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NCT06169137 · ClinicalTrials.gov registry record · NA
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
A NA study of Obesity and Body Weight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06169137 is a NA study of Obesity and Body Weight that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06169137, a NA study of Obesity and Body Weight, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BEHAVIORAL Early Time-Restricted Eating
- BEHAVIORAL Conventional dietary regimen (12-hr, 9:30a-9:30p)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2027-02-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06169137
The ClinicalTrials.gov registry entry for NCT06169137 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Early Time-Restricted Eating is the first listed.
NCT06169137 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06169137 about?
NCT06169137 is a clinical study titled "Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation". 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 siz...
What is the current status of trial NCT06169137?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-09-04. Estimated completion is 2027-02-05.
What conditions does trial NCT06169137 study?
This clinical trial studies the following conditions: Obesity, Body Weight.
What interventions are being tested in trial NCT06169137?
The interventions under investigation include: Early Time-Restricted Eating (BEHAVIORAL), Conventional dietary regimen (12-hr, 9:30a-9:30p) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06169137?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06169137 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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