Westlake Personalized Nutrition and Health Cohort for Drug Addicts

NCT ID: NCT04105621

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2021-01-20

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.

Conditions

Drug Addiction; Undernutrition; Drug Abuse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Drug addicts

This group included drug addicts lived in drug rehablitation center.

No interventions assigned to this group

Healthy population

We recruited the healthy participants from the Westlake N-of-1 Trials for Macronutrient Intake (NCT04125602) as healthy control

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Drug Rehabilitation Administration

UNKNOWN

Sponsor Role: collaborator

Westlake University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ju-Sheng Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Westlake University

Locations

Zhejiang Drug Rehabilitation Administration

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20190812ZJS0009

Identifier Type: -

Identifier Source: org_study_id