Time-Restricted Eating + Calorie Restriction for Weight Loss and Bone Health (TREMBO Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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.

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.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Time restricted eating and calorie restrictionExperimental Treatment2 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 aloneActive Control1 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.