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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01248143 |
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Date of registration:
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24/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
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Scientific title:
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Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01248143 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Austria
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Mauritius
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United States
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Contacts
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Name:
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Okezie I Aruoma, PhD DSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Touro College of Pharmacy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Individuals at risk of diabetes 35-65 years of age male or female
Exclusion Criteria:
- Smokers or those who have stopped smoking 6 months before the study
- Daily alcoholic intake exceeding 4 standard drinks
- Post menopausal women currently under hormone replacement treatment
- Hypertension (>140/90 mm Hg)
- individuals outside the age range 35-60
Age minimum:
35 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Assess the Effect of Fermented Papaya Pretration on Diabetes
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Effects of Green Tea and FPP of Lipid Profiles in Diabetes
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Effect of Green Tea and FPP on Atheroma Formation
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Assess the Effect of Green Tea on Diabetes
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Effects of Green Tea and FPP on C-reactive Proteins
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Intervention(s)
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Dietary Supplement: Green tea
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Dietary Supplement: FPP
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Primary Outcome(s)
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Assess the effects of green tea and FPP on the levels of C-reactive proteins
[Time Frame: 3 months]
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Secondary Outcome(s)
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Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes
[Time Frame: 3 years]
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Secondary ID(s)
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FPP and TEA IN DIABETES
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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