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

NCT ID: NCT01875497

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Athletic Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dietary Supplement

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy physically active men

Exclusion Criteria

* Diabetes, hypertension, obesity subjects, drug use
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

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Josely Correa Koury

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J C Koury, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Nutrição Universidade do Estado do Rio de Janeiro - Brazil

Locations

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Universidade do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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M C G, MD

Role: CONTACT

55 21 23340679 ext. 218

Facility Contacts

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M C Gonçalves, MD

Role: primary

55 21 23340679 ext. 218

Other Identifiers

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E26-103.011/2012

Identifier Type: -

Identifier Source: org_study_id

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