Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
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|ClinicalTrials.gov Identifier: NCT00934908|
Recruitment Status : Withdrawn
First Posted : July 8, 2009
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Schizophrenia||Dietary Supplement: Green Tea Other: Placebo||Not Applicable|
Atypical antipsychotic (AA) medications are associated with obesity, diabetes mellitus, dyslipidemia, and cardiovascular disease.1 The prevalence of obesity in the AA medicated population ranges from 40-60%, compared to 30% of the general population. Treatments that are aimed at either reducing the burden of obesity in psychotic illness or preventing the weight gain and other metabolic changes associated with AA are needed. One potential therapy that has received inadequate clinical evaluation is Green tea (Camillia sinensis; GT). GT contains flavonoids including epigallocatechin gallate (EGCG), as well as caffeine, that have been documented to promote weight and fat loss in normal to overweight healthy subjects. Recently green tea was shown to significantly decrease plasma LDL and triglyceride concentrations and increase HDL concentrations in obese women. GT has never been evaluated for its potential to prevent weight gain or changes in plasma lipid concentrations in patients initiating therapy with AA. However, case reports of individuals indicate that treatment with a green tea extract may have efficacy in preventing weight gain in 4 patients that initiated treatment with quetiapine.
We hypothesize that intake of GT in the form of a dietary supplement will result in significantly less weight gain than supplementation with placebo in patients initiating therapy with Zyprexa®. We propose to conduct an 12-week double-blind, placebo-controlled pilot study of 48 out-patient volunteers to determine if twice daily supplementation with GT 1) attenuates weight and fat gain in patients initiating therapy with Zyprexa® and 2) attenuates changes in cardiovascular risk factors including plasma lipoprotein and triglyceride concentrations. The experiments will be performed on patients who initiate therapy with Zyprexa® with a BMI < 40kg/m2 that do not have dyslipidemia requiring pharmacologic intervention.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine|
|Actual Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Placebo Comparator: 1
Non-active "sugar pill"
Non-active "sugar pill".
Active Comparator: 2
Green Tea Capsules
Dietary Supplement: Green Tea
Green tea capsules taken twice a day.
- Attenuation of weight and fat gain in patients initiating therapy with Zyprexa® [ Time Frame: Weeks 1, 6 and 12 ]
- Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®. [ Time Frame: Weeks 1, 6 and 12 ]
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): NCT00934908
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Jennifer L Donovan, PhD||Medical University of South Carolina|
|Study Chair:||Thomas W Uhde, MD||Medical University of South Carolina|