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

NCT ID: NCT01248143

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Green tea

Group Type EXPERIMENTAL

Green tea

Intervention Type DIETARY_SUPPLEMENT

9 gram per day

FPP

Group Type EXPERIMENTAL

FPP

Intervention Type DIETARY_SUPPLEMENT

2 sachets twice daily

Interventions

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Green tea

9 gram per day

Intervention Type DIETARY_SUPPLEMENT

FPP

2 sachets twice daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mauritius

OTHER

Sponsor Role collaborator

Mauritius Cardiac Center

UNKNOWN

Sponsor Role collaborator

Mauritius Ministry of Health and Quality of Life

UNKNOWN

Sponsor Role collaborator

Osato Research Institute

OTHER

Sponsor Role collaborator

Societe Uniniere de Bois Cheri

UNKNOWN

Sponsor Role collaborator

Mauritius Research Council

OTHER

Sponsor Role collaborator

University of Vienna

OTHER

Sponsor Role collaborator

The Touro College and University System

OTHER

Sponsor Role lead

Responsible Party

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Dr Okezie I Aruoma

Professor of Pharmaceutical and Biomedical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Okezie I Aruoma, PhD DSc

Role: PRINCIPAL_INVESTIGATOR

Touro College of Pharmacy

Locations

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Touro College of Pharmacy

New York, New York, United States

Site Status

University of Vienna

Vienna, , Austria

Site Status

University of Mauritius

Réduit, , Mauritius

Site Status

Countries

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United States Austria Mauritius

References

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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.

Reference Type BACKGROUND
PMID: 19963031 (View on PubMed)

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.

Reference Type RESULT
PMID: 22198621 (View on PubMed)

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.

Reference Type RESULT
PMID: 22330753 (View on PubMed)

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.

Reference Type RESULT
PMID: 24102055 (View on PubMed)

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.

Reference Type RESULT
PMID: 24316314 (View on PubMed)

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.

Reference Type RESULT
PMID: 24769427 (View on PubMed)

Other Identifiers

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FPP and TEA IN DIABETES

Identifier Type: -

Identifier Source: org_study_id