Green Tea Extract for Obesity of Psychiatric Patients

NCT03548103 | Completed

• 1 other identifier: 10701-62-016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Body weight change in patients treated with psychotropic medications

  Body weight decreas in kilogram after treatment

  16 weeks

Secondary Outcomes (1)

• Change of metabolic biochemistry profile composite

  16 weeks

Study Arms (2)

Green Tea Extract

EXPERIMENTAL

Green Tea Extract 500 mg per capsule

Dietary Supplement: Green tea extract

Placebo

PLACEBO COMPARATOR

Identical Placebo capsule

Dietary Supplement: Placebo

Interventions

Green tea extract DIETARY_SUPPLEMENT

Green tea extract 500 mg tid for 16 weeks

Green Tea Extract

Placebo DIETARY_SUPPLEMENT

Placebo tid for 16 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with schizophrenia or mood disorders, followed at Taipei City Psychiatric Center will be the targeted study population. The subjects should fulfill the following criteria:
• Age between 20 to 65 years.
• Currently taking antipsychotics or mood stabilizers.
• BMI should be ≥ 27 kg/m2.
• Good adherence to medications as recorded by chart.
• Competent to understand the informed consent and have motivation to decrease their body weight.

You may not qualify if:

• Unstable psychiatric symptoms or physical condition that may interfere the adherence of medication.
• Medical conditions such as endocrine disease, heart disease, allergy or immunology disease, or impaired liver function (high aminotransferases, alanine, aspartate \>80 IU/L or serum creatinine \>2.5 mg/dl.
• Pregnant or lactating women.
• Childbirth within 6 months.
• Management for weight control within 3 months.
• Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital and Psychiatric Center

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Tea

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Psychiatry

Model Details: double blind placebo-controlled trial

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: June 7, 2018
• Study Start: May 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)