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

Not Applicable

• Conditions: Athletic Injuries
• Interventions: Dietary Supplement: grape fruit (vitis vinifera) extract in capsule with 205 mg

• Registration Number: NCT01875497
• Lead Sponsor: Rio de Janeiro State University

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-06
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 55

Inclusion Criteria

• Healthy physically active men

Exclusion Criteria

• Diabetes, hypertension, obesity subjects, drug use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary Supplement	grape fruit (vitis vinifera) extract in capsule with 205 mg	Before the exercise, the individuals intake only one capsule with 205 mg of the grape fruit extract in capsule with 205 mg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 adipokines 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 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)

Trial Locations

Locations (1)

Universidade do Estado do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil