OsteopeniaOSTEO-FITNCT07824375
Time-Restricted Eating and Exercise for Bone Health
A study testing Time-restricted eating combined with resistance exercise (TRE+Ex) and Habitual eating pattern combined with resistance exercise (HE+Ex) in people with Osteopenia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to learn whether combining time-restricted eating with supervised resistance exercise can improve bone health in adults with osteopenia. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteopenia
- What is being tested?
- Time-restricted eating combined with resistance exercise (TRE+Ex) and Habitual eating pattern combined with resistance exercise (HE+Ex)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 50-75 years with body mass index (BMI) >25kg/m2
- Osteopenia, defined as a T score between -1.0 and -2.5 at the lumbar spine, femoral neck, or total hip
- Elevated adiposity, defined by waist circumference >102 cm in men or >88 cm in women
- Stable health history over the past 2 months
- Stable medication history over the past 2 months, as recommended by the primary provider
- Willing and able to provide informed consent
Who cannot join
- Participation in a formal weight loss program, intentional caloric restriction, fasting >10 hours/day, or ≥10 pounds weight loss within the past 3 months
- Current participation in structured exercise training, supervised rehabilitation, or >150 minutes/week of moderate intensity physical activity
- Medical conditions or use of medications affecting bone metabolism
- Diagnosed diabetes or use of insulin or glucose lowering medications
- Resting heart rate >120 beats/minute or daytime blood pressure ≥180/100 mmHg
- Unstable angina, myocardial infarction, or stroke within the past 3 months
Show all 11Show fewer
- Continuous supplemental oxygen use for chronic pulmonary disease or heart failure
- Rheumatoid arthritis, Parkinson's disease, dialysis, active cancer treatment within the past year, or diagnosed cognitive impairment
- Absolute contraindications to exercise training according to American College of Sports Medicine guidelines
- Unable to fast for 16 hours
- Any condition that in the opinion of the investigator would impair ability to participate in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Yi Lin, PhD, 205.996.5876, yilin@uabmc.edu
About this study
Official title: Time-Restricted Eating and Exercise Training to Enhance Bone Health in Adults With Osteopenia
The purpose of this study is to learn whether combining time-restricted eating with supervised resistance exercise can improve bone health in adults with osteopenia.
- Conditions
- Osteopenia
- Being tested
- Time-restricted eating combined with resistance exercise (TRE+Ex), Habitual eating pattern combined with resistance exercise (HE+Ex)
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eating combined with resistance exercise (TRE+Ex)Behavioural
Participants in the TRE+Ex group will be asked to fast for a target of 16 hours per day, consuming food ad libitum within an 8-hour eating window beginning between 6:30 and 9:30 AM, 6 days per week for 12 weeks. They will also complete supervised progressive resistance exercise training 3 days per week.
Habitual eating pattern combined with resistance exercise (HE+Ex)Behavioural
Participants in the HE+Ex group will be instructed to maintain their habitual eating patterns and complete supervised progressive resistance exercise training 3 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating combined with resistance exercise (TRE+Ex) | Experimental | Participants in the TRE+Ex group will be asked to fast for a target of 16 hours per day, consuming food ad libitum within an 8-hour eating window beginning between 6:30 and 9:30 AM, 6 days per week for 12 weeks. They will also complete supervised progressive resistance exercise training 3 days per week. Receives: Behavioral: Time-restricted eating combined with resistance exercise (TRE+Ex) |
| Habitual eating pattern combined with resistance exercise (HE+Ex) | Active comparator | Participants in the HE+Ex group will be instructed to maintain their habitual eating patterns and complete supervised progressive resistance exercise training 3 days per week. Receives: Behavioral: Habitual eating pattern combined with resistance exercise (HE+Ex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
measured by dual-energy X-ray absorptiometry
Measured: Baseline and 12 weeks
Bone mineral content
measured by dual-energy X-ray absorptiometry
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- UAB Center for Exercise Medicine, UAB Comprehensive Arthritis, Musculoskeletal, Bone and Autoimmunity Center
- Responsible party
- Principal investigator, Yi Lin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824375
- Sponsor's protocol ID
- IRB-300017177
- Other IDs
- UCEM-CAMBAC Joint Pilot Grant
- Acronym
- OSTEO-FIT
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to concerns regarding participant privacy and the sensitive nature of the health-related data collected.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating and Exercise Training to Enhance Bone Health in Adults With Osteopenia
- ClinicalTrials.gov ID
- NCT07824375
- Acronym / sponsor ID
- OSTEO-FIT / IRB-300017177
- Conditions
- Osteopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- UAB Center for Exercise Medicine, UAB Comprehensive Arthritis, Musculoskeletal, Bone and Autoimmunity Center
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 17 Sep 2026 (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.
The purpose of this study is to learn whether combining time-restricted eating with supervised resistance exercise can improve bone health in adults with osteopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating combined with resistance exercise (TRE+Ex) | Experimental | Behavioral: Time-restricted eating combined with resistance exercise (TRE+Ex)Participants in the TRE+Ex group will be asked to fast for a target of 16 hours per day, consuming food ad libitum within an 8-hour eating window beginning between 6:30 and 9:30 AM, 6 days per week for 12 weeks. They will also complete supervised progressive resistance exercise training 3 days per week. |
| Habitual eating pattern combined with resistance exercise (HE+Ex) | Active comparator | Behavioral: Habitual eating pattern combined with resistance exercise (HE+Ex)Participants in the HE+Ex group will be instructed to maintain their habitual eating patterns and complete supervised progressive resistance exercise training 3 days per week. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 50-75 years with body mass index (BMI) >25kg/m2
- Osteopenia, defined as a T score between -1.0 and -2.5 at the lumbar spine, femoral neck, or total hip
- Elevated adiposity, defined by waist circumference >102 cm in men or >88 cm in women
- Stable health history over the past 2 months
- Stable medication history over the past 2 months, as recommended by the primary provider
Key exclusion criteria (11 listed)
- Participation in a formal weight loss program, intentional caloric restriction, fasting >10 hours/day, or ≥10 pounds weight loss within the past 3 months
- Current participation in structured exercise training, supervised rehabilitation, or >150 minutes/week of moderate intensity physical activity
- Medical conditions or use of medications affecting bone metabolism
- Diagnosed diabetes or use of insulin or glucose lowering medications
- Resting heart rate >120 beats/minute or daytime blood pressure ≥180/100 mmHg
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 combined with resistance exercise (TRE+Ex)Participants in the TRE+Ex group will be asked to fast for a target of 16 hours per day, consuming food ad libitum within an 8-hour eating window beginning between 6:30 and 9:30 AM, 6 days per week for 12 weeks. They will also complete supervised progressive resistance exercise training 3 days per week. | Behavioural | Time-restricted eating combined with resistance exercise (TRE+Ex) |
| Habitual eating pattern combined with resistance exercise (HE+Ex)Participants in the HE+Ex group will be instructed to maintain their habitual eating patterns and complete supervised progressive resistance exercise training 3 days per week. | Behavioural | Habitual eating pattern combined with resistance exercise (HE+Ex) |
Primary outcome
Bone mineral density
Time frame: Baseline and 12 weeks
measured by dual-energy X-ray absorptiometry
Bone mineral content
Time frame: Baseline and 12 weeks
measured by dual-energy X-ray absorptiometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to concerns regarding participant privacy and the sensitive nature of the health-related data collected.
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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.
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 combined with resistance exercise (TRE+Ex) and Habitual eating pattern combined with resistance exercise (HE+Ex) in people with Osteopenia, run by University of Alabama at Birmingham 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 17 Sep 2026.