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Westlake Personalized Nutrition and Health Cohort for Drug Addicts

Westlake Personalized Nutrition and Health Cohort for Drug Addicts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04105621
Acronym
WePN-DA
Enrollment
228
Registered
2019-09-26
Start date
2019-10-28
Completion date
2021-01-20
Last updated
2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Abuse, Drug Addiction, Undernutrition

Keywords

Personalized nutrition, Drug addicts, Gut microbiota

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.

Interventions

None listed

Sponsors

Zhejiang Drug Rehabilitation Administration
CollaboratorUNKNOWN
Westlake University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Continuous blood glucose profile over 2 weeksTwo weeks after enrollmentGlucose levels were measured using continuous glucose monitoring over 2 week
The dynamic change of gut microbiota within one yearOne 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

MeasureTime frameDescription
Nutritional statusBaseline; 6 months after enrollment; 12 months after enrollmentNutritional status was measured by mini nutritional assessment (MNA) screening test.
The degree of depressionBaseline; 6 months after enrollment; 12 months after enrollmentThis 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.
Drug craving intensityBaseline; 6 months after enrollment; 12 months after enrollmentThis 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.
Body compositionBaseline; 6 months after enrollment; 12 months after enrollmentBody composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.
The degree of anxietyBaseline; 6 months after enrollment; 12 months after enrollmentThis 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.
The change of BMIBaseline; 6 months after enrollment; 12 months after enrollmentBMI in kg/m\^2

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026