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Completed

NCT Number: NCT04105621

Westlake Personalized Nutrition and Health Cohort for Drug Addicts

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.

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Key information

Conditions

Drug Addiction Chemically-Induced Disorders Drug Abuse Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Substance-Related Disorders Undernutrition

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Drug Rehabilitation Administration

Hangzhou, Zhejiang, 310008, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Continuous blood glucose profile over 2 weeks

    Time frame: Two weeks after enrollment

    Glucose levels were measured using continuous glucose monitoring over 2 week

  2. The dynamic change of gut microbiota within one year

    Time frame: 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 outcomes

  1. Drug craving intensity

    Time frame: 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.

  2. The change of BMI

    Time frame: Baseline; 6 months after enrollment; 12 months after enrollment

    BMI in kg/m^2

  3. Nutritional status

    Time frame: Baseline; 6 months after enrollment; 12 months after enrollment

    Nutritional status was measured by mini nutritional assessment (MNA) screening test.

  4. The degree of depression

    Time frame: 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.

  5. The degree of anxiety

    Time frame: 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.

  6. Body composition

    Time frame: Baseline; 6 months after enrollment; 12 months after enrollment

    Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Zhejiang Drug Rehabilitation Administration

Registry information

Acronym: WePN-DA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2019
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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