Time-Restricted Eating + Calorie Restriction for Weight Loss and Bone Health

(TREMBO Trial)

Recruiting at1 trial location

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a diet where older women who are overweight or obese eat only during certain times and reduce their calorie intake. The goal is to see if this helps them lose weight, improve heart health, and strengthen bones by changing gut bacteria.

Research Team

Eligibility Criteria

This trial is for postmenopausal women who are overweight or obese, with a BMI of 25-39 kg/m2 and eat over a span of at least 14 hours daily. They must be able to visit the site in New Brunswick, NJ without travel reimbursement. Women taking certain bone medications, those with recent significant weight loss or extreme diets, smokers, and those with various health conditions including uncontrolled hypertension cannot participate.

Inclusion Criteria

I am a woman who has not had a menstrual period for over 2 years.

Body mass index (25-45 kg/m2)

Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)

Exclusion Criteria

Shift work

Participation in another clinical research trial which may interfere with the results of this study

Alcohol or illicit drug abuse

Treatment Details

Interventions

• Calorie Restriction (Behavioral Intervention)
• Time Restricted Eating (TRE) (Behavioral Intervention)

Trial Overview The TREMBO study is testing if eating within a set time frame each day plus cutting calories helps older women lose weight better than just cutting calories alone. It also looks at how this might affect the good bacteria in their guts and their bone health.

Participant Groups

Group I: Time restricted eating and calorie restriction Experimental Treatment 2 Interventions

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).

Group II: Calorie restriction alone Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School