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

Primary Purpose

Athletic Injuries

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

grape fruit (vitis vinifera) extract in capsule with 205 mg

About this trial

This is an interventional basic science trial for Athletic Injuries focused on measuring athletes, polyphenols, nutrition, oxidative stress

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy physically active men

Exclusion Criteria:

Diabetes, hypertension, obesity subjects, drug use

Sites / Locations

Universidade do Estado do Rio de JaneiroRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary Supplement

Arm Description

Before the exercise, the individuals intake only one capsule with 205 mg of the grape fruit extract in capsule with 205 mg.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Differences between body composition and microcirculation parameters in vitis vinifera extract supplemented and placebo subject before and after high intense training

Differences between oxidative stress biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training

Differences between inflammation biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training

Differences between adipokines in vitis vinifera extract supplemented and placebo subject before and after high intense training

Full Information

NCT ID

NCT01875497

First Posted

June 5, 2013

Last Updated

June 11, 2013

Sponsor

Rio de Janeiro State University

1. Study Identification

Unique Protocol Identification Number

NCT01875497

Brief Title

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

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rio de Janeiro State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Athletic Injuries

Keywords

athletes, polyphenols, nutrition, oxidative stress

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dietary Supplement

Arm Type

Experimental

Arm Description

Before the exercise, the individuals intake only one capsule with 205 mg of the grape fruit extract in capsule with 205 mg.

Intervention Type

Dietary Supplement

Intervention Name(s)

grape fruit (vitis vinifera) extract in capsule with 205 mg

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame