Effects of Polyphenol Containing Antioxidants on Oxidative Stress in Diabetic Patients

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)

• Registration Number: NCT00682149
• Lead Sponsor: Yeditepe University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-05
• Study Start: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Last Update Submitted: 2008-05-20
• Study First Posted: 2008-05-22
• Last Update Posted: 2008-05-22
• Primary Completion: 2008-07
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)	We planned to compare a study group of 60 subjects with a placebo group of 60 subjects
Group 1	PomGT (500 mg pomegranate extracts, 300 mg green tea and 60mg vitamin C)	We planned to compare a study group of 60 subjects with a placebo group of 60 subjects

Primary Outcome Measures

Name	Time	Method
Amelioration of antioxidative capacity in diabetic patients by polyphenol containig antioxidants	3 months

Secondary Outcome Measures

Name	Time	Method
treatment of type 2 diabetes by polyphenol containing antioxidants	3 months

Trial Locations

Locations (1)

Sisli Etfal Education and Research Hospital; 🇹🇷 Istanbul, Turkey