026
Primary completion
Feb 5, 2027
Completion
Feb 5, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Premenopausal women (lean and obese)
    Ages 18-50 yearsBMI 18.0-24.5 mg/k\^2 or BMI \> 30 mg/k\^2

Primary Outcome Measure

Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra) [ Time Frame: Day 0, Day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222
Stephanie Chung, M.D.
[email protected]
(240) 479-8137

Find similar trials in Bethesda, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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