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

November 14, 2014 updated by: Dr Okezie I Aruoma, The Touro College and University System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • University of Vienna
  • Mauritius
      • Reduit, Mauritius
        • University of Mauritius
  • United States
    • New York
      • New York, New York, United States, 10027
        • Touro College of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Green tea
Dietary supplement: Green tea
9 gram per day
Experimental: FPP
Dietary supplement: FPP
2 sachets twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Touro College and University System

Collaborators

University of Vienna
Osato Research Institute
University of Mauritius
Mauritius Research Council
Mauritius Cardiac Center
Mauritius Ministry of Health and Quality of Life
Societe Uniniere de Bois Cheri

Investigators

  • Principal Investigator: Okezie I Aruoma, PhD DSc, Touro College of Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPP and TEA IN DIABETES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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