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

Athletic Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01875497
• Other study ID #: E26-103.011/2012
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 11, 2013
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2013
• Source: Rio de Janeiro State University
• Contact: M C G, MD
• Phone: 55 21 23340679
• Email: marianagoncalves.mg[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy physically active men

Exclusion Criteria:

• Diabetes, hypertension, obesity subjects, drug use

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Athletic Injuries

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade do Estado do Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes