Effects of Time-restricted Eating Combined With Aerobic Exercise Training on Body Composition and Cardiometabolic Parameters in Women With Overweight and Obesity: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Insulin sensitivity (indices)
研究概览
简要总结
Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.
Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.
The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 25 and 34.9 kg/m²;
- •Age between 20 and 40 years;
- •Not engaged in any structured exercise program;
- •Weight stable for ~3 months before the beginning of the study;
- •Able to give written informed consent.
排除标准
- •Current smoker;
- •Habitual drinkers (>1 serving/day) of alcoholic beverages;
- •Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
- •Current treatment with medication or supplements which significantly affect the main studied variables;
- •Bariatric surgery;
- •Night-shift workers;
- •Strict vegetarian/vegan;
- •Pregnancy, planned pregnancy (within the study period), lactating;
- •Postmenopausal women;
- •Self-reported menstrual cycle irregularities;
- •Habitual fasting window >16 hours;
- •Concomitant participation in other studies.
研究组 & 干预措施
Time-Restricted Eating and Aerobic Exercise Performed in Fasted State
Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them.
Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat.
Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner).
Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the morning shift with participants in a fasted state.
干预措施: Dietary and Exercise Approaches (Behavioral)
Time-Restricted Eating and Aerobic Exercise Performed in Fed State
Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them.
Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat.
Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner).
Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the afternoon shift with participants in a fed state.
干预措施: Dietary and Exercise Approaches (Behavioral)
Time-Restricted Eating
Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them.
Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat.
Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner).
Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Participants in this arm will not perform aerobic exercise training.
干预措施: Dietary Approach (Behavioral)
结局指标
主要结局
Insulin sensitivity (indices)
时间窗: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to the Sensitivity Matsuda index
次要结局
- Fasting ketones (β-hydroxybutyrate) levels (mmol/L)(Change from baseline. Measured at baseline and after 8 weeks.)
- Glucose tolerance(Change from baseline. Measured at baseline and after 8 weeks.)
- Fat Mass (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fat Free Mass (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
- Bone Mineral Content (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
- Absolute Peak oxygen consumption(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
- Fasting Adiponectin Levels(Change from baseline. Measured at baseline and after 8 weeks.)
- LDL-cholesterol levels(Change from baseline. Measured at baseline and after 8 weeks.)
- Non-HDL-cholesterol levels(Change from baseline. Measured at baseline and after 8 weeks.)
- Insulin resistance (indices)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fasting insulin levels (µIU/mL)(Change from baseline. Measured at baseline and after 8 weeks.)
- β cell function (indices)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fat Percentage (%)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fasting glucose levels (mg/dL)(Change from baseline. Measured at baseline and after 8 weeks.)
- Fasting lipid profile levels(Change from baseline. Measured at baseline and after 8 weeks.)
- Body Mass Index (kg/m^2)(Change from baseline. Measured at baseline and after 8 weeks.)
- Resting metabolic rate (Kcal/day)(Change from baseline. Measured at baseline and after 8 weeks.)
- Substrate Oxidation (respiratory exchange ratio)(Change from baseline. Measured at baseline and after 8 weeks.)
- Relative Peak oxygen consumption(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
- Body Weight (kg)(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
- Inflammatory Markers Levels(Change from baseline. Measured at baseline and after 8 weeks.)
- Fasting Leptin Levels(Change from baseline. Measured at baseline and after 8 weeks.)
研究者
Alvaro Reischak-Oliveira
Professor
Federal University of Rio Grande do Sul