Weight LossTREMBONCT05548517
TRE: Microbiome, Metabolic Health and Bone
A study testing Time Restricted Eating (TRE) and Calorie Restriction in people with Weight Loss and Time Restricted Feeding, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on bone health, as well as body weight and the gut microbiota in older women who are overweight or obese. Read more about this study
- Who is it for?
- Ages 50 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Time Restricted Feeding, Bone Loss
- What is being tested?
- Time Restricted Eating (TRE) and Calorie Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (>2 years since last menses)
- Body mass index (25-45 kg/m2)
- Agree to be randomly assigned to consume food for ≤ 9 hours/day or ≥12 hours/day
- Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
Who cannot join
- Participants with >5% weight loss in the past 6 months or extreme dietary/physical activity habits
- An inability to follow the experimental intervention or to perform the required specimen collections
- Antibiotic use in the past 2 months
- Current diagnosis, or history of cancer in past 3 years
- History of surgical procedure for weight loss in the past 3 years
- Current diagnosis or history of bone diseases, type I or II diabetes, gastrointestinal disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease
Show all 13Show fewer
- Uncontrolled hypertension or hyperlipidemia in abnormal ranges
- Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
- A colonoscopy within the past 2 months
- Alcohol or illicit drug abuse
- Current smoker or having quit smoking in the past 3 months
- Shift work
- Participation in another clinical research trial which may interfere with the results of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University - NJ Inst Food Nutrition & Health
New Brunswick, New Jersey, 08901
About this study
Official title: Time Restricted Eating on the Microbiome Affecting Metabolic Health and Bone in Older Women
In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on bone health, as well as body weight and the gut microbiota in older women who are overweight or obese.
Read the detailed description
Time-restricted eating (TRE) has gained increased attention due to the possibility to induce weight loss and improve cardiometabolic health as a result of the purported alignment of circadian rhythm. However, since TRE is often reported to cause a spontaneous reduction of calories, it is not well understood if these health benefits are due to weight loss, circadian rhythm alignment, or a combination of the two. Furthermore, while weight loss can improve cardiometabolic health, it can also induce bone loss, which is problematic in older women who are at a higher risk of fracture. Interestingly, both bone turnover and the gut microbiota are responsive to diurnal variations, such as meal timing, and alterations in the gut microbiota have been associated with differences in bone health. In rodent models, caloric restriction can alter the gut microbiota composition with further alterations shown due to time-restricted eating. This suggests that time-restricted eating could affect bone health, which may be partially mediated by changes in the gut microbiota. Also, lifestyle patterns affects both the microbiota and bone. This randomized controlled trial will use behavior modification to examine TRE plus caloric restriction (CR) to achieve an evening energy deficit compared to CR alone on bone health, as well as body weight and the gut microbiota in older women who have overweight or obese.
- Conditions
- Weight Loss, Time Restricted Feeding, Bone Loss
- Being tested
- Time Restricted Eating (TRE), Calorie Restriction
- Keywords
- bone mineral density, Microbiome, obesity and overweight, metabolic health, time restricted feeding, energy restriction
- Medical subject headings
- Weight Loss, Intermittent Fasting, Bone Diseases, Metabolic, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted Eating (TRE)Behavioural
9-hour eating window
Calorie RestrictionBehavioural
daily calorie restriction
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating and calorie restriction | Experimental | 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). Receives: Behavioral: Time Restricted Eating (TRE); Behavioral: Calorie Restriction |
| Calorie restriction alone | Active comparator | 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. Receives: Behavioral: Calorie Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (BMD - hip)
dual energy x-ray absorptiometry
Measured: change from baseline to an average 6 months
Secondary outcomes (8)
Areal BMD (radius, lumbar spine)
dual energy x-ray absorptiometry
Measured: change from baseline to an average 6 months
Gut Microbiota
stool
Measured: change from baseline to an average 6 months
Weight loss
Body weight in kg
Measured: change from baseline to an average 6 months
Soft tissues
dual energy x-ray absorptiometry (lean, fat mass, visceral adipose tissue)
Measured: change from baseline to an average 6 months
Trabecular bone
peripheral quantitative computed tomography (volumetric BMD, bone volume / total volume, and separation)
Measured: Change from baseline to an average 6 months
Cortical (Ct) bone
peripheral quantitative computed tomography (Ct volumetric BMD, Ct thickness and porosity, and total BMD)
Measured: change from baseline to an average 6 months
Glucose - response to oral glucose tolerance test
fasting and response to glucose solution
Measured: change from baseline to an average 6 months
Insulin - response to oral glucose tolerance test
fasting and response to glucose solution
Measured: change from baseline to an average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start15 Oct 2022
- Primary completion15 Aug 2024
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial Enroll \~48 to achieve sample size of 40
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue A. Shapses, Ph.D., RD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548517
- Sponsor's protocol ID
- Pro2021002434
- Acronym
- TREMBO
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating on the Microbiome Affecting Metabolic Health and Bone in Older Women
- ClinicalTrials.gov ID
- NCT05548517
- Acronym / sponsor ID
- TREMBO / Pro2021002434
- Conditions
- Weight Loss, Time Restricted Feeding, Bone Loss
- Keywords
- bone mineral density, Microbiome, obesity and overweight, metabolic health, time restricted feeding, energy restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on bone health, as well as body weight and the gut microbiota in older women who are overweight or obese.
Detailed description
Time-restricted eating (TRE) has gained increased attention due to the possibility to induce weight loss and improve cardiometabolic health as a result of the purported alignment of circadian rhythm. However, since TRE is often reported to cause a spontaneous reduction of calories, it is not well understood if these health benefits are due to weight loss, circadian rhythm alignment, or a combination of the two. Furthermore, while weight loss can improve cardiometabolic health, it can also induce bone loss, which is problematic in older women who are at a higher risk of fracture. Interestingly, both bone turnover and the gut microbiota are responsive to diurnal variations, such as meal timing, and alterations in the gut microbiota have been associated with differences in bone health. In rodent models, caloric restriction can alter the gut microbiota composition with further alterations shown due to time-restricted eating. This suggests that time-restricted eating could affect bone health, which may be partially mediated by changes in the gut microbiota. Also, lifestyle patterns affects both the microbiota and bone. This randomized controlled trial will use behavior modification to examine TRE plus caloric restriction (CR) to achieve an evening energy deficit compared to CR alone on bone health, as well as body weight and the gut microbiota in older women who have overweight or obese.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial Enroll ~48 to achieve sample size of 40
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating and calorie restriction | Experimental | Behavioral: Time Restricted Eating (TRE), Behavioral: Calorie RestrictionSubjects 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). |
| Calorie restriction alone | Active comparator | Behavioral: Calorie RestrictionSubjects 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 may qualify
- Ages
- 50 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women (>2 years since last menses)
- Body mass index (25-45 kg/m2)
- Agree to be randomly assigned to consume food for ≤ 9 hours/day or ≥12 hours/day
- Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
Key exclusion criteria (13 listed)
- Participants with >5% weight loss in the past 6 months or extreme dietary/physical activity habits
- An inability to follow the experimental intervention or to perform the required specimen collections
- Antibiotic use in the past 2 months
- Current diagnosis, or history of cancer in past 3 years
- History of surgical procedure for weight loss in the past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted Eating (TRE)9-hour eating window | Behavioural | Time restricted eating and calorie restriction |
| Calorie Restrictiondaily calorie restriction | Behavioural | Calorie restriction alone, Time restricted eating and calorie restriction |
Primary outcome
Bone mineral density (BMD - hip)
Time frame: change from baseline to an average 6 months
dual energy x-ray absorptiometry
8 secondary outcomes
Areal BMD (radius, lumbar spine)
Time frame: change from baseline to an average 6 months
Gut Microbiota
Time frame: change from baseline to an average 6 months
Weight loss
Time frame: change from baseline to an average 6 months
Soft tissues
Time frame: change from baseline to an average 6 months
Trabecular bone
Time frame: Change from baseline to an average 6 months
Cortical (Ct) bone
Time frame: change from baseline to an average 6 months
Glucose - response to oral glucose tolerance test
Time frame: change from baseline to an average 6 months
Insulin - response to oral glucose tolerance test
Time frame: change from baseline to an average 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating (TRE) and Calorie Restriction in people with Weight Loss and Time Restricted Feeding, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (BMD - hip) (time frame: change from baseline to an average 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.