Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions

Study Overview
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Brief Summary
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Aging is associated with increased risk of various diseases, and much attention is given to the use of natural products (like herbs) and 'functional food', such as teas, for healthy aging. The body is continuously exposed to potentially damaging agents (known as free radicals). The imbalance between the amount of free radicals and that of antioxidants in the body is known as oxidative stress. It is known that Type 2 DM is a state of increased oxidative stress, which is thought to lead to many long term complications of Type 2 DM, such as heart disease, vision problems and kidney failure. Antioxidant therapy, including increased consumption of antioxidant rich foods and beverages such as green tea, has been suggested as possibly beneficial in lowering the risk of these complications. The purpose of this study is to examine the effects of regular intake of green tea on indices of oxidative stress and antioxidant defense within cells, plasma and urine so as to investigate if regular intake of green tea can be recommended for health promotion.

Official Title
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Orthomolecular Mechanisms of Health Effects of Antioxidant Rich Diets, With Focus on Green Tea (Camellia Sinensis), DNA Protection and Key Biochemical Products/Effects of the Antioxidant Response Element

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Green tea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM subjects Genotyped for polymorphism in the heme-oxygenase gene promoter region to be homozygous for long (> 26) or short (< 24) GT repeats Exclusion Criteria: smokers have suffered DM related complication already taking antioxidant or herbal supplements

Ages Eligible for Study
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Maximum Age: 70 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Green tea|Each subject will take either green tea (2%w/v), or water, twice a day for twelve weeks, then wash out for twelve weeks and swap onto the other treatment (either green tea of water) for another twelve weeks in addition to their normal food and beverage intake|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of Antioxidant Response Element After Consumption of Green Tea | Biomarkers of antioxidant and oxidant balance, antioxidant response element activation (through gene and protein expression studies and plasma biomarkers) will be determined pre and post consumption of green tea | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Antioxidant oxidant balance, Activation of Antioxidant Response Element