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


Phase 2/Phase 3
35 Years
65 Years
Open (Enrolling)
Both
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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Assess the effects of green tea and FPP on the levels of C-reactive proteins

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Okezie I Aruoma, PhD DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Touro College of Pharmacy

Authority:

Mauritius: Ministry of Health and Quality of Life

Study ID:

FPP and TEA IN DIABETES

NCT ID:

NCT01248143

Start Date:

November 2010

Completion Date:

March 2011

Related Keywords:

  • 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
  • Green Tea
  • Fermented papaya preparation
  • Diabetes
  • Cardiovascular diseases
  • Atherosclerotic plaques
  • Glucose
  • Dietary supplements and functional foods
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Plaque, Atherosclerotic

Name

Location

Touro College of PharmacyNew York, New York  10027