NutritionNCT07695961
Early Time-Restricted Eating Combined With Exercise in Older Adults
A study testing Early Time-Restricted Eating (eTRE)+Exercise Intervention in people with Nutrition and Health and Wellbeing, run by University of Manouba at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Health and Wellbeing, Aging
- What is being tested?
- Early Time-Restricted Eating (eTRE)+Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Nutrition, Health and Wellbeing, Aging, Time Restricted Eating, Bone Health
- Being tested
- Early Time-Restricted Eating (eTRE)+Exercise Intervention
- Keywords
- Time Restricted Eating, Exercise Program, Bone Mineral Density, Gait, Balance
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted Eating (eTRE)+Exercise InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Early Time-Restricted Eating (eTRE)+Exercise Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months (pre-intervention and post-intervention)
Secondary outcomes (3)
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.
Measured: Baseline and 6 months (pre-intervention and post-intervention)
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.
Measured: 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.
Measured: Baseline and 6 months (pre-intervention and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manouba
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine, Sousse
- Responsible party
- Principal investigator, Maha Gasmi, University of Manouba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695961
- Sponsor's protocol ID
- ISSEP-2025-086
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07695961
- Acronym / sponsor ID
- ISSEP-2025-086
- Conditions
- Nutrition, Health and Wellbeing, Aging, Time Restricted Eating, Bone Health
- Keywords
- Time Restricted Eating, Exercise Program, Bone Mineral Density, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ManoubaUniversity, hospital or other
- Collaborators
- Faculty of Medicine, Sousse
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Time-Restricted Eating (eTRE)+Exercise Intervention Group | Experimental | Behavioral: Early Time-Restricted Eating (eTRE)+Exercise InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Time-Restricted Eating (eTRE)+Exercise InterventionParticipants 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. | Behavioural | Early Time-Restricted Eating (eTRE)+Exercise Intervention Group |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data. Only aggregate study results will be reported in publications and presentations.
Related trials for Nutrition
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Eating (eTRE)+Exercise Intervention in people with Nutrition and Health and Wellbeing, run by University of Manouba at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Gasmi, PhD (+21699040701, mahagasmi@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: Baseline and 6 months (pre-intervention and post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.