Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

Study Overview
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Brief Summary
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There has been an increase in the prevalance of type 2 diabetes in developed countries in recent years. The major contributing factors have been genetic predisposition, environmental factors, and unhealthy eating habits and stress. Adverse effects on cardiovascular and renal systems after prolonged hyperglycemia bring serious burden to patients, to their families and to the society. 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.

Official Title
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Effects Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients between 40-65 years of age will be eligible for the study Exclusion Criteria: Patients with cardiac, renal, liver disease and smokers will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>We planned to compare a study group of 60 subjects with a placebo group of 60 subjects | Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)<br>* 1 tablet/day for 3 months<br>* Other names: Comilac PomGT tablets;|
| Active Comparator: Group 2<br>We planned to compare a study group of 60 subjects with a placebo group of 60 subjects | Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)<br>* 1 tablet/day for 3 months<br>* Other names: Comilac PomGT tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment of type 2 diabetes by polyphenol containing antioxidants |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative stress, malondialdehyde, glutathione, diabetes, polyphenol containing antioxidants, diet rich in vegetables, weekly aerobic exercise