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

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

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.

Study Overview

• Status: Unknown
• Conditions: Athletic Injuries
• Intervention / Treatment: Dietary supplement: grape fruit (vitis vinifera) extract in capsule with 205 mg

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 Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M C G, MD; Phone Number: 218 55 21 23340679; Email: marianagoncalves.mg@gmail.com

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20550900
      • Recruiting
      • Universidade do Estado do Rio de Janeiro
      • Contact: M C Gonçalves, MD; Phone Number: 218 55 21 23340679; Email: marianagoncalves.mg@gmail.com
      • Sub-Investigator: M C Gonçalves, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy physically active men

Exclusion Criteria:

• Diabetes, hypertension, obesity subjects, drug use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Supplement; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Investigators: Principal Investigator: J C Koury, PhD, Instituto de Nutrição Universidade do Estado do Rio de Janeiro - Brazil

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 11, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: athletes, polyphenols, nutrition, oxidative stress
• Additional Relevant MeSH Terms: Wounds and Injuries; Athletic Injuries
• Other Study ID Numbers: E26-103.011/2012