CompletedNot Applicable

TRE: Microbiome, Metabolic Health and Bone

United States49 participantsStarted 2022-10-15

Plain-language summary

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.

Who can participate

Age range

50 Years – 79 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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 * Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement. * A colonoscopy within the past 2 months * Alcohol or illicit drug abuse * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bone mineral density (BMD - hip)

Timeframe: change from baseline to an average 6 months

Trial details

NCT IDNCT05548517

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Weight Loss trials