The Effects of Time-restricted Eating (TRE) With and Without Additional Protein on Body Composition, Muscle Function and Markers of Metabolic Health in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA)
研究概览
简要总结
The aim this study is to investigate the effects of time-restricted eating (TRE) on body composition, muscle function and markers of metabolic health of adults over 60 years old. This study will compare different variations of TRE - with and without an additional protein.
This study involves attending two study days at the University of Surrey for baseline and end-of-intervention measurement of body composition using a gold-standard dual energy x-ray absorptiometry (DEXA) scan; muscle function using hand grip strength and 30-second sit-to-stand tests; weight. A blood sample will be taken at each study visit to measure markers of lipid and glucose control, and insulin sensitivity.
Participants will be randomly allocated to one of four study groups:
- control group: maintain habitual dietary patterns
- TRE group: fast for 16 hours overnight, eat between 12-8pm
- TRE + Protein (AM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the morning
- TRE + Protein (PM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the afternoon Participants will be asked to follow the intervention according to their allocated group for 8 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: male and female
- •Age range: 60 years or older
- •Fasting for 12 or less hours on a daily basis
- •BMI range: 23-30 kg/m2
- •Weight stability: no more than 3kg weight gain or loss in the past 3 months
- •Regular eating pattern, i.e. 3 meals a day
- •Able to prepare the protein supplement
排除标准
- •Any of the following present (in line with exclusion criteria used in previous TRE research in older adults):
- •known renal impairment
- •heart attack or stroke in the past three months
- •continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
- •rheumatoid arthritis
- •Parkinson's disease
- •active treatment for cancer in the past year
- •insulin dependent diabetes mellitus
- •taking medications that preclude fasting for 16 h
- •actively trying or planning to lose weight
- •history of an eating disorder
- •outside of stated age or BMI range
- •fasting for longer than 12 hours on a daily basis
- •unable to prepare the protein supplement
- •extreme morning/evening chronotype
- •sleep disorders
- •regular meal skipping
- •history of difficulty having a blood sample taken
- •Recent exposure to high-dose radiation
- •Vigorous exercise on more than 3 occasions a week
结局指标
主要结局
Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA)
时间窗: For 8 weeks of the assigned study intervention
Measured using whole-body dual-energy x-ray absorptiometry (DEXA) In addition to the above, body composition will also be assessed using Tanita Bioelectrical impedance analysis (BIA). Fat free and fat mass will be reported in kg.
Change from baseline in muscle function at 2 months
时间窗: At the start and end of 8 weeks of the assigned study intervention
Measured using grip strength
次要结局
- Change in fasting glucose control indicators(At the start and end of 8 weeks of the assigned study intervention)
- Change from baseline in insulin sensitivity at 2 months(At the start and end of 8 weeks of the assigned study intervention)
- Change from baseline in lipid metabolism at 2 months(At the start and end of 8 weeks of the assigned study intervention)
- Change from baseline in diet composition at 2 months(At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention)
- Feasibility of the assigned TRE intervention(at the end of the 8 week intervention)