ClinicalTrials.gg
Not yet recruitingNCT07824375OSTEO-FITUpdated Sep 17, 2026

Time-Restricted Eating and Exercise for Bone Health

An interventional study of Time-restricted eating combined with resistance exercise (TRE+Ex) and Habitual eating pattern combined with resistance exercise (HE+Ex) in Osteopenia, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 217 studies in Bone Diseases, Metabolic with a site in United States — 16 open to participants now, 21 under way, 1 of them phase 3. Bone Diseases, Metabolic · United States.

Planned enrollment
128th of 171
24 · median 66
Started
2026
with 3 others
No phase
57 of 217
6 open now
Primary completion
2027-12
later than 9 of 20 live
Registered
217th of 217
by date

Among the 217 studies in Bone Diseases, Metabolic with a site in United States, this one is the 128th largest by planned enrollment of the 171 interventional ones that give a count, is one of 4 that started in 2026, is one of 57 with no phase, reaches primary completion later than 9 of the 20 other live ones, and was the 217th registered.

Bone Diseases, Metabolic

661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.

Browse Bone Diseases, Metabolic studies →

Open to participants now

16 of the 217 studies in Bone Diseases, Metabolic with a site in United States are open now. Recruiting first, the newest first:

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All 16 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 63 Bone Diseases, Metabolic studies recruiting now, 27 (43%) set no upper age limit and 28 (44%) stop at 75 or younger; 12 take children under 18; 22 take healthy volunteers.

This study: 50 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Osteopenia
04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women aged 50-75 years with (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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Time-restricted eating combined with resistance exercise (TRE+Ex)

  • Active comparator
    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.

    Behavioral: Habitual eating pattern combined with resistance exercise (HE+Ex)

Interventions

  • BehavioralTime-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.

  • BehavioralHabitual 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.

06

What researchers measure

Primary outcomes

  1. Bone mineral density

    measured by dual-energy X-ray absorptiometry

    Time frame: Baseline and 12 weeks

  2. Bone mineral content

    measured by dual-energy X-ray absorptiometry

    Time frame: Baseline and 12 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — IPD may not be shared due to concerns regarding participant privacy and the sensitive nature of the health-related data collected.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

Of 161 non-industry interventional studies with no phase under Bone Diseases, Metabolic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 13 months is below that.

Counting every sponsor, half of 177 studies reached it within 22 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 17, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Apr 30, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07824375
Collaborators
UAB Center for Exercise Medicine, UAB Comprehensive Arthritis, Musculoskeletal, Bone and Autoimmunity Center
Responsible party
Yi Lin (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Sep 17, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Sep 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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