TRE: Microbiome, Metabolic Health and Bone (NCT05548517) | Clinical Trial Compass
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 range50 Years – 79 Years
SexFEMALE
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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.
What they're measuring
1
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