Early Time-Restricted Eating Combined With Exercise in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversity of Manouba
About this 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.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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%)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Early Time-Restricted Eating (eTRE)+Exercise Intervention
BehavioralParticipants 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Early Time-Restricted Eating (eTRE)+Exercise Intervention GroupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 months (pre-intervention and post-intervention)Secondary outcomes
1
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.
Time frame
Baseline and 6 months (pre-intervention and post-intervention)2
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.
Time frame
Baseline and 6 months (pre-intervention and post-intervention)3
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.
Time frame
Baseline and 6 months (pre-intervention and post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manouba
Lead sponsor
Faculty of Medicine, Sousse
Collaborator
Source ClinicalTrials.gov
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