Clinical trial NCT01248143: Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
Official title: Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: The Touro College and University System
Sponsor class: OTHER
Collaborators: name: University of Mauritius
name: Mauritius Cardiac Center
name: Mauritius Ministry of Health and Quality of Life
name: Osato Research Institute
name: Societe Uniniere de Bois Cheri
name: Mauritius Research Council
name: University of Vienna
First posted: 2010-11-25
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assess the effects of green tea and FPP on the levels of C-reactive proteins
timeFrame: 3 months
Secondary outcomes:
measure: Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Touro College of Pharmacy
state: New York
city: Vienna
country: Austria
facility: University of Vienna
city: Reduit
country: Mauritius
facility: University of Mauritius
Study officials:
affiliation: Touro College of Pharmacy
name: Okezie I Aruoma, PhD DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.