Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients
NCT ID: NCT00682149
Last Updated: 2008-05-22
Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2008-05-31
2008-10-31
Brief Summary
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Oxidative stress has been defined as the imbalance between the production of reactive oxygen molecules and antioxidant protective molecules. It has been claimed that oxidative stress that the organism is exposed to and disturbance in anti-oxidant mechanisms have been important in the initiation of diabetes and its complications. Malondialdehyde is the final product of lipid peroxidation and it is an aldehyde as well. It has been accepted that malondialdehyde has been a biomarker in measuring oxidative stress.
Type 2 diabetic people who are between 40 -65 years of age will be the subjects of our study. The levels of fasting glucose, HbA1c, LDL, triglyceride, AST and ALT and also malondialdehyte, hydrogen peroxide and oxidative stress will be determined in patients blood after making them consume a 1500 calory standard diet for 2 weeks, The patients will be randomly divided into two grouos at the end of the two weeks. Group 1 will take placebo in addition to the diet, Group 2 will receive polyphenol containing capsules with pomegranate extract (500 mg), green tea extract (300 mg) and a little bit of (60 mg) vitamin C for three months. At the end of three months the measurement of biochemical parameters will be repeated.
Patients with cardiac, renal, liver disease and smokers will be excluded from the study.
Patients in both groups will have a diet rich in vegetables, three servings of fruit, maximum three slices of bread with a total calory of 1500.
In addition to these, both groups will have a weekly aerobic exercise regimen of 150 minutes conducted after breakfast.
The biochemical results of the two groups will be compared at the end of the experiment and they will be statistically evaluated.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
We planned to compare a study group of 60 subjects with a placebo group of 60 subjects
PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)
1 tablet/day for 3 months
Group 2
We planned to compare a study group of 60 subjects with a placebo group of 60 subjects
PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)
1 tablet/day for 3 months
Interventions
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PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)
1 tablet/day for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
65 Years
ALL
No
Sponsors
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Yeditepe University Hospital
OTHER
Responsible Party
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Yeditepe University Medical Faculty, Family Medicine Department
Principal Investigators
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Aysen Fenercioglu, Assist Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Yeditepe University Medical Faculty, Family medicine Department
Locations
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Sisli Etfal Education and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Tayyibe Saler, Dr
Role: primary
Aysen Fenercioglu, Assist Prof. Dr.
Role: backup
Other Identifiers
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DM2-AOC
Identifier Type: -
Identifier Source: org_study_id