Early Time-Restricted Eating Combined With Exercise in Older Adults
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maha Gasmi, PhD
- Número de teléfono: +21699040701
- Correo electrónico: mahagasmi@hotmail.fr
Copia de seguridad de contactos de estudio
- Nombre: Kawther Missawi, PhD
- Número de teléfono: +21697323721
- Correo electrónico: kawther.missawi@hotmail.fr
Ubicaciones de estudio
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Manouba
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Manouba, Manouba, Túnez
- Manouba University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Early Time-Restricted Eating (eTRE)+Exercise Intervention Group
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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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.
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Sin intervención: Control
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Bone Mineral Density (BMD)
Periodo de tiempo: Baseline and 6 months (pre-intervention and post-intervention)
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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.
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Baseline and 6 months (pre-intervention and post-intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Gait performance
Periodo de tiempo: Baseline and 6 months (pre-intervention and post-intervention)
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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.
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Baseline and 6 months (pre-intervention and post-intervention)
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Balance
Periodo de tiempo: Baseline and 6 months (pre-intervention and post-intervention)
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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.
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Baseline and 6 months (pre-intervention and post-intervention)
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Fall Risk
Periodo de tiempo: Baseline and 6 months (pre-intervention and post-intervention)
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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.
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Baseline and 6 months (pre-intervention and post-intervention)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ISSEP-2025-086
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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