Assess the Effect of Green Tea on DiabetesPhase 2/3NCT01248143
Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
A Phase 2/3 study testing Green tea and FPP in people with Assess the Effect of Green Tea on Diabetes and Assess the Effect of Fermented Papaya Pretration on Diabetes, run by The Touro College and University System at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Green tea and FPP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2010to Mar 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals at risk of diabetes 35-65 years of age male or female
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
- Being tested
- Green tea, FPP
- Keywords
- Green Tea, Fermented papaya preparation, Diabetes, Cardiovascular diseases, Atherosclerotic plaques, Glucose, Dietary supplements and functional foods
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
9 gram per day
FPPDietary supplement
2 sachets twice daily
| Study group | Role | What they receive |
|---|---|---|
| Green tea | Experimental | Not described Receives: Dietary Supplement: Green tea |
| FPP | Experimental | Not described Receives: Dietary Supplement: FPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Assess the Effect of Green Tea on DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Touro College and University System
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr Okezie I Aruoma, The Touro College and University System
- Investigators
- Okezie I Aruoma, PhD DSc, Principal investigator, Touro College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248143
- Sponsor's protocol ID
- FPP and TEA IN DIABETES
- Status last verified
- Nov 2014
- First submitted
- 24 Nov 2010
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19963031Bahorun 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.
PubMed 22198621Somanah 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.
PubMed 22330753Toolsee 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.
PubMed 24102055Somanah 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.
PubMed 24316314Aruoma 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.
PubMed 24769427
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT01248143
- Acronym / sponsor ID
- FPP and TEA IN DIABETES
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Touro College and University SystemUniversity, hospital or other
- 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
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea | Experimental | Dietary Supplement: Green tea |
| FPP | Experimental | Dietary Supplement: FPP |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals at risk of diabetes 35-65 years of age male or female
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea9 gram per day | Dietary supplement | Green tea |
| FPP2 sachets twice daily | Dietary supplement | FPP |
Primary outcome
Assess the effects of green tea and FPP on the levels of C-reactive proteins
Time frame: 3 months
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.
1 secondary outcome
Assess the effect of green tea and fermented papaya preparation on development of atheroma and drug therapy outcomes
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Background: PubMed 19963031Bahorun 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 publication: PubMed 22198621Bahorun 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 publication: PubMed 22330753Somanah 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 publication: PubMed 24102055Toolsee 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 publication: PubMed 24316314Somanah 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 publication: PubMed 24769427Aruoma 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Okezie I Aruoma, PhD DSc principal investigator
Touro College of Pharmacy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Green tea and FPP in people with Assess the Effect of Green Tea on Diabetes and Assess the Effect of Fermented Papaya Pretration on Diabetes, run by The Touro College and University System at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Austria, Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effects of green tea and FPP on the levels of C-reactive proteins (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248143, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.