Westlake Personalized Nutrition and Health Cohort for Drug Addicts

Drug Abuse Clinical Trial

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Official title:

Westlake Personalized Nutrition and Health Cohort for Drug Addicts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105621
• Other study ID #: 20190812ZJS0009
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: October 2020
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Abuse
• Drug Addiction
• Malnutrition
• Substance-Related Disorders
• Undernutrition

Locations

Country	Name	City	State
China	Zhejiang Drug Rehabilitation Administration	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Zhejiang Drug Rehabilitation Administration

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous blood glucose profile over 2 weeks	Glucose levels were measured using continuous glucose monitoring over 2 week	Two weeks after enrollment
Primary	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	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
Secondary	The change of BMI	BMI in kg/m^2	Baseline; 6 months after enrollment; 12 months after enrollment
Secondary	Nutritional status	Nutritional status was measured by mini nutritional assessment (MNA) screening test.	Baseline; 6 months after enrollment; 12 months after enrollment
Secondary	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
Secondary	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
Secondary	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