Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Obesity and Body Weight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Within subject difference in ketone body (beta hydroxybutyrate) rate of appearance (Ra) after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
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 |
What NCT06169137 shows while recruiting
NCT06169137 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06169137's enrollment target sits among peer trials
150 370th of 1053 higher than 668 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Metabolic Adaptations to Weight Loss With and Without Exercise
RECRUITING · NA
-
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
RECRUITING · NA
-
Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery
RECRUITING · NA
-
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
RECRUITING · NA
-
SMARTer Weight Loss Management
RECRUITING · NA
-
HealthyTogether: RCT of a Dyadic Weight Management Intervention
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI