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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Early Time-Restricted Eating (eTRE)+Exercise Intervention (Behavioral)
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.
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: Baseline and 6 months (pre-intervention and post-intervention)
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.
次要结局
- 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))
研究者
Maha Gasmi
Researcher
University of Manouba