跳至主要内容
临床试验/NCT04275440
NCT04275440已完成不适用

Effects of Caloric Restriction and Exercise on Body Weight, Cardiometabolic Risk Markers, Immune Function, and Intestinal Flora in College Students: a Randomized Controlled Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2019年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
195
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 caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms.

详细描述

In recent decades, carbohydrate-centered food pattern has brought worrying negative effects on human health, including increasing incidence of overweight, obesity, and cardiovascular diseases. Animal experiments based on rhesus monkey showed that caloric restriction could prolong their healthy life years, while reports from population-based studies are quite inconclusive. There are some studies reporting that caloric restriction did reduce the risk of cardiovascular disease in those with obesity, while some other cohort studies found that not eating breakfast might increase the risk of coronary heart disease, diabetes and other related diseases. In addition, a number of studies claimed that continuous caloric restriction is associated with the depletion of peripheral immune cells, immune suppression and reduced bone mineral density. In spite of those inconclusive results, on the whole, fasting and caloric restriction in some way do improve the conditions of metabolism, overweight and obesity. Previous studies mostly focused on middle-aged and elderly people, while recent studies in mice show that energy limitation in elderly people could not stop the aging process genetically or metabolically. Therefore, this study aims to estimate the effects of caloric restriction and exercise on body weight, cardiovascular metabolic markers, immune function, and intestinal flora among college students, as well as the underlying mechanisms. A pilot study containing around 40 participants will be conducted firstly to assess the feasibility of this intervention plan.

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
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • First and second year undergraduate students in Sun Yat-sen University.
  • BMI≥22 kg/m
  • Having the time and volunteering to receive the interventions.

排除标准

  • Currently engaged in other weight-lossing studies.
  • With secondary obesity induced by medicine or other diseases.
  • With high blood pressure, diabetes or other cadiovascular 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 (8 weeks), 8 weeks after completion of the intervention

Body weight change of participants

次要结局

  • Serum lipid levels(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Circulating metabolome(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Body composition(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Systolic and diastolic blood pressure(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Fasting plasma glucose(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Intestinal flora(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Immune inflammation indicators(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)
  • Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)(Baseline (1-2 days before the intervention), right after intervention (8 weeks), 8 weeks after completion of the intervention)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanna Zhu

Associate Professor

Sun Yat-sen University

研究点 (1)

Loading locations...

相似试验