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

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).

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia; Bipolar Disorder
• Intervention / Treatment: Other: Placebo; Dietary supplement: Green Tea

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Non-active "sugar pill"	Other: Placebo; Non-active "sugar pill".
Active Comparator: 2; Green Tea Capsules	Dietary supplement: Green Tea; Green tea capsules taken twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attenuation of weight and fat gain in patients initiating therapy with Zyprexa®	Weeks 1, 6 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®.	Weeks 1, 6 and 12

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Jennifer L Donovan, PhD, Medical University of South Carolina; Study Chair: Thomas W Uhde, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: ALL; Zyprexa®; Green Tea
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Body Weight; Schizophrenia Spectrum and Other Psychotic Disorders; Body Weight Changes; Lipid Metabolism Disorders; Bipolar and Related Disorders; Schizophrenia; Dyslipidemias; Bipolar Disorder; Weight Gain
• Other Study ID Numbers: Green Tea and Olanzapine