Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Metabolic Syndrome Z score
研究概览
简要总结
Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis.
This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS.
The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation):
- •Waist circumference ≥ 92 cm (Men) or ≥ 80 cm (Women).
- •Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides).
- •Reduced HDL-C < 40 mg/dL (Men), < 50 mg/dL (Women) (or on drug treatment for reduced HDL-C).
- •Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with an antihypertensive drug with a history of hypertension).
- •Elevated fasting glucose ≥ 100 mg/dL (or drug treatment of elevated blood glucose).
- •Age ≥18 to ≤65 years
- •Previously inactive (<150 min·wk-1 of the moderate-intensity activity assessed by 7-d IPAQ
排除标准
- •Pregnancy, and lactation within 24 weeks of study commencement
- •Untreated cardiovascular or renal disease
- •Type 1 diabetes
- •Any condition associated with exercise intolerance.
- •Habitual eating window < 12 hours
- •Performing high-intensity training more than once a week
- •Body mass variations > 4 kg three months prior to study commencement
- •Shift work that includes night shifts
研究组 & 干预措施
Control
Information about the recommended level of physical activity for health benefits and a healthy diet will be given.
High-Intensity Interval Training
High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.
干预措施: High-Intensity Interval Training (Behavioral)
Time-Restricted Eating
Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours
干预措施: Experimental: Time-Restricted Eating (Behavioral)
High Intensity Interval Training & Time-Restricted Eating
High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.
Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours
干预措施: High-Intensity Interval Training (Behavioral)
High Intensity Interval Training & Time-Restricted Eating
High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.
Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours
干预措施: Experimental: Time-Restricted Eating (Behavioral)
结局指标
主要结局
Metabolic Syndrome Z score
时间窗: Baseline and after 16 weeks of intervention
MetS z score will be used to assess the continuous rather than dichotomous (have/not haveMetS) evolution of each MetS component into a compound score. We will calculate the Z score as the difference between the subjects and the threshold value divided by the group standard deviations for each MetS criterion.
次要结局
- Glycemia(Baseline and after 16 weeks of intervention)
- Insulin sensitivity(Baseline and after 16 weeks of intervention)
- Cardiorespiratory fitness(Baseline and after 16 weeks of intervention)
- Central obesity(Baseline and after 16 weeks of intervention)
- Body composition(Baseline and after 16 weeks of intervention)
- Insulin(Baseline and after 16 weeks of intervention)
- Blood lipids profile(Baseline and after 16 weeks of intervention)
- Blood pressure(Baseline and after 16 weeks of intervention)
研究者
Felix Morales Palomo
PhD
University of Castilla-La Mancha