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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Green tea
FPP
Sponsored by
The Touro College and University System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Assess the Effect of Green Tea on Diabetes focused on measuring Green Tea, Fermented papaya preparation, Diabetes, Cardiovascular diseases, Atherosclerotic plaques, Glucose, Dietary supplements and functional foods

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Touro College of Pharmacy
  • University of Vienna
  • University of Mauritius

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Green tea

FPP

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes
Carotid artery angioplasty and stenting has been proposed as an alternative therapy for patients requiring treatment of carotid artery stenosis as opposed to the "gold standard" surgical intervention, carotid endarterectomy. The second phase of the study will investigate the possible role of green tea and fermented papaya preparation in modulating the risk of stroke by assessing the extent of atheroma using both echocardiography and CT angiography. Patients will be on medication and the therapeutic outcome will be assessed.

Full Information

First Posted
November 24, 2010
Last Updated
November 14, 2014
Sponsor
The Touro College and University System
Collaborators
University of Mauritius, Mauritius Cardiac Center, Mauritius Ministry of Health and Quality of Life, Osato Research Institute, Societe Uniniere de Bois Cheri, Mauritius Research Council, University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01248143
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Touro College and University System
Collaborators
University of Mauritius, Mauritius Cardiac Center, Mauritius Ministry of Health and Quality of Life, Osato Research Institute, Societe Uniniere de Bois Cheri, Mauritius Research Council, University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green tea
Arm Type
Experimental
Arm Title
FPP
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea
Intervention Description
9 gram per day
Intervention Type
Dietary Supplement
Intervention Name(s)
FPP
Intervention Description
2 sachets twice daily
Primary Outcome Measure Information:
Title
Assess the effects of green tea and FPP on the levels of C-reactive proteins
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes
Description
Carotid artery angioplasty and stenting has been proposed as an alternative therapy for patients requiring treatment of carotid artery stenosis as opposed to the "gold standard" surgical intervention, carotid endarterectomy. The second phase of the study will investigate the possible role of green tea and fermented papaya preparation in modulating the risk of stroke by assessing the extent of atheroma using both echocardiography and CT angiography. Patients will be on medication and the therapeutic outcome will be assessed.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Okezie I Aruoma, PhD DSc
Organizational Affiliation
Touro College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Touro College of Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
University of Vienna
City
Vienna
Country
Austria
Facility Name
University of Mauritius
City
Reduit
Country
Mauritius

12. IPD Sharing Statement

Citations:
PubMed Identifier
19963031
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.
Results Reference
background
PubMed Identifier
22198621
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.
Results Reference
result
PubMed Identifier
22330753
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.
Results Reference
result
PubMed Identifier
24102055
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.
Results Reference
result
PubMed Identifier
24316314
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.
Results Reference
result
PubMed Identifier
24769427
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.
Results Reference
result

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

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