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

The Touro College and University System

Status and phase: Completed; Phase 3; Phase 2

Conditions: Effects of Green Tea and FPP of Lipid Profiles in Diabetes; Assess the Effect of Green Tea on Diabetes; Effects of Green Tea and FPP on C-reactive Proteins; Assess the Effect of Fermented Papaya Pretration on Diabetes; Effect of Green Tea and FPP on Atheroma Formation

Treatments: Dietary Supplement: FPP; Dietary Supplement: Green tea

Study type: Interventional

Funder types: Other

Identifiers

NCT01248143

FPP and TEA IN DIABETES

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Green tea

Experimental group

Treatment:

Dietary Supplement: Green tea

FPP

Experimental group

Treatment:

Dietary Supplement: FPP