The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health; Randomized Controlled Trial (TERA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Primary aim muscle mass
研究概览
简要总结
The aim of the study is to determine the effect of resistance training (RT) combined with time-restricted eating (TRE) or normal diet (ND) on muscle mass, and strength. Additionally, the study will compare between TRE and ND and its effects on cardiometabolic health, mitochondria function and body composition among people with metabolic syndrome.
In this randomized controlled trial, 50 males with metabolic syndrome (elevated waist circumference, blood pressure, triglycerides, fasting glucose and low high-density lipoprotein cholesterol) between the age of 40-60y and with BMI between 25-33 kg/m2 will be randomized to either TRE+RT (n=25) or ND+RT (n=25). All participants will perform supervised and monitored RT three time per week for the 10 weeks of intervention Study measurements; Changes in body composition, muscle mass and adipose tissue distribution will be measured by 3-Tesla magnetic resonance imaging (MRI), dual energy x-ray absorptiometry (DXA), air displacement plethysmography (BODPOD) and Bioelectrical Impedance analysis (BIA). Muscular Strength will be assessed. Blood samples, including lipid and glycemic profile. muscle biopsy taken from the vastus lateralis muscle.
详细描述
Primary aim. Determine the effect of TRE or ND, combined with RT training, on muscle mass and strength as adaptive response to 10 weeks of intervention among people with metabolic syndrome.
Secondary aims. Determine the effect of TRE combined with RT on cardiometabolic health lipid profile and HbA1C (C), Mitochondria function and oxygen consumption (D) and Body composition assessment (E).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject with metabolic syndrome
- •BMI between 25-33 kg/m²
- •Age 40-60
- •Without cardiac and pulmonary disease
- •Did not engage exercise training in the last year.
- •Willing and able to read, understand and sign an informed consent
排除标准
- •Participants that have cardiopulmonary disease
- •Inability to attend scheduled clinic visits and/or comply with the study protocol
- •Active smokers
- •Previous regular exercise training in the previous yea
- •Major orthopedic injury at the past 3 months
- •Inability to perform an MRI (due to claustrophobia, or metal in their body)
- •Subjects that uses drugs that affect muscle metabolism
研究组 & 干预措施
Time-restricted eating
Participants in the TRE group will be instructed to consume all meals between 12pm to 8pm (8 h eating window with 16 h of fasting)
干预措施: Time-restricted eating (Behavioral)
Normal Diet (ND)
The ND group will consume all meals between 6 am - 10 pm (16 h eating window with 8 h of fasting, ad-libitum)
干预措施: Normal Diet (Other)
结局指标
主要结局
Primary aim muscle mass
时间窗: 10 weeks
Muscle mass volume using MRI (cm3)
Primary aim Maximum strength
时间窗: 10 weeks
Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)
Primary aim free fat mass
时间窗: 10 weeks
Free fat mass will be mesured in in kg using DXA , BOD POD and BIA
次要结局
- Secondary aims Cardiometabolic profile(10 weeks)
- Secondary aims body composition assessment(10 weeks)
研究者
Gepner Yftach
Principal Investigator
Tel Aviv University