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

N/A
Recruiting
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to an average 6 months
Awards & highlights

TREMBO Trial Summary

This trial will study the effect of time-restricted eating and calorie restriction on body weight, gut bacteria, and bone health in overweight/obese older women.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from participating may include feelings of hunger due to calorie restriction and changes in energy levels or mood related to new eating patterns.

TREMBO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to an average 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to an average 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone mineral density (BMD - hip)
Microbiota
Weight loss
Secondary outcome measures
Areal BMD (lumbar spine, femoral neck, radius, total body)
Blood pressure (systolic and diastolic)
Cortical bone (volumetric BMD, thickness, and porosity) and total BMD
+4 more
Other outcome measures
25-hydroxyvitamin D (25OHD)
6 minute walk test
Circumferences
+14 more

TREMBO Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calorie Restriction
2015
N/A
~480
Time Restricted Eating (TRE)
2020
N/A
~120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Time-restricted eating (TRE) is a weight loss strategy that involves limiting food intake to specific hours of the day, which can improve metabolic health by aligning eating patterns with the body's circadian rhythms. This approach can enhance insulin sensitivity, reduce appetite, and promote fat loss. Additionally, TRE may positively influence the gut microbiota by fostering a more balanced microbial environment, which can further support metabolic health. For weight loss patients, these mechanisms are crucial as they not only aid in reducing body weight but also improve overall metabolic function and potentially bone health, making TRE a holistic approach to weight management.
Linking the Gut Microbiota to Bone Health in Anorexia Nervosa.

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
434 Previous Clinical Trials
64,875 Total Patients Enrolled
2 Trials studying Weight Loss
35 Patients Enrolled for Weight Loss

Media Library

Calorie Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05548517 — N/A
Weight Loss Research Study Groups: Calorie restriction alone, Time restricted eating and calorie restriction
Weight Loss Clinical Trial 2023: Calorie Restriction Highlights & Side Effects. Trial Name: NCT05548517 — N/A
Calorie Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548517 — N/A
Weight Loss Patient Testimony for trial: Trial Name: NCT05548517 — N/A
~4 spots leftby Sep 2024