NCT05548517Completed
TRE: Microbiome, Metabolic Health and Bone
Time Restricted Eating on the Microbiome Affecting Metabolic Health and Bone in Older Women
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on bone health, as well as body weight and the gut microbiota in older women who are overweight or obese.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 14 Sept 2022
- Start date
- 15 Oct 2022
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- Obesity
- NCT number
- NCT05548517
What you commit to
- Study type: Interventional
- Participants enrolled: 49
- From 15 Oct 2022 to the primary completion date, 15 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
- Alcohol or illicit drug abuse
Other illness
- Current diagnosis, or history of cancer in past 3 years
- History of surgical procedure for weight loss in the past 3 years
- Current diagnosis or history of bone diseases, type I or II diabetes, gastrointestinal disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease
- Uncontrolled hypertension or hyperlipidemia in abnormal ranges
Other
- Participants with \>5% weight loss in the past 6 months or extreme dietary/physical activity habits
- An inability to follow the experimental intervention or to perform the required specimen collections
- Antibiotic use in the past 2 months
- A colonoscopy within the past 2 months
- Current smoker or having quit smoking in the past 3 months
- Shift work
- Participation in another clinical research trial which may interfere with the results of this study.
Who the study is looking for
- Postmenopausal women (\>2 years since last menses)
- Body mass index (25-45 kg/m2)
- Agree to be randomly assigned to consume food for ≤ 9 hours/day or ≥12 hours/day
- Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
Age in the registry: 50 years to 79 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers University - NJ Inst Food Nutrition & Health Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.