Westlake Personalized Nutrition and Health Cohort for Drug Addicts

Completed

• Conditions: Drug Abuse; Drug Addiction; Undernutrition

• Registration Number: NCT04105621
• Lead Sponsor: Westlake University

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.

Study Timeline

• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2019-10-28
• Status Verified: 2020-10
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continuous blood glucose profile over 2 weeks	Two weeks after enrollment	Glucose levels were measured using continuous glucose monitoring over 2 week
The dynamic change of gut microbiota within one year	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

Secondary Outcome Measures

Name	Time	Method
Nutritional status	Baseline; 6 months after enrollment; 12 months after enrollment	Nutritional status was measured by mini nutritional assessment (MNA) screening test.
Drug craving intensity	Baseline; 6 months after enrollment; 12 months after enrollment	This was evaluated by Obsessive Compulsive Drug Use Scale (OCDUS). This scale had 13 items, each with a 5-point Likert-response (1, 2, 3, 4 and 5). Items 6 and 13 were reverse-scored. The total score ranges from 13 to 65 and a higher value represent a higher intensity of drug craving.
The change of BMI	Baseline; 6 months after enrollment; 12 months after enrollment	BMI in kg/m\^2
The degree of depression	Baseline; 6 months after enrollment; 12 months after enrollment	This was evaluated by Beck Depression Inventory-II (BDI-II). Scores in every item of the BDI-II were between 0 and 3. The total score ranges from 0 to 63.
The degree of anxiety	Baseline; 6 months after enrollment; 12 months after enrollment	This was evaluated by Hamilton Anxiety Scale (HAMA). Scores in every item of the HAMA were between 0 and 4. The total score ranges from 0 to 56.
Body composition	Baseline; 6 months after enrollment; 12 months after enrollment	Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.

Trial Locations

Locations (1)

Zhejiang Drug Rehabilitation Administration; 🇨🇳 Hangzhou, Zhejiang, China