Effect of Vitis Vinifera Extract on Oxidative Stress, Inflamatory Biomarkers and Hormones in High Trained Subjects

Study Overview
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Brief Summary
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There is evidence that intense physical activity has a potential effect on thrombotic events due to catecholamine release. The hormones leptin and adiponectin have been used as markers of cardiovascular risk, but they are few and contradictory studies that relate physical training intensity and duration of high plasma concentrations of these hormones. The use of antioxidants, such as proanthocyanidins present in grapes, may help in reducing the undesirable effects of intense training.

Detailed Description
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Fifty four Brazilian healthy military without hyperglycemia, diabetes mellitus and endocrine disease were enrolled in this study. All subjects were high physically military trained. The Ethical Committee of the Universidade do Estado do Rio de Janeiro in Brazil (COEP008/2011) approved the study protocol. Informed consent was obtained from each subject after explanation of purpose and risks of all procedures used.

Official Title
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Effect of Vitis Vinifera Extract on Oxidative Stress, Inflammatory Biomarkers and Hormones in High Trained Subjects After Resting and Intensive Physical Activity.

Conditions
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Athletic Injuries

Intervention / Treatment
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* Dietary Supplement: grape fruit (vitis vinifera) extract in capsule with 205 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy physically active men Exclusion Criteria: Diabetes, hypertension, obesity subjects, drug use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement<br>Before the exercise, the individuals intake only one capsule with 205 mg of the grape fruit extract in capsule with 205 mg. | Dietary Supplement: grape fruit (vitis vinifera) extract in capsule with 205 mg<br>* Before the exercise the indivuduals intake only one capsule of the grape fruit extract with 205 mg. This dosage is free of contraindications according to others studies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the changes of oxidative stress, microcirculation parameters, inflammation biomarkers and plasma adipokines in vitis vinifera extract supplemented and placebo subject before and after high intense training |  | This study will last 24 months (2013-2015) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between body composition and microcirculation parameters in vitis vinifera extract supplemented and placebo subject before and after high intense training |  | This study will last 24 months (2013-2015) | 
| Differences between oxidative stress biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training |  | This study will last 24 months (2013-2015) | 
| Differences between inflammation biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training |  | This study will last 24 months (2013-2015) | 
| Differences between adipokines in vitis vinifera extract supplemented and placebo subject before and after high intense training |  | This study will last 24 months (2013-2015) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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athletes, polyphenols, nutrition, oxidative stress