Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07824375

Time-Restricted Eating and Exercise for Bone Health

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Bone mineral density

    Time frame: Baseline and 12 weeks

    measured by dual-energy X-ray absorptiometry

  2. Bone mineral content

    Time frame: Baseline and 12 weeks

    measured by dual-energy X-ray absorptiometry

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

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

Registry information

Official study title

Time-Restricted Eating and Exercise Training to Enhance Bone Health in Adults With Osteopenia

Acronym: OSTEO-FIT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.