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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

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
429 Previous Clinical Trials
64,184 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this clinical trial for participants?

"Affirmative. Clinicaltrials.gov evidences that this medical study, first created on October 15th 2022, is still in the process of seeking participants. The project requires 50 volunteers from 2 distinct treatment centres to be enrolled."

Answered by AI

How many participants is the research team enrolling in this experiment?

"Affirmative. The clinical trial registry reports that this research, initially posted on October 15th 2022, is actively trying to recruit participants. A total of 50 people are needed from two distinct medical centres."

Answered by AI

Are geriatric patients included in the eligibility criteria for this clinical experiment?

"The cutoff for this medical trial is 50 years old, with no upper age limit. In contrast to that, there are 21 trials specifically designed for participants under 18 and 198 studies meant for patients over 65."

Answered by AI

What are the expected outcomes of this research endeavor?

"The primary endpoint of this experiment is to assess changes in Bone Mineral Density (BMD - hip) from baseline over a period of 6 months. Secondary objectives include evaluating Cortical bone structure via peripheral quantitative computed tomography, measuring Blood Pressure with sphygmomanometer readings, and Glucose response to an Oral Glucose Tolerance Test which involves fasting and ingesting glucose-containing solutions."

Answered by AI

Are there openings available to join this medical experiment?

"The ideal participants of this trial are postmenopausal women with alopecia aged between 50 and 79. There is an additional requirement that their body mass index should be 25-39 kg/m2, as well as a diet consisting of food consumed for at least 14 hours each day."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
California
New York
Other
How old are they?
18 - 65
What site did they apply to?
Sue A Shapses
Rutgers University - NJ Inst Food Nutrition & Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

The help with weight loss. Looking for a working option. Being obese is affecting my health.
PatientReceived no prior treatments
I have tried many methods, diets. Nothing works for me. I want to join a trial and see if that helps.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does the study take? Is it dangerous? Does it require medication? How much does the study pay?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
TRE: Microbiome, Metabolic Health and Bone
Sue A. Shapses, Ph.D., RD 2022. "TRE: Microbiome, Metabolic Health and Bone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05548517.
All > Osteoporosis Philadelphia > Osteoporosis
~9 spots leftby Sep 2024
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