FatigueNCT03203785
Effect of Carbohydrate Consumption on Fatigue and Muscle Damage in Jiu-Jitsu Athletes
A study testing Carbohydrate (maltodextrin) in people with Fatigue and Exercise-induced Muscle Damage, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 14 Jiu-Jitsu athletes between 18 and 33 years. The aim of the study is to evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle damage in Jiu-Jitsu athletes. Read more about this study
- Who is it for?
- Ages 18 to 33 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Exercise-induced Muscle Damage
- What is being tested?
- Carbohydrate (maltodextrin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jun 2017to 31 Dec 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 18 to 33 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Compete in the categories of weight between 70kg and 88,3kg (weight classification from light to medium heavy, belonging to the bands purple to brown).
- Age between 18 and 33 years.
- Be training at least three times a week, minimum of 1,5 hours per day, for at least 3 consecutive months.
- Have not used anabolic steroids in the last 6 months during the study period.
- Do not use any type of dietary supplement in the last 3 months.
- Self-declared healthy individuals.
Who cannot join
- Recent muscle injury (within the last 3 months) that compromises and / or impedes the performance of the exercise requested in the study.
- Be in a time of rapid weight loss (pre-competition).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Carbohydrate Consumption on Fatigue and Muscle Damage in Jiu-Jitsu Athletes: A Randomized Clinical Trial
The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 14 Jiu-Jitsu athletes between 18 and 33 years. The aim of the study is to evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle damage in Jiu-Jitsu athletes.
Read the detailed description
Brazilian Jiu-Jitsu (BJJ) is a sport characterized by intermittent high-intensity efforts separated by periods of low intensity. Muscular strength is considered one of the most important physical components to be developed, especially in the upper limbs through dynamic and static actions. The activities of high intensity (relation effort-pause) carried out by the upper and lower limbs during BJJ can induce muscle fatigue. In order to minimize the glycogen depletion and to guarantee the availability of energy substrate to the athlete during the physical exercise, the carbohydrate intake before moderate intensity exercises should be between 5-7 g / kg of weight / day. The intervention group will receive a 30g maltodextrin beverage and the placebo group a non-carbohydrate drink. There will be 3 combat simulations of 8 min each, with intervals of 10 min between fights. Athletes will be instructed to remain with their usual intake during the study. The outcomes will be: manual grip strength (dynamometer), upper limb strength (KGST), lower limb strength (vertical jump), subjective exertion perception (Borg scale), pain perception (Nilsson scale), blood markers of muscle damage (CK and LDH), lactate, and glycemia.
- Conditions
- Fatigue, Exercise-induced Muscle Damage
- Being tested
- Carbohydrate (maltodextrin), Placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate (maltodextrin)Dietary supplement
maltodextrin flavored
PlaceboOther
non-caloric drink
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate | Experimental | 30g of carbohydrate (maltodextrin) diluted in 300ml of water. Athletes will drink 100ml before and 100ml in the first and second interval between exercise. Receives: Dietary Supplement: Carbohydrate (maltodextrin) |
| Placebo | Placebo comparator | 300 ml of a non-caloric drink. Athletes will drink 100ml before and 100ml in the first and second interval between exercise. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in upper limbs strength
Kimono Grip Strength Test
Measured: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise
Secondary outcomes (6)
change in lower limbs power
Horizontal Countermovement Jump
Measured: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise
change in hand grip strength
Grip Strength Test
Measured: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise
change in creatine kinase
3 ml of blood samples
Measured: Pre-exercise; immediatly post-exercise; 24hour and 48hour after exercise
change in glucose
fingertip blood measured by Accutrend® Active glucose-specific reagent tape
Measured: Pre-exercise; at 2 intervals during exercise; immediatly post-exercise
change in lactate
fingertip blood measured by Accutrend Plus.
Measured: At 2 intervals during exercise; immediatly post-exercise
change in lactate dehydrogenase
3 ml of blood samples
Measured: Pre-exercise; immediatly post-exercise; 24hour and 48hour after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start26 Jun 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 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, Cláudia Dornelles Schneider, Federal University of Health Science of Porto Alegre
- Investigators
- Claudia D Schneider, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203785
- Sponsor's protocol ID
- 1.873.861
- Status last verified
- Jan 2019
- First submitted
- 26 Jun 2017
- Last updated
- 16 Jan 2019
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carbohydrate Consumption on Fatigue and Muscle Damage in Jiu-Jitsu Athletes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03203785
- Acronym / sponsor ID
- 1.873.861
- Conditions
- Fatigue, Exercise-induced Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 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.
The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 14 Jiu-Jitsu athletes between 18 and 33 years. The aim of the study is to evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle damage in Jiu-Jitsu athletes.
Detailed description
Brazilian Jiu-Jitsu (BJJ) is a sport characterized by intermittent high-intensity efforts separated by periods of low intensity. Muscular strength is considered one of the most important physical components to be developed, especially in the upper limbs through dynamic and static actions. The activities of high intensity (relation effort-pause) carried out by the upper and lower limbs during BJJ can induce muscle fatigue. In order to minimize the glycogen depletion and to guarantee the availability of energy substrate to the athlete during the physical exercise, the carbohydrate intake before moderate intensity exercises should be between 5-7 g / kg of weight / day. The intervention group will receive a 30g maltodextrin beverage and the placebo group a non-carbohydrate drink. There will be 3 combat simulations of 8 min each, with intervals of 10 min between fights. Athletes will be instructed to remain with their usual intake during the study. The outcomes will be: manual grip strength (dynamometer), upper limb strength (KGST), lower limb strength (vertical jump), subjective exertion perception (Borg scale), pain perception (Nilsson scale), blood markers of muscle damage (CK and LDH), lactate, and glycemia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate | Experimental | Dietary Supplement: Carbohydrate (maltodextrin)30g of carbohydrate (maltodextrin) diluted in 300ml of water. Athletes will drink 100ml before and 100ml in the first and second interval between exercise. |
| Placebo | Placebo comparator | Other: Placebo300 ml of a non-caloric drink. Athletes will drink 100ml before and 100ml in the first and second interval between exercise. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Compete in the categories of weight between 70kg and 88,3kg (weight classification from light to medium heavy, belonging to the bands purple to brown).
- Age between 18 and 33 years.
- Be training at least three times a week, minimum of 1,5 hours per day, for at least 3 consecutive months.
- Have not used anabolic steroids in the last 6 months during the study period.
- Do not use any type of dietary supplement in the last 3 months.
Key exclusion criteria (2 listed)
- Recent muscle injury (within the last 3 months) that compromises and / or impedes the performance of the exercise requested in the study.
- Be in a time of rapid weight loss (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 |
|---|---|---|
| Carbohydrate (maltodextrin)maltodextrin flavored | Dietary supplement | Carbohydrate |
| Placebonon-caloric drink | Other | Placebo |
Primary outcome
change in upper limbs strength
Time frame: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise
Kimono Grip Strength Test
6 secondary outcomes
change in lower limbs power
Time frame: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise
change in hand grip strength
Time frame: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise
change in creatine kinase
Time frame: Pre-exercise; immediatly post-exercise; 24hour and 48hour after exercise
change in glucose
Time frame: Pre-exercise; at 2 intervals during exercise; immediatly post-exercise
change in lactate
Time frame: At 2 intervals during exercise; immediatly post-exercise
change in lactate dehydrogenase
Time frame: Pre-exercise; immediatly post-exercise; 24hour and 48hour after exercise
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 16 Jan 2019.
- 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.
Claudia D Schneider, PhD 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 Carbohydrate (maltodextrin) in people with Fatigue and Exercise-induced Muscle Damage, 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 6 inclusion and 2 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 16 Jan 2019. 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?
change in upper limbs strength (time frame: Pre-exercise; at 2 intervals during exercise; 24hour and 48hour after exercise). 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 16 Jan 2019.