Early Time-Restricted Eating Combined With Exercise in Older Adults

July 5, 2026 updated by: Maha Gasmi, University of Manouba

Effects of Early Time-Restricted Eating Combined With a Multicomponent Exercise Program on Bone Mineral Density, Gait, Balance, and Fall Risk in Healthy Older Adults: A Randomized Controlled Trial.

This randomized controlled trial aims to investigate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone health, physical function, and fall risk in healthy older adults.

A total of approximately 44 healthy adults aged 60 years and older will be recruited and randomly assigned to one of two groups. The experimental group will follow an Early Time-Restricted Eating schedule (07:00-15:00 eating window ) combined with a structured multicomponent exercise program. The control group will not receive any dietary timing intervention or structured exercise program and will continue their usual daily lifestyle.

The intervention will last for 6 months. Participants in the exercise program will perform supervised sessions including resistance training, balance exercises, aerobic activity, and flexibility exercises. The Early Time-Restricted Eating protocol will involve consuming all daily food intake within an early daytime window while maintaining usual dietary quality and adequate energy and nutrient intake.

The main outcomes of the study include changes in bone mineral density, gait performance, balance, and fall risk. These outcomes will be measured at baseline and after the intervention period.

This study will provide evidence on whether combining early time-restricted eating with structured exercise can improve musculoskeletal health and functional ability, and reduce fall risk in older adults.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial aims to determine the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone mineral density, physical function, and fall risk in healthy older adults.

Healthy adults aged 60 years and older will be recruited and randomly assigned to either an experimental group or a control group using a 1:1 randomization procedure.

Eligible participants will be sedentary or moderately active, with stable body weight during the previous 3 months, and without metabolic, musculoskeletal, or neurological conditions that may affect study outcomes. Participants using osteoporosis medication, presenting severe sarcopenia, cognitive impairment, or chronic diseases affecting bone or metabolism will be excluded.

The intervention will last 6 months. The experimental group will participate in a supervised multicomponent exercise program performed three times per week, with each session lasting approximately 60 minutes. The exercise program will include resistance training (20-25 minutes at 60-80% of one-repetition maximum), balance exercises (10-15 minutes including static and dynamic tasks), aerobic training (15-20 minutes at moderate intensity corresponding to 50-70% of maximal heart rate), and flexibility exercises (5-10 minutes).

In addition to the exercise program, the experimental group will follow an Early Time-Restricted Eating protocol. Participants will consume all daily caloric intake within an 8-hour window (e.g., 07:00 to 15:00), followed by a 16-hour fasting period. Water intake will be permitted ad libitum during fasting hours. Participants will be instructed to maintain adequate energy intake and consume at least 1.2 g/kg/day of protein, distributed evenly across 2-3 meals within the feeding window. Dietary intake will be monitored using food diaries and supervised by a dietitian.

Exercise sessions will be scheduled within the eating window to optimize energy availability and recovery.

Primary outcome measure will be bone mineral density assessed by dual-energy X-ray absorptiometry (DXA). Secondary outcomes will include gait performance (e.g., 4-meter gait speed test), balance (e.g., Berg Balance Scale or one-leg stance test), fall risk (Timed Up and Go test).

Assessments will be conducted at baseline and after the 6-month intervention period. Data will be analyzed using two-way repeated measures analysis of variance (Group × Time), with post hoc tests as appropriate. Statistical significance will be set at p < 0.05.

Study Type

Interventional

Enrollment (Estimated)

44

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 Contact

Study Contact Backup

Study Locations

  • Tunisia
    • Manouba
      • Manouba, Manouba, Tunisia
        • Manouba University

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

Yes

Description

Inclusion Criteria:

  • Aged 60 years or older
  • Community-dwelling and generally healthy older adults
  • Sedentary or moderately physically active
  • Stable body weight during the previous 3 months (no intentional weight loss or gain >5%)
  • Able to participate in a supervised exercise program
  • Willing to comply with the time-restricted eating protocol and study procedures
  • Able to provide written informed consent

Exclusion Criteria:

  • Diagnosis of osteoporosis requiring pharmacological treatment
  • Severe sarcopenia or major mobility limitations preventing safe exercise participation
  • Cognitive impairment or diagnosed dementia affecting ability to follow instructions
  • Presence of uncontrolled chronic diseases affecting bone metabolism (e.g., advanced renal disease, uncontrolled endocrine disorders)
  • Current use of medications affecting bone metabolism (e.g., corticosteroids, anti-osteoporotic drugs)
  • Participation in another structured exercise or dietary intervention program within the past 3 months
  • Any medical condition that contraindicates moderate-intensity exercise
  • Inability to comply with study protocol or follow-up assessments

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Time-Restricted Eating (eTRE)+Exercise Intervention Group
Participants in the experimental group will follow a 16:8 Early Time-Restricted Eating protocol combined with a supervised multicomponent exercise program for 6 months. The exercise program includes resistance, aerobic, balance, and flexibility training, while the eating window is restricted to 8 hours per day with adequate energy and protein intake maintained.
Behavioral: Early Time-Restricted Eating (eTRE)+Exercise Intervention
Participants will follow an Early Time-Restricted Eating protocol consisting of a 16:8 fasting-feeding schedule. All daily caloric intake will be consumed within an 8-hour window (e.g., 07:00-15:00), followed by a 16-hour fasting period. Participants will be instructed to maintain adequate energy intake and consume at least 1.2 g/kg/day of protein, distributed across meals within the eating window. Water intake will be allowed ad libitum during fasting hours. A supervised multicomponent exercise program including resistance, aerobic, balance, and flexibility training. Sessions will be performed three times per week for 6 months. Resistance training will be performed at 60-80% of one-repetition maximum, aerobic training at moderate intensity (50-70% of maximum heart rate), and balance and flexibility exercises will be included in each session to improve functional capacity in older adults.
No Intervention: Control
Participants in the control group will not receive any structured exercise program or dietary timing intervention and will be instructed to maintain their habitual diet and physical activity throughout the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD)
Time Frame: Baseline and 6 months (pre-intervention and post-intervention)
Bone mineral density (BMD) will be assessed using dual-energy X-ray absorptiometry (DXA) at baseline and after the 6-month intervention period. BMD measurements will be used to evaluate changes in bone health in response to the intervention in older adults.
Baseline and 6 months (pre-intervention and post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait performance
Time Frame: Baseline and 6 months (pre-intervention and post-intervention)
Gait performance will be assessed using a standardized 4-meter gait speed test at baseline and after the 6-month intervention period. Participants will be instructed to walk at their usual pace, and gait speed will be used as an indicator of functional mobility and physical performance in older adults.
Baseline and 6 months (pre-intervention and post-intervention)
Balance
Time Frame: Baseline and 6 months (pre-intervention and post-intervention)
Balance will be assessed using the Berg Balance Scale or a one-leg stance test at baseline and after the 6-month intervention period. These tests will evaluate static and dynamic balance ability in older adults and will be used to determine changes in postural stability following the intervention.
Baseline and 6 months (pre-intervention and post-intervention)
Fall Risk
Time Frame: Baseline and 6 months (pre-intervention and post-intervention)
Fall risk will be assessed using the Timed Up and Go (TUG) test at baseline and after the 6-month intervention period. The TUG test measures the time required to stand up from a chair, walk 3 meters, turn, return, and sit down, and is used as an indicator of functional mobility and fall risk in older adults.
Baseline and 6 months (pre-intervention and post-intervention)

Collaborators and Investigators

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

Sponsor

University of Manouba

Collaborators

Faculty of Medicine, Sousse

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)

June 15, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 5, 2026

First Submitted That Met QC Criteria

July 5, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSEP-2025-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.

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.

Clinical Trials on Aging

Clinical Trials on Early Time-Restricted Eating (eTRE)+Exercise Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe