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Trial record 1 of 1 for:    NCT04105621
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Westlake Personalized Nutrition and Health Cohort for Drug Addicts (WePN-DA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105621
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Zhejiang Drug Rehabilitation Administration
Information provided by (Responsible Party):
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.

Condition or disease
Drug Addiction Undernutrition Drug Abuse

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.

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Study Type : Observational
Actual Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Actual Study Start Date : October 28, 2019
Actual Primary Completion Date : January 20, 2021
Actual Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Fasting venous blood, urine, saliva and stool.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105621


Locations
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China, Zhejiang
Zhejiang Drug Rehabilitation Administration
Hangzhou, Zhejiang, China, 310008
Sponsors and Collaborators
Westlake University
Zhejiang Drug Rehabilitation Administration
Investigators
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Principal Investigator: Ju-Sheng Zheng, PhD Westlake University
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Responsible Party: Westlake University
ClinicalTrials.gov Identifier: NCT04105621    
Other Study ID Numbers: 20190812ZJS0009
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Westlake University:
Personalized nutrition
Drug addicts
Gut microbiota
Additional relevant MeSH terms:
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Malnutrition
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nutrition Disorders