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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
Summary
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.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to an average 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to an average 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone mineral density (BMD - hip)
Microbiota
Weight loss
Secondary study objectives
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 moreOther study objectives
25-hydroxyvitamin D (25OHD)
6 minute walk test
Circumferences
+14 moreTrial 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.
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
435 Previous Clinical Trials
64,975 Total Patients Enrolled
2 Trials studying Weight Loss
35 Patients Enrolled for Weight Loss
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who has not had a menstrual period for over 2 years.My blood pressure or cholesterol levels are not under control.I regularly take medication that affects bone health, like bisphosphonates or hormone therapy.I have been diagnosed with cancer in the last 3 years.I have not taken antibiotics in the last 2 months.I had weight loss surgery within the last 3 years.I agree to follow a strict eating schedule as part of the study.I do not have a history of significant bone, diabetes, GI, thyroid, immune, liver, heart, or kidney diseases.You usually eat food for at least 14 hours every day.Your body weight relative to your height is within a certain range (25-39 kg/m2).
Research Study Groups:
This trial has the following groups:- Group 1: Calorie restriction alone
- Group 2: Time restricted eating and calorie restriction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Weight Loss Patient Testimony for trial: Trial Name: NCT05548517 — N/A
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