Oxidative StressNCT03186573
Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes
A study testing Grape juice and Maltodextrin in people with Oxidative Stress and Muscle Fatigue, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Muscle Fatigue, Polyphenol
- What is being tested?
- Grape juice and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 11 May 2017to 17 Aug 2017
- 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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Judo athletes, federated, who hold state, federal and international competitions of both sexes, aged between 15 and 24 years and any weight category of the sport, except free weight.
Who cannot join
- Recent injury (last 3 months) that prevents training or competition;
- Food restriction on grape juice;
- Being in the phase of fast weight loss in pre competition..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes: A Randomized Clinical Trial
This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling simulations will be performed on 3 different days.
Read the detailed description
Grape juice has a high concentration of phenolic compounds and is capable of modulating biochemical parameters and oxidative stress. By naturally containing carbohydrates grape juice can help acutely minimize fatigue during exercise as well as long-term oxidative stress parameters in athletes. This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling simulations will be performed on 3 different days. Each exercise session will consist of four 7-minute bouts, with 14-minute rest between them. The athletes will perform a first fight simulation without ingestion of any beverage (control group 1), and then will be randomized to determine the order of participation in the groups: maltodextrin (group 2 placebo) and grape juice (intervention group 3). Analyzes of oxidative stress; Muscle strength and fatigue; Perceived effort rate; Lactate; Heart rate; Analysis of food consumption and body composition.Two-way ANOVA will be used to evaluate the relation of the intervention and physical exercise, besides parameters of strength and fatigue. The level of significance adopted will be 5% and for the analysis, the SPSS summer 23 statistical program will be used.
- Being tested
- Grape juice, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape juiceDietary supplement
400ml diary of grape juice
MaltodextrinDietary supplement
400ml diary of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The athletes will not receive any drink and will do the simulations of the fight. |
| Intervention group | Active comparator | (Intervention, grape juice) - athletes will receive 400 ml per day of grape juice (containing 66g of carbohydrates) for 14 days and will do the fight simulations. Receives: Dietary Supplement: Grape juice |
| Placebo Group | Placebo comparator | (Placebo, grape-flavored maltodextrin carbohydrate) - athletes will receive400ml of drink daily with 66g of maltodextrin for 14 days and will do the fight simulations; The amount of maltodextrin is equal to the amount of carbohydrate present in grape juice. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress In Blood Collection
A disturbance in the prooxidant-antioxidant balance in favor of the former, leading to potential damage.
Measured: 15 days
Secondary outcomes (1)
Borg in scale.
Specific to muscle fatigue, a state arrived at through prolonged and strong contraction of a muscle. Studies in athletes during prolonged submaximal exercise have shown that muscle fatigue increases in almost direct proportion to the rate of muscle glycogen depletion. Muscle fatigue in short-term maximal exercise is associated with oxygen lack and an increased level of blood and muscle lactic acid, and an accompanying increase in hydrogen-ion concentration in the exercised muscle.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start11 May 2017
- Primary completion22 Jun 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Júlia Vieira da Cunha Goulart, Federal University of Health Science of Porto Alegre
- Investigators
- Cláudia Dornelles Schneider, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186573
- Sponsor's protocol ID
- UFCSPAPortoAlegre
- Status last verified
- Sep 2017
- First submitted
- 10 Jun 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03186573
- Acronym / sponsor ID
- UFCSPAPortoAlegre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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.
This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling simulations will be performed on 3 different days.
Detailed description
Grape juice has a high concentration of phenolic compounds and is capable of modulating biochemical parameters and oxidative stress. By naturally containing carbohydrates grape juice can help acutely minimize fatigue during exercise as well as long-term oxidative stress parameters in athletes. This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling simulations will be performed on 3 different days. Each exercise session will consist of four 7-minute bouts, with 14-minute rest between them. The athletes will perform a first fight simulation without ingestion of any beverage (control group 1), and then will be randomized to determine the order of participation in the groups: maltodextrin (group 2 placebo) and grape juice (intervention group 3). Analyzes of oxidative stress; Muscle strength and fatigue; Perceived effort rate; Lactate; Heart rate; Analysis of food consumption and body composition.Two-way ANOVA will be used to evaluate the relation of the intervention and physical exercise, besides parameters of strength and fatigue. The level of significance adopted will be 5% and for the analysis, the SPSS summer 23 statistical program will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The athletes will not receive any drink and will do the simulations of the fight. |
| Intervention group | Active comparator | Dietary Supplement: Grape juice(Intervention, grape juice) - athletes will receive 400 ml per day of grape juice (containing 66g of carbohydrates) for 14 days and will do the fight simulations. |
| Placebo Group | Placebo comparator | Dietary Supplement: Maltodextrin(Placebo, grape-flavored maltodextrin carbohydrate) - athletes will receive400ml of drink daily with 66g of maltodextrin for 14 days and will do the fight simulations; The amount of maltodextrin is equal to the amount of carbohydrate present in grape juice. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Judo athletes, federated, who hold state, federal and international competitions of both sexes, aged between 15 and 24 years and any weight category of the sport, except free weight.
Key exclusion criteria (3 listed)
- Recent injury (last 3 months) that prevents training or competition;
- Food restriction on grape juice;
- Being in the phase of fast weight loss in pre competition..
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 juice400ml diary of grape juice | Dietary supplement | Intervention group |
| Maltodextrin400ml diary of maltodextrin | Dietary supplement | Placebo Group |
Primary outcome
Oxidative stress In Blood Collection
Time frame: 15 days
A disturbance in the prooxidant-antioxidant balance in favor of the former, leading to potential damage.
1 secondary outcome
Borg in scale.
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Cláudia Dornelles Schneider principal investigator
Federal University of Health Science of Porto Alegre
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 juice and Maltodextrin in people with Oxidative Stress and Muscle Fatigue, run by Federal University of Health Science of Porto Alegre 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 3 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: finished, as of the sponsor's last update on 26 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress In Blood Collection (time frame: 15 days). 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 26 Jan 2018.