Clinical trial NCT01875497: Effect of Vitis Vinifera Extract on Oxidative Stress, Inflamatory Biomarkers and Hormones in High Trained Subjects
Official title: Effect of Vitis Vinifera Extract on Oxidative Stress, Inflammatory Biomarkers and Hormones in High Trained Subjects After Resting and Intensive Physical Activity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Athletic Injuries
Keywords: athletes, polyphenols, nutrition, oxidative stress
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy physically active men

Exclusion Criteria:

* Diabetes, hypertension, obesity subjects, drug use

Primary outcomes:
measure: 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
timeFrame: This study will last 24 months (2013-2015)
Secondary outcomes:
measure: Differences between body composition and microcirculation parameters in vitis vinifera extract supplemented and placebo subject before and after high intense training
timeFrame: This study will last 24 months (2013-2015)
measure: Differences between oxidative stress biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training
timeFrame: This study will last 24 months (2013-2015)
measure: Differences between inflammation biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training
timeFrame: This study will last 24 months (2013-2015)
measure: Differences between adipokines in vitis vinifera extract supplemented and placebo subject before and after high intense training
timeFrame: This study will last 24 months (2013-2015)
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade do Estado do Rio de Janeiro
state: RJ
Study officials:
affiliation: Instituto de Nutrição Universidade do Estado do Rio de Janeiro - Brazil
name: J C Koury, PhD
role: PRINCIPAL_INVESTIGATOR
References: