Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
详细描述
In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders. The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions. A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function. While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks. Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function. Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear. More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function. Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First and second year undergraduate students in Sun Yat-sen University.
- •BMI≥22 kg/m^
- •Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg).
- •Having the time and volunteering to receive the interventions.
排除标准
- •Currently engaged in other weight-loss studies.
- •With high blood pressure, diabetes or other cardiovascular diseases.
- •With secondary obesity induced by medicine or other diseases.
- •Contraindication to exercise.
结局指标
主要结局
Body weight
时间窗: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
Body weight change of participants
次要结局
- Intestinal flora(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Body fat percentage(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Fat mass(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Systolic and diastolic blood pressure(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Serum lipid levels(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Fasting plasma glucose(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Change in appetite sensations(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Intercellular adhesion molecule-1 (ICAM-1)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Tumor necrosis factor alpha (TNF-alpha)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Chemokine CCL2(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Vascular cell adhesion molecule (VCAM-1)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Interleukin-6 (IL-6)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Interleukin-8 (IL-8)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Leptin(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Tau protein(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Brain-derived neurotrophic factor (BDNF)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Vascular endothelial growth factor (VEGF)(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Fasting plasma insulin(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
- Circulating metabolome(Baseline (1-2 days before the intervention), right after intervention (12 weeks))
研究者
Yanna Zhu
Associate Professor
Sun Yat-sen University