Early Time-Restricted Eating Combined With Exercise in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Time-Restricted Eating (eTRE)+Exercise Intervention.
- Who it may be relevant to
- Registry conditions: Nutrition, Health and Wellbeing, Aging, Time Restricted Eating. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Detailed description
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.
Interventions
- 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
Primary outcome measures
- Bone Mineral Density (BMD) [Time frame: Baseline and 6 months (pre-intervention and post-intervention)]
Secondary outcome measures (3)
- Gait performance [Time frame: Baseline and 6 months (pre-intervention and post-intervention)]
- Balance [Time frame: Baseline and 6 months (pre-intervention and post-intervention)]
- Fall Risk [Time frame: Baseline and 6 months (pre-intervention and post-intervention)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Tunisia · 1 center
- Manouba University — Manouba
Identifiers
NCT: NCT07695961 · ISSEP-2025-086