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

NCT01875497 | Unknown DMC

• 1 other identifier: E26-103.011/2012
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Athletic Injuries

Keywords

athletes, polyphenols, nutrition, oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (1)

Dietary Supplement

EXPERIMENTAL

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

Interventions

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

Dietary Supplement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy physically active men

You may not qualify if:

• Diabetes, hypertension, obesity subjects, drug use

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

Universidade do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20550900, Brazil

RECRUITING

MeSH Terms

Conditions

Athletic Injuries

Interventions

whole grape extract; Capsules

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• J C Koury, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M C G, MD

CONTACT

55 21 23340679; marianagoncalves.mg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 11, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

BR (1)