Westlake Personalized Nutrition and Health Cohort for Drug Addicts (WePN-DA)

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.

Study Overview

• Status: Completed
• Conditions: Drug Abuse; Drug Addiction; Undernutrition

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 Type: Observational
• Enrollment (Actual): 228

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310008
      • Zhejiang Drug Rehabilitation Administration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Drug addicts; This group included drug addicts lived in drug rehablitation center.
Healthy population; We recruited the healthy participants from the Westlake N-of-1 Trials for Macronutrient Intake (NCT04125602) as healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous blood glucose profile over 2 weeks	Glucose levels were measured using continuous glucose monitoring over 2 week	Two weeks after enrollment
The dynamic change of gut microbiota within one year	Fecal microbiota was analyzed using16S rRNA gene sequencing technique	One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug craving intensity	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.	Baseline; 6 months after enrollment; 12 months after enrollment
The change of BMI	BMI in kg/m^2	Baseline; 6 months after enrollment; 12 months after enrollment
Nutritional status	Nutritional status was measured by mini nutritional assessment (MNA) screening test.	Baseline; 6 months after enrollment; 12 months after enrollment
The degree of depression	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.	Baseline; 6 months after enrollment; 12 months after enrollment
The degree of anxiety	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.	Baseline; 6 months after enrollment; 12 months after enrollment
Body composition	Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.	Baseline; 6 months after enrollment; 12 months after enrollment

Collaborators and Investigators

• Sponsor: Westlake University
• Collaborators: Zhejiang Drug Rehabilitation Administration

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Gut microbiota; Personalized nutrition; Drug addicts
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Nutrition Disorders; Substance-Related Disorders; Malnutrition
• Other Study ID Numbers: 20190812ZJS0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No