Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
Information source: Medical University of South Carolina
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Schizophrenia
Intervention: Green Tea (Dietary Supplement); Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Medical University of South Carolina Official(s) and/or principal investigator(s):
Jennifer L Donovan, PhD, Principal Investigator, Affiliation: MUSC
Summary
The purpose of this study is to determine if taking green tea capsules can help prevent
weight gain in patients that start therapy with Zyprexa® (olanzapine).
Clinical Details
Official title: Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Attenuation of weight and fat gain in patients initiating therapy with Zyprexa®
Secondary outcome: Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Concurrently taking Zyprexa® for a psychiatric indication such as bipolar disorder or
schizophrenia
- Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit
- No weight loss program participation within past 3 months
Exclusion Criteria:
- Treatment with an atypical Anti-psychotic treatment other than olanzapine with the
past 6 months
- BMI > 40 kg/m2
- Use of any dietary supplements related to weight gain or weight loss within past 1
month
- Use of any medication related to weight or plasma lipid concentration (other than
hormonal contraceptives). This includes, but not limited to: antihypertensives,
benzodiazepines statins, and psychostimulants.
- Uncontrolled hypertension (SBP >140 or DBP > 90 mmHg)
- Use of a hypertensive medication
- Known active alcohol or substance abuse or consumption of > three alcoholic
beverages/day.
- Active cardiovascular disease
Locations and Contacts
Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Shelley Sherk, CCRC, Email: sherk@musc.edu
Jennifer L Donovan, PhD, Principal Investigator
Additional Information
Starting date: March 2009
Ending date: March 2011
Last updated: July 7, 2009
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