Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Touro College.
Recruitment status was  Active, not recruiting
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
Medical University of Vienna
Information provided by:
Touro College
ClinicalTrials.gov Identifier:
NCT01248143
First received: November 24, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases

Resource links provided by NLM:


Further study details as provided by Touro College:

Primary Outcome Measures:
  • Assess the effects of green tea and FPP on the levels of C-reactive proteins [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: November 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Green tea Dietary Supplement: Green tea
9 gram per day
Experimental: FPP Dietary Supplement: FPP
2 sachets twice daily

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248143

Locations
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
Touro College
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
Medical University of Vienna
Investigators
Principal Investigator: Okezie I Aruoma, PhD DSc Touro College of Pharmacy
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Okezie I Aruoma, Professor, Touro College of Pharmacy
ClinicalTrials.gov Identifier: NCT01248143     History of Changes
Other Study ID Numbers: FPP and TEA IN DIABETES
Study First Received: November 24, 2010
Last Updated: November 24, 2010
Health Authority: Mauritius: Ministry of Health and Quality of Life

Keywords provided by Touro College:
Green Tea
Fermented papaya preparation
Diabetes
Cardiovascular diseases
Atherosclerotic plaques
Glucose
Dietary supplements and functional foods

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Plaque, Atherosclerotic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014