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Green Tea Extract for Obesity of Psychiatric Patients

NCT03548103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-04-12

No results posted yet for this study

Summary

Obesity or metabolic syndrome is becoming a global epidemic and common health problem, leading to the increase of associated comorbidities such as type 2 diabetes, cardiovascular disease, and certain cancers. This phenomenon is also a serious problem among psychiatric patients due to the increase use of second generation antipsychotics and mood stabilizers such as lithium or valproic acid. These metabolic abnormalities can be regarded as medical comorbidities, and have an impact not only on physical health and increased hospital length of stay, but also on a lower functional outcome, low self-esteem and poorer quality of life and non-compliance to antipsychotics. Green tea is one of the most popular beverages in the world and is believed to have beneficial effects in prevention and treatment of many diseases, such as cancer-prevention, adjunct to chemotherapy for malignancy, to reduce mental and physical stress and improve memory function, to increase bone mineral density, and to decrease body weight. Since weight gain is a common and undesirable side effect with psychiatric medications, the management of it becomes an important issue in clinical practice. In this clinical trial, we will use decaffeinated green tea extract to treat overweight patients with schizophrenia or bipolar disorder in a double-blind, placebo-controlled study design.

Conditions

Interventions

DIETARY_SUPPLEMENT

Green tea extract

Green tea extract 500 mg tid for 16 weeks

DIETARY_SUPPLEMENT

Placebo

Placebo tid for 16 weeks

Sponsors & Collaborators

  • Taipei City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-20
Primary Completion
2019-12-31
Completion
2020-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548103 on ClinicalTrials.gov