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

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.

Conditions

• 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

Interventions

DIETARY_SUPPLEMENT

Green tea

9 gram per day

DIETARY_SUPPLEMENT

FPP

2 sachets twice daily

Sponsors & Collaborators

• University of Mauritius

  collaborator OTHER

• Mauritius Cardiac Center

  collaborator UNKNOWN

• Mauritius Ministry of Health and Quality of Life

  collaborator UNKNOWN

• Osato Research Institute

  collaborator OTHER

• Societe Uniniere de Bois Cheri

  collaborator UNKNOWN

• Mauritius Research Council

  collaborator OTHER

• University of Vienna

  collaborator OTHER

• The Touro College and University System

  lead OTHER

Principal Investigators

• Okezie I Aruoma, PhD DSc · Touro College of Pharmacy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States
• Austria
• Mauritius

Study Locations