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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
Sponsor:
Collaborators:
University of Mauritius
Mauritius Cardiac Center
Mauritius Ministry of Health and Quality of Life
Osato Research Institute
Societe Uniniere de Bois Cheri
Mauritius Research Council
University of Vienna
Information provided by (Responsible Party):
Dr Okezie I Aruoma, The Touro College and University System

Study Description
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Brief Summary:
Type 2 diabetes is common in ethnic and, minority groups in developing and developed countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya preparation and green tea infusates in latent diabetes (individuals newly diagnosed as diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation end-products which play a role as proinflammatory mediators in gestational diabetes can accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction with high-affinity receptors located on monocytes and macrophages can enhance the production of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial, mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of cardiovascular complications. The clinical markers include C-reactive proteins (inflammation indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides, and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of diabetic nephropathy. A second phase of the study is expected to commence after the first 16 weeks in order to assess the ability of the dietary factors to modulate atheroma formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis of diabetes. This will be expected to last up to 3 years.

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Green tea Dietary Supplement: Green tea
9 gram per day
Experimental: FPP Dietary Supplement: FPP
2 sachets twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
The Touro College and University System
University of Mauritius
Mauritius Cardiac Center
Mauritius Ministry of Health and Quality of Life
Osato Research Institute
Societe Uniniere de Bois Cheri
Mauritius Research Council
University of Vienna
Investigators
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Principal Investigator: Okezie I Aruoma, PhD DSc Touro College of Pharmacy
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Dr Okezie I Aruoma, Professor of Pharmaceutical and Biomedical Sciences, The Touro College and University System
ClinicalTrials.gov Identifier: NCT01248143     History of Changes
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
Keywords provided by Dr Okezie I Aruoma, The Touro College and University System:
Green Tea
Fermented papaya preparation
Diabetes
Cardiovascular diseases
 Atherosclerotic plaques
Glucose
Dietary supplements and functional foods
Additional relevant MeSH terms:
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Diabetes Mellitus
Plaque, Atherosclerotic
Cardiovascular Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical