Athletic InjuriesNCT01875497
Effect of Vitis Vinifera Extract on Oxidative Stress, Inflamatory Biomarkers and Hormones in High Trained Subjects
A study testing grape fruit (vitis vinifera) extract in capsule with 205 mg in people with Athletic Injuries, run by Rio de Janeiro State University at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- grape fruit (vitis vinifera) extract in capsule with 205 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy physically active men
Who cannot join
- Diabetes, hypertension, obesity subjects, drug use
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20550900
M C Gonçalves, MD, 55 21 23340679 ext. 218, marianagoncalves.mg@gmail.com
M C Gonçalves, MD
About this study
Official title: Effect of Vitis Vinifera Extract on Oxidative Stress, Inflammatory Biomarkers and Hormones in High Trained Subjects After Resting and Intensive Physical Activity.
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.
Read the 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.
- Conditions
- Athletic Injuries
- Being tested
- grape fruit (vitis vinifera) extract in capsule with 205 mg
- Keywords
- athletes, polyphenols, nutrition, oxidative stress
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grape fruit (vitis vinifera) extract in capsule with 205 mgDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: grape fruit (vitis vinifera) extract in capsule with 205 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: This study will last 24 months (2013-2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josely Correa Koury, Rio de Janeiro State University
- Investigators
- J C Koury, PhD, Principal investigator, Instituto de Nutrição Universidade do Estado do Rio de Janeiro - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875497
- Sponsor's protocol ID
- E26-103.011/2012
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitis Vinifera Extract on Oxidative Stress, Inflammatory Biomarkers and Hormones in High Trained Subjects After Resting and Intensive Physical Activity.
- ClinicalTrials.gov ID
- NCT01875497
- Acronym / sponsor ID
- E26-103.011/2012
- Conditions
- Athletic Injuries
- Keywords
- athletes, polyphenols, nutrition, oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: grape fruit (vitis vinifera) extract in capsule with 205 mgBefore the exercise, the individuals intake only one capsule with 205 mg of the grape fruit extract in capsule with 205 mg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy physically active men
Key exclusion criteria (1 listed)
- Diabetes, hypertension, obesity subjects, drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| grape fruit (vitis vinifera) extract in capsule with 205 mgBefore 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 | Dietary Supplement |
Primary outcome
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)
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J C Koury, PhD principal investigator
Instituto de Nutrição Universidade do Estado do Rio de Janeiro - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing grape fruit (vitis vinifera) extract in capsule with 205 mg in people with Athletic Injuries, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M C G, MD (55 21 23340679 ext. 218, marianagoncalves.mg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.