Clinical trial NCT04105621: Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Official title: Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Addiction
Undernutrition
Drug Abuse
Keywords: Personalized nutrition
Drug addicts
Gut microbiota
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: Zhejiang Drug Rehabilitation Administration
First posted: 2019-09-26
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Drug addicts diagnosed with cancer or other serious physical and mental disorders.

Primary outcomes:
measure: Continuous blood glucose profile over 2 weeks
timeFrame: Two weeks after enrollment
measure: The dynamic change of gut microbiota within one year
timeFrame: One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment.
Secondary outcomes:
measure: Drug craving intensity
timeFrame: Baseline; 6 months after enrollment; 12 months after enrollment
measure: The change of BMI
timeFrame: Baseline; 6 months after enrollment; 12 months after enrollment
measure: Nutritional status
timeFrame: Baseline; 6 months after enrollment; 12 months after enrollment
measure: The degree of depression
timeFrame: Baseline; 6 months after enrollment; 12 months after enrollment
measure: The degree of anxiety
timeFrame: Baseline; 6 months after enrollment; 12 months after enrollment
measure: Body composition
timeFrame: Baseline; 6 months after enrollment; 12 months after enrollment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Drug Rehabilitation Administration
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: