TRE: Microbiome, Metabolic Health and Bone

NCT05548517 | Completed

• 1 other identifier: Pro2021002434
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss; Time Restricted Feeding; Bone Loss

Keywords

bone mineral density; Microbiome; obesity and overweight; metabolic health; time restricted feeding; energy restriction

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (BMD - hip)

  dual energy x-ray absorptiometry

  change from baseline to an average 6 months

Secondary Outcomes (8)

• Areal BMD (radius, lumbar spine)

  change from baseline to an average 6 months

• Gut Microbiota

  change from baseline to an average 6 months

• Weight loss

  change from baseline to an average 6 months

• Soft tissues

  change from baseline to an average 6 months

• Trabecular bone

  Change from baseline to an average 6 months

Other Outcomes (20)

• Fasting osteocalcin

  change from baseline to an average 6 months

• Fasting procollagen type 1 N-terminal propeptide (PINP)

  change from baseline to an average 6 months

• Fasting C-telopeptide of type I collagen (CTX)

  change from baseline to an average 6 months

Study Arms (2)

Time restricted eating and calorie restriction

EXPERIMENTAL

Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. In addition, they will be asked to only consume calories during a 9-hour window (15:9).

Behavioral: Time Restricted Eating (TRE); Behavioral: Calorie Restriction

Calorie restriction alone

ACTIVE COMPARATOR

Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. They will be advised to continue to consume foods throughout the day and into the evening.

Behavioral: Calorie Restriction

Interventions

Time Restricted Eating (TRE) BEHAVIORAL

9-hour eating window

Time restricted eating and calorie restriction

Calorie Restriction BEHAVIORAL

daily calorie restriction

Calorie restriction alone; Time restricted eating and calorie restriction

Eligibility Criteria

• Age: 50 Years - 79 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University - NJ Inst Food Nutrition & Health

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Weight Loss; Intermittent Fasting; Bone Diseases, Metabolic; Obesity; Overweight

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial Enroll \~48 to achieve sample size of 40

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: October 15, 2022
• Primary Completion: August 15, 2024
• Study Completion: September 15, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)