Time-Restricted Eating and Exercise for Bone Health (OSTEO-FIT)

September 11, 2026 updated by: Yi Lin, University of Alabama at Birmingham

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: Baseline and 12 weeks
measured by dual-energy X-ray absorptiometry
Baseline and 12 weeks
Bone mineral content
Time Frame: Baseline and 12 weeks
measured by dual-energy X-ray absorptiometry
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

UAB Center for Exercise Medicine
UAB Comprehensive Arthritis, Musculoskeletal, Bone and Autoimmunity Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300017177
  • UCEM-CAMBAC Joint Pilot Grant (Other Grant/Funding Number: The University of Alabama at Birmingham)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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