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NCT Number: NCT07695961

Early Time-Restricted Eating Combined With Exercise in Older Adults

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 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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manouba University

Manouba, Tunisia

About this study

This randomized controlled trial is designed to evaluate 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.

Participants will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The intervention will last for 6 months. The experimental group will follow an Early Time-Restricted Eating protocol, consisting of an 8-hour daily eating window (e.g., 07:00-15:00) followed by a 16-hour fasting period, in combination with a supervised multicomponent exercise program performed three times per week.

Each exercise session will last approximately 60 minutes and will include resistance training, balance exercises, aerobic activities, and flexibility exercises. Exercise sessions will be scheduled within the eating window to optimize energy availability and recovery. Dietary intake will be monitored to ensure adequate energy and protein consumption.

The control group will maintain their usual lifestyle without any structured dietary timing or exercise intervention.

Assessments will be conducted at baseline and after the intervention period. Data will be analyzed using repeated measures analysis to evaluate the effects of time, group, and their interaction on study outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Early Time-Restricted Eating (eTRE)+Exercise Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kawther Missawi, PhD

CONTACT

[email protected]

+21697323721

Maha Gasmi, PhD

CONTACT

[email protected]

+21699040701

Sponsors and collaborators

Lead sponsor

University of Manouba

Other

Collaborators

  • Faculty of Medicine, Sousse

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 13, 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.

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