Bipolar DisorderNCT00934908
Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
A study testing Green Tea in people with Bipolar Disorder and Schizophrenia, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- What is being tested?
- Green Tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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).
Read the 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.
- Conditions
- Bipolar Disorder, Schizophrenia
- Being tested
- Green Tea, Placebo
- Keywords
- Zyprexa®, Green Tea, ALL
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green TeaDietary supplement
Green tea capsules taken twice a day.
PlaceboOther
Non-active "sugar pill".
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Non-active "sugar pill" Receives: Other: Placebo |
| 2 | Active comparator | Green Tea Capsules Receives: Dietary Supplement: Green Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attenuation of weight and fat gain in patients initiating therapy with Zyprexa®
Measured: Weeks 1, 6 and 12
Secondary outcomes (1)
Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®.
Measured: Weeks 1, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Jennifer L Donovan, PhD, Principal investigator, Medical University of South CarolinaThomas W Uhde, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934908
- Sponsor's protocol ID
- Green Tea and Olanzapine
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine
- ClinicalTrials.gov ID
- NCT00934908
- Acronym / sponsor ID
- Green Tea and Olanzapine
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- Zyprexa®, Green Tea, ALL
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Mar 2009 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: PlaceboNon-active "sugar pill" |
| 2 | Active comparator | Dietary Supplement: Green TeaGreen Tea Capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green TeaGreen tea capsules taken twice a day. | Dietary supplement | 2 |
| PlaceboNon-active "sugar pill". | Other | 1 |
Primary outcome
Attenuation of weight and fat gain in patients initiating therapy with Zyprexa®
Time frame: Weeks 1, 6 and 12
1 secondary outcome
Attenuation of negative changes in the plasma lipid profile in patients initiating therapy with Zyprexa®.
Time frame: Weeks 1, 6 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Donovan, PhD principal investigator
Medical University of South Carolina
Thomas W Uhde, MD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Tea in people with Bipolar Disorder and Schizophrenia, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attenuation of weight and fat gain in patients initiating therapy with Zyprexa® (time frame: Weeks 1, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.