Early Time-Restricted Eating Combined With Exercise in Older Adults (NCT07695961) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Time-Restricted Eating Combined With Exercise in Older Adults
Tunisia44 participantsStarted 2026-06-15
Plain-language 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.
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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone Mineral Density (BMD)
Timeframe: Baseline and 6 months (pre-intervention and post-intervention)