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

NCT00934908 | Withdrawn

• 1 other identifier: Green Tea and Olanzapine
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Bipolar Disorder; Schizophrenia

Keywords

Zyprexa®; Green Tea; ALL

Outcome Measures

Primary Outcomes (1)

• Attenuation of weight and fat gain in patients initiating therapy with Zyprexa®

  Weeks 1, 6 and 12

Secondary Outcomes (1)

• Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®.

  Weeks 1, 6 and 12

Study Arms (2)

1

PLACEBO COMPARATOR

Non-active "sugar pill"

Other: Placebo

2

ACTIVE COMPARATOR

Green Tea Capsules

Dietary Supplement: Green Tea

Interventions

Green Tea DIETARY_SUPPLEMENT

Green tea capsules taken twice a day.

2

Placebo OTHER

Non-active "sugar pill".

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Interventions

Tea

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jennifer L Donovan, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Thomas W Uhde, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 18, 2018

Record last verified: 2009-07

Locations

US (1)