Early Time-Restricted Eating Combined With Exercise in Older Adults

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Early Time-Restricted Eating (eTRE)+Exercise Intervention
  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

Первичные конечные точки

• Bone Mineral Density (BMD) [Срок оценки: Baseline and 6 months (pre-intervention and post-intervention)]

Вторичные конечные точки (3)

• Gait performance [Срок оценки: Baseline and 6 months (pre-intervention and post-intervention)]
• Balance [Срок оценки: Baseline and 6 months (pre-intervention and post-intervention)]
• Fall Risk [Срок оценки: Baseline and 6 months (pre-intervention and post-intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Tunisia · 1 центр

• Manouba University — Manouba

Идентификаторы

NCT: NCT07695961 · ISSEP-2025-086

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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