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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Rio de Janeiro State University

Current Primary Outcome: 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 [ Time Frame: This study will last 24 months (2013-2015) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Differences between body composition and microcirculation parameters in vitis vinifera extract supplemented and placebo subject before and after high intense training [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: This study will last 24 months (2013-2015) ]


Original Secondary Outcome: Same as current

Information By: Rio de Janeiro State University

Dates:
Date Received: June 5, 2013
Date Started: January 2013
Date Completion: December 2015
Last Updated: June 11, 2013
Last Verified: June 2013