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

NCT01248143 | Completed Phase 2

• 1 other identifier: FPP and TEA IN DIABETES
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Green Tea; Fermented papaya preparation; Diabetes; Cardiovascular diseases; Atherosclerotic plaques; Glucose; Dietary supplements and functional foods

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes

  3 years

Study Arms (2)

Green tea

EXPERIMENTAL

Dietary Supplement: Green tea

FPP

EXPERIMENTAL

Dietary Supplement: FPP

Interventions

Green tea DIETARY_SUPPLEMENT

9 gram per day

Green tea

FPP DIETARY_SUPPLEMENT

2 sachets twice daily

FPP

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals at risk of diabetes 35-65 years of age male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• The Touro College and University System: lead
• University of Mauritius: collaborator
• Mauritius Cardiac Center: collaborator
• Mauritius Ministry of Health and Quality of Life: collaborator
• Osato Research Institute: collaborator
• Societe Uniniere de Bois Cheri: collaborator
• Mauritius Research Council: collaborator
• University of Vienna: collaborator

Study Sites (3)

Touro College of Pharmacy

New York, New York, 10027, United States

Location

University of Vienna

Vienna, Austria

Location

University of Mauritius

Réduit, Mauritius

Location

Related Publications (6)

• Bahorun T, Luximon-Ramma A, Gunness TK, Sookar D, Bhoyroo S, Jugessur R, Reebye D, Googoolye K, Crozier A, Aruoma OI. Black tea reduces uric acid and C-reactive protein levels in humans susceptible to cardiovascular diseases. Toxicology. 2010 Nov 28;278(1):68-74. doi: 10.1016/j.tox.2009.11.024. Epub 2009 Dec 4.

  PMID: 19963031 BACKGROUND

• Bahorun T, Luximon-Ramma A, Neergheen-Bhujun VS, Gunness TK, Googoolye K, Auger C, Crozier A, Aruoma OI. The effect of black tea on risk factors of cardiovascular disease in a normal population. Prev Med. 2012 May;54 Suppl:S98-102. doi: 10.1016/j.ypmed.2011.12.009. Epub 2011 Dec 16.

  PMID: 22198621 RESULT

• Somanah J, Aruoma OI, Gunness TK, Kowelssur S, Dambala V, Murad F, Googoolye K, Daus D, Indelicato J, Bourdon E, Bahorun T. Effects of a short term supplementation of a fermented papaya preparation on biomarkers of diabetes mellitus in a randomized Mauritian population. Prev Med. 2012 May;54 Suppl:S90-7. doi: 10.1016/j.ypmed.2012.01.014. Epub 2012 Feb 11.

  PMID: 22330753 RESULT

• Toolsee NA, Aruoma OI, Gunness TK, Kowlessur S, Dambala V, Murad F, Googoolye K, Daus D, Indelicato J, Rondeau P, Bourdon E, Bahorun T. Effectiveness of green tea in a randomized human cohort: relevance to diabetes and its complications. Biomed Res Int. 2013;2013:412379. doi: 10.1155/2013/412379. Epub 2013 Sep 12.

  PMID: 24102055 RESULT

• Somanah J, Bourdon E, Rondeau P, Bahorun T, Aruoma OI. Relationship between fermented papaya preparation supplementation, erythrocyte integrity and antioxidant status in pre-diabetics. Food Chem Toxicol. 2014 Mar;65:12-7. doi: 10.1016/j.fct.2013.11.050. Epub 2013 Dec 5.

  PMID: 24316314 RESULT

• Aruoma OI, Somanah J, Bourdon E, Rondeau P, Bahorun T. Diabetes as a risk factor to cancer: functional role of fermented papaya preparation as phytonutraceutical adjunct in the treatment of diabetes and cancer. Mutat Res. 2014 Oct;768:60-8. doi: 10.1016/j.mrfmmm.2014.04.007. Epub 2014 Apr 24.

  PMID: 24769427 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Plaque, Atherosclerotic

Interventions

Tea

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Okezie I Aruoma, PhD DSc

  Touro College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmaceutical and Biomedical Sciences

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

US (1); MA (1); AU (1)