NCT07824375

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (2)

  • Bone mineral density

    measured by dual-energy X-ray absorptiometry

    Baseline and 12 weeks

  • Bone mineral content

    measured by dual-energy X-ray absorptiometry

    Baseline and 12 weeks

Study Arms (2)

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.

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.

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

Interventions

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.

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

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

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations

US(1)