Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
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ClinicalTrials.gov Identifier: NCT01248143 |
Recruitment Status :
Completed
First Posted : November 25, 2010
Last Update Posted : November 17, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Assess the Effect of Green Tea on Diabetes Assess the Effect of Fermented Papaya Pretration on Diabetes Effects of Green Tea and FPP on C-reactive Proteins Effects of Green Tea and FPP of Lipid Profiles in Diabetes Effect of Green Tea and FPP on Atheroma Formation | Dietary Supplement: Green tea Dietary Supplement: FPP | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Green tea |
Dietary Supplement: Green tea
9 gram per day |
Experimental: FPP |
Dietary Supplement: FPP
2 sachets twice daily |
- Assess the effects of green tea and FPP on the levels of C-reactive proteins [ Time Frame: 3 months ]The pathophysiology of atherosclerosis and other cardiovascular events have associated inflammatory processes. The levels of plasma high-sensitivity (hs) C-Reactive Protein, an acute phase reactant produced in the liver, known to rise in inflammatory reactions are widely suggested to be a predictor of coronary events; and increased uric acid levels (hyperuricemia) are considered to be a risk factor in many clinical conditions including hypertension, cardiovascular events, diabetes mellitus, stroke, and metabolic syndrome.
- Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes [ Time Frame: 3 years ]Carotid artery angioplasty and stenting has been proposed as an alternative therapy for patients requiring treatment of carotid artery stenosis as opposed to the "gold standard" surgical intervention, carotid endarterectomy. The second phase of the study will investigate the possible role of green tea and fermented papaya preparation in modulating the risk of stroke by assessing the extent of atheroma using both echocardiography and CT angiography. Patients will be on medication and the therapeutic outcome will be assessed.

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Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248143
United States, New York | |
Touro College of Pharmacy | |
New York, New York, United States, 10027 | |
Austria | |
University of Vienna | |
Vienna, Austria | |
Mauritius | |
University of Mauritius | |
Reduit, Mauritius |
Principal Investigator: | Okezie I Aruoma, PhD DSc | Touro College of Pharmacy |
Other Publications:
Responsible Party: | Dr Okezie I Aruoma, Professor of Pharmaceutical and Biomedical Sciences, The Touro College and University System |
ClinicalTrials.gov Identifier: | NCT01248143 |
Other Study ID Numbers: |
FPP and TEA IN DIABETES |
First Posted: | November 25, 2010 Key Record Dates |
Last Update Posted: | November 17, 2014 |
Last Verified: | November 2014 |
Green Tea Fermented papaya preparation Diabetes Cardiovascular diseases |
Atherosclerotic plaques Glucose Dietary supplements and functional foods |
Cardiovascular Diseases Diabetes Mellitus Plaque, Atherosclerotic Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pathological Conditions, Anatomical |