Westlake Personalized Nutrition and Health Cohort for Drug Addicts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Continuous blood glucose profile over 2 weeks
研究概览
简要总结
This is a prospective cohort study of drug addicts confined in Zhejiang rehabilitation centers. The primary aim of this study is to investigate the association between diet and health status among drug addicts. The second aim is to characterize the continuous blood glucose response to dietary intakes over 2 weeks. The third aim is to describe the dynamic changes of gut microbiota at three time points in drug addicts during compulsory detoxification and to evaluate the association between gut microbiota, diet and addiction severity.
详细描述
Over recent decades, there is a growing trend of drug addiction in China that poses great public health challenges. Drug abuse can lead to many health related problems such as malnutrition and mental disorders along with reduced quality of life. Dietary intervention plays a pivotal role in disease prevention and drug rehabilitation for drug addicts, but the associations between dietary intake and health related outcomes among drug addicts remain unclear.
In addition, the relationship between the human gut microbiota and its response to addictive drugs as a newly arisen subject is given wide attention in recent years. However, the underlying mechanism requires further investigation. The dynamic changes of gut microbiota among drug addicts during compulsory drug rehabilitation period are in vague.
Under the same diet exposure, different drug addicts may have different blood glucose responses as well as gut microbiota profiles. Therefore, in order to examine the association between diet, gut microbiota and drug addiction, our study design will include three components: (1) the measurement of dietary intake using FFQ while the menu offered by drug rehabilitation center and food diary; (2) the measurements of blood glucose over 2 weeks using continuous glucose monitors; and (3) the measurements of gut microbiota at three time points using 16s rRNA sequencing techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Drug addicts aged between 18 yrs and 65yrs.
- •Drug addicts lived in Zhejiang drug rehabilitation centers.
- •Drug addicts who have stayed in drug rehabilitation center for no more than 6 months.
排除标准
- •Drug addicts diagnosed with cancer or other serious physical and mental disorders.
结局指标
主要结局
Continuous blood glucose profile over 2 weeks
时间窗: Two weeks after enrollment
Glucose levels were measured using continuous glucose monitoring over 2 week
The dynamic change of gut microbiota within one year
时间窗: One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment.
Fecal microbiota was analyzed using16S rRNA gene sequencing technique
次要结局
- Nutritional status(Baseline; 6 months after enrollment; 12 months after enrollment)
- Drug craving intensity(Baseline; 6 months after enrollment; 12 months after enrollment)
- The change of BMI(Baseline; 6 months after enrollment; 12 months after enrollment)
- The degree of depression(Baseline; 6 months after enrollment; 12 months after enrollment)
- The degree of anxiety(Baseline; 6 months after enrollment; 12 months after enrollment)
- Body composition(Baseline; 6 months after enrollment; 12 months after enrollment)