Early Time-Restricted Eating Combined With Exercise in Older Adults

NCT07695961 | Not Yet Recruiting

• 1 other identifier: ISSEP-2025-086
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health and Wellbeing; Aging; Nutrition; Time Restricted Eating; Bone Health

Keywords

Time Restricted Eating; Exercise Program; Bone Mineral Density; Gait; Balance

Outcome Measures

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.

  Baseline and 6 months (pre-intervention and post-intervention)

Secondary Outcomes (3)

• Gait performance

  Baseline and 6 months (pre-intervention and post-intervention)

• Balance

  Baseline and 6 months (pre-intervention and post-intervention)

• Fall Risk

  Baseline and 6 months (pre-intervention and post-intervention)

Study Arms (2)

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.

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.

Interventions

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.

Early Time-Restricted Eating (eTRE)+Exercise Intervention Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: collaborator
• University of Manouba: lead

Study Sites (1)

Manouba University

Manouba, Manouba, Tunisia

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Central Study Contacts

Maha Gasmi, PhD

CONTACT

+21699040701; mahagasmi@hotmail.fr

Kawther Missawi, PhD

CONTACT

+21697323721; kawther.missawi@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)