Clinical trial NCT00934908: Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
Official title: Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar Disorder
Schizophrenia
Keywords: Zyprexa®
Green Tea
ALL
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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 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

Primary outcomes:
measure: Attenuation of weight and fat gain in patients initiating therapy with Zyprexa®
timeFrame: Weeks 1, 6 and 12
Secondary outcomes:
measure: Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®.
timeFrame: Weeks 1, 6 and 12
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jennifer L Donovan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Thomas W Uhde, MD
role: STUDY_CHAIR
References: