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| Name | Class |
|---|---|
| Faculty of Medicine, Sousse | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Time-Restricted Eating (eTRE)+Exercise Intervention Group | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Gait performance | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha Gasmi, PhD | Contact | +21699040701 | mahagasmi@hotmail.fr | |
| Kawther Missawi, PhD | Contact | +21697323721 | kawther.missawi@hotmail.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manouba University | Manouba | Manouba | Tunisia |
There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Participants will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The study will follow a parallel design, with both groups participating simultaneously over a 6-month intervention period. The experimental group will follow a 16:8 time-restricted eating and exercise protocol, while the control group will maintain their habitual dietary practices.
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| Balance | 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 | 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) |