Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine

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.

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