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Green Tea Extract for Obesity of Psychiatric Patients (GEOP)

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ClinicalTrials.gov Identifier: NCT03548103
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Lin, Shih-Ku, Taipei City Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Dietary Supplement: Green tea extract Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind placebo-controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Placebo
Primary Purpose: Treatment
Official Title: Green Tea Extract for Obesity of Psychiatric Patients: a Double Blind Placebo-controlled Trial
Actual Study Start Date : May 20, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Green Tea Extract
Green Tea Extract 500 mg per capsule
Dietary Supplement: Green tea extract
Green tea extract 500 mg tid for 16 weeks

Placebo Comparator: Placebo
Identical Placebo capsule
Dietary Supplement: Placebo
Placebo tid for 16 weeks




Primary Outcome Measures :
  1. Body weight change in patients treated with psychotropic medications [ Time Frame: 16 weeks ]
    Body weight decreas in kilogram after treatment


Secondary Outcome Measures :
  1. Change of metabolic biochemistry profile composite [ Time Frame: 16 weeks ]
    The change of Blood sugar in mg/dL, Triglyceride in mg/dL, Cholesterol in mg/dL, HDL-cholesterol in mg/dL, LDL-cholesterol in mg/dL, Hormone peptides Insulin in ng/mL, Leptin in ng/mL, Adiponectin in ng/mL and Ghrelin in ng/mL



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Age between 20 to 65 years.
    2. Currently taking antipsychotics or mood stabilizers.
    3. BMI should be ≥ 27 kg/m2.
    4. Good adherence to medications as recorded by chart.
    5. Competent to understand the informed consent and have motivation to decrease their body weight.

Exclusion Criteria:

  1. Unstable psychiatric symptoms or physical condition that may interfere the adherence of medication.
  2. 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.
  3. Pregnant or lactating women.
  4. Childbirth within 6 months.
  5. Management for weight control within 3 months.
  6. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

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): NCT03548103


Contacts
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Contact: Shih-Ku Lin, MD 886227263141 ext 1303 sklin@tpech.gov.tw

Locations
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Taiwan
Taipei City Hospital and Psychiatric Center Recruiting
Taipei, Taiwan, 110
Contact: Shih-Ku Lin, MD    886979307713    sklin@tpech.gov.tw   
Contact: Yen-Lung Chiu, Master    88627263141 ext 1224    yann.tpech@gmail.com   
Sponsors and Collaborators
Taipei City Hospital

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Responsible Party: Lin, Shih-Ku, Chair, Department of Psychiatry, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT03548103     History of Changes
Other Study ID Numbers: 10701-62-016
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases