跳至主要内容
临床试验/NCT02539836
NCT02539836已完成不适用

Study on Dietary Nutrition Intervention Techniques for Children Obesity

Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
BMI change

研究概览

简要总结

With the rapid development of society and economy, children's simple obesity is the rising in the world and has become a chronic disease which is one of the biggest public health challenges in the world. It is a serious threat to the health of children and their adulthood. The overweight and obesity is induced by the genetic and environmental factors. The environmental factors are very important, while the dietary factors are the driving factors of many chronic diseases including obesity. This study focus on the dietary intervention of childhood obesity to build healthy intestinal flora. The interventing food was based on a natural health food - fruit and vegetable fermentation liquid, and combined with other probiotic dietary factors, dietary fiber and oligosaccharides. The implementation of the study will help to reveal the fuction mechanism of intestinal bacteria in the obese children and normal children, and to construct healthy micro environment of intestinal flor. According to the positive effect factors, the study will propose a healthy diet and nutrition intervention model for obese children, which is significant to social health especially to children's health.

To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference. A secondary goal was to assess the prevalence of nonalcoholic fatty liver disease in overweight and obese Chinese children and adolescents.

详细描述

Before academic examination, letter to parents, informed consent and volunteer questionnaire are released to school children and their guardians. We tell the volunteers and their guardians what about this study and invite them to participate this study. Only the volunteers and guardians signature on the letter to parents and informed consent are able to the research objects.

Experimental procedures:

Two times of medical exams, blood and stool sample collection is required for the whole experiment research. The first time exams and sample collection is carried on during academic examination; the second time is carried on after the intervention.

Recruit of research objects:

According to academic examination and volunteer questionnaires, about 300 healthy children without in taking antibiotics before 3 months are recruited and their BMI should be in the obese range. Then their waist circumference and the ratio of body fat are measured. If the ratio of waist size to weight of them is >0.46 and they have higher percentage of body fat (>20% for boys and under 12 years old girls, >25% for 12 years old girls), the data are collected and input to the database. About 40 healthy children between 15-18 years old are recruited to participate the next intervention research.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • People whose BMI>27 and Age between 15-18;the value of waistline/weight >0.46; the value of body composition >20%.

排除标准

  • People treated by antibiotic drugs in 3 months;People with gastrointestinal diseases;People with Type I diabetes, any eating disorders such as bulimia or anorexia nervosa; Prader-Willi patients and obesity is part of clinical syndrome with other disorders.

结局指标

主要结局

BMI change

时间窗: 2 months

次要结局

  • Gut microbiome profile change(2 months)
  • Weight loss(2 months)
  • Serum biomarkers change(2 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yonglong Pan

Research associate

Chinese Academy of Sciences

研究点 (1)

Loading locations...

相似试验

Study on Dietary Nutrition Intervention Techniques... | 临床试验