Trial record 3 of 9 for:    Open Studies | "Athletic Injuries"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Rio de Janeiro State University
Sponsor:
Information provided by (Responsible Party):
Josely Correa Koury, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01875497
First received: June 5, 2013
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Athletic Injuries
Dietary Supplement: grape fruit (vitis vinifera) extract in capsule with 205 mg

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Vitis Vinifera Extract on Oxidative Stress, Inflammatory Biomarkers and Hormones in High Trained Subjects After Resting and Intensive Physical Activity.

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

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 [ Time Frame: This study will last 24 months (2013-2015) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Differences between body composition and microcirculation parameters in vitis vinifera extract supplemented and placebo subject before and after high intense training [ Time Frame: This study will last 24 months (2013-2015) ] [ Designated as safety issue: Yes ]
  • Differences between oxidative stress biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training [ Time Frame: This study will last 24 months (2013-2015) ] [ Designated as safety issue: Yes ]
  • Differences between inflammation biomarkers in vitis vinifera extract supplemented and placebo subject before and after high intense training [ Time Frame: This study will last 24 months (2013-2015) ] [ Designated as safety issue: Yes ]
  • Differences between adipokines in vitis vinifera extract supplemented and placebo subject before and after high intense training [ Time Frame: This study will last 24 months (2013-2015) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy physically active men

Exclusion Criteria:

  • Diabetes, hypertension, obesity subjects, drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875497

Contacts
Contact: M C G, MD 55 21 23340679 ext 218 marianagoncalves.mg@gmail.com

Locations
Brazil
Universidade do Estado do Rio de Janeiro Recruiting
Rio de Janeiro, RJ, Brazil, 20550900
Contact: M C Gonçalves, MD    55 21 23340679 ext 218    marianagoncalves.mg@gmail.com   
Sub-Investigator: M C Gonçalves, MD         
Sponsors and Collaborators
Rio de Janeiro State University
Investigators
Principal Investigator: J C Koury, PhD Instituto de Nutrição Universidade do Estado do Rio de Janeiro - Brazil
  More Information

No publications provided

Responsible Party: Josely Correa Koury, PhD, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01875497     History of Changes
Other Study ID Numbers: E26-103.011/2012
Study First Received: June 5, 2013
Last Updated: June 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Rio de Janeiro State University:
athletes, polyphenols, nutrition, oxidative stress

Additional relevant MeSH terms:
Athletic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014