Athletic ProteinuriaNCT03155919
Taurine Supplementation and Triathletes
A study testing TAUchoc and PLAchoc in people with Athletic Proteinuria, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central nervous system, especially in muscles. It has several beneficial physiological effects like antioxidant action, and could increase muscle force contraction and insulin sensibility. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Proteinuria
- What is being tested?
- TAUchoc and PLAchoc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Aug 2014
- 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 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male, long distance triathletes, who competed in semiprofessional triathlons. Their training was focused on the Brazilian Ironman Championships.
Who cannot join
- Participants were excluded if they had experienced muscle injury in the past six months and/or were currently taking chronic or daily doses of anti-inflammatory medication or nutritional supplements.
- Participants who had a history of cardiovascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Taurine and Chocolate Milk Supplementation in Body Composition, Athletic Performance and Oxidative Stress in Triathletes.
Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central nervous system, especially in muscles. It has several beneficial physiological effects like antioxidant action, and could increase muscle force contraction and insulin sensibility. Triathlon is a sport of medium to high intensity, that can causes an increase in the rate of oxygen consumption during intense exercise and consequently increases free radicals production and oxidative stress, which may compromise an athlete's performance. Due to the weekly intense training, triathletes need nutritional care ranging from calories and nutrients adequacy to the use of specific nutrients that can help to maintain health. Thus, it is believed that the use of taurine associated with chocolate milk after exercise can promote general metabolic insulin action in order to favor carbohydrates metabolism regulation, assist muscle recover and prevent oxidative damage and thus promote triathletes performance and muscle mass gain. Thus, the aim of this project is to evaluate the effects of taurine and chocolate milk supplementation in body composition, athletic performance and oxidative stress in triathletes.
Read the detailed description
BACKGROUND: Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central nervous system, especially in muscles. It has several beneficial physiological effects like antioxidant action, and could increase muscle force contraction and insulin sensibility. Triathlon is a sport of medium to high intensity, that can causes an increase in the rate of oxygen consumption during intense exercise and consequently increases free radicals production and oxidative stress, which may compromise an athlete's performance. Due to the weekly intense training, triathletes need nutritional care ranging from calories and nutrients adequacy to the use of specific nutrients that can help to maintain health. Thus, it is believed that the use of taurine associated with chocolate milk after exercise can promote general metabolic insulin action in order to favor carbohydrates metabolism regulation, assist muscle recover and prevent oxidative damage and thus promote triathletes performance and muscle mass gain.
OBJECTIVE: Evaluate the effects of taurine and chocolate milk supplementation in body composition, athletic performance and oxidative stress in triathletes MÉTHODS: A double-blind, crossover, 2-week washout study will be conducted with 20 male triathletes, aged 30 to 45 years, which will be offered during eight weeks capsules containing three grams of taurine or placebo and 400 ml of chocolate milk ready to drink. In order to assess the effects of supplementation, concentrations of serum and urinary taurine, lactate, insulin, insulin sensitivity (HOMA-IR), markers of protein metabolism (urinary nitrogen, creatinine and urea) and oxidative stress markers (MDA, GSH and vitamin E) will be quantified. Body composition will be measured by the method of deuterium labeled water. The evaluations will occur in four stages: 1o - before starting the training season; 2o - after 8 weeks of training; 3o- before starting the second training season; and 4o- after 8 weeks of training and supplementation completion. Data will be organized according to the study groups on average and standard deviation with application of analysis of variance test for verifying significant differences
- Conditions
- Athletic Proteinuria
- Being tested
- TAUchoc, PLAchoc
- Keywords
- taurine, triathletes, oxidative stress, chocolate milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAUchocDietary supplement
The supplements were offered during eight weeks in capsules containing three grams of taurine powder and 400 ml of chocolate milk ready to drink.
PLAchocDietary supplement
The supplements were offered during eight weeks in capsules containing three grams of placebo (starch powder) and 400 ml of chocolate milk ready to drink.
| Study group | Role | What they receive |
|---|---|---|
| TAUchoc | Experimental | Treatment composed by taurine powder and chocolate milk Receives: Dietary Supplement: TAUchoc |
| PLAchoc | Placebo comparator | Treatment composed by placebo (starch powder) and chocolate milk Receives: Dietary Supplement: PLAchoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline taurine plasma levels at 8 weeks
Plasma taurine was determined by high-performance liquid chromatography (Shimadzu, model LC 10AD). Taurine 99 % was used as standard (Sigma-Aldrich, St. Louis, MO, USA) following the method of Deyl et al (1986).
Measured: 8 weeks
Secondary outcomes (3)
Evaluation of the effects of taurine and chocolate milk supplementation on protein metabolism markers of triathletes.
Determination of blood creatinine and urea by Labtest Kit, and quantification of urinary excretion of nitrogen according to the method proposed by Grimble et al. (1988).
Measured: Pre and Post the 8 weeks of treatment
Evaluation of the effects of taurine and chocolate milk supplementation on triathletes aerobic performance
All subjects performed a maximal incremental running test with 1% gradient on a treadmill (Super ATL, Inbramed, Brazil) in a controlled environment. The test began at 8 km·h-1 and speed was increased by 1 km·h-1 every three minutes until volitional exhaustion.
Measured: Pre and Post the 8 weeks of treatment
Evaluation of the effects of taurine and chocolate milk supplementation on oxidative stress of triathletes.
Oxidative stress markers indicative of lipid peroxidation determined: reduced glutathione (GSH) according to the method of Sedlak and Lindsay (1968) and malondialdehyde (MDA) using the method proposed by Gerard-Monnier et al. (Gerard-Monnier et al. 1998).
Measured: Pre and Post the 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startFeb 2014
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic ProteinuriaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind, crossover, 2-week washout study will be conducted with 20 male triathletes, aged 30 to 45 years, which will be offered during eight weeks capsules containing three grams of taurine or placebo and 400 ml of chocolate milk ready to drink.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155919
- Sponsor's protocol ID
- AN FCFAR UNESP
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD won´t be available
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taurine and Chocolate Milk Supplementation in Body Composition, Athletic Performance and Oxidative Stress in Triathletes.
- ClinicalTrials.gov ID
- NCT03155919
- Acronym / sponsor ID
- AN FCFAR UNESP
- Conditions
- Athletic Proteinuria
- Keywords
- taurine, triathletes, oxidative stress, chocolate milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 May 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.
Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central nervous system, especially in muscles. It has several beneficial physiological effects like antioxidant action, and could increase muscle force contraction and insulin sensibility. Triathlon is a sport of medium to high intensity, that can causes an increase in the rate of oxygen consumption during intense exercise and consequently increases free radicals production and oxidative stress, which may compromise an athlete's performance. Due to the weekly intense training, triathletes need nutritional care ranging from calories and nutrients adequacy to the use of specific nutrients that can help to maintain health. Thus, it is believed that the use of taurine associated with chocolate milk after exercise can promote general metabolic insulin action in order to favor carbohydrates metabolism regulation, assist muscle recover and prevent oxidative damage and thus promote triathletes performance and muscle mass gain. Thus, the aim of this project is to evaluate the effects of taurine and chocolate milk supplementation in body composition, athletic performance and oxidative stress in triathletes.
Detailed description
BACKGROUND: Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central nervous system, especially in muscles. It has several beneficial physiological effects like antioxidant action, and could increase muscle force contraction and insulin sensibility. Triathlon is a sport of medium to high intensity, that can causes an increase in the rate of oxygen consumption during intense exercise and consequently increases free radicals production and oxidative stress, which may compromise an athlete's performance. Due to the weekly intense training, triathletes need nutritional care ranging from calories and nutrients adequacy to the use of specific nutrients that can help to maintain health. Thus, it is believed that the use of taurine associated with chocolate milk after exercise can promote general metabolic insulin action in order to favor carbohydrates metabolism regulation, assist muscle recover and prevent oxidative damage and thus promote triathletes performance and muscle mass gain.
OBJECTIVE: Evaluate the effects of taurine and chocolate milk supplementation in body composition, athletic performance and oxidative stress in triathletes MÉTHODS: A double-blind, crossover, 2-week washout study will be conducted with 20 male triathletes, aged 30 to 45 years, which will be offered during eight weeks capsules containing three grams of taurine or placebo and 400 ml of chocolate milk ready to drink. In order to assess the effects of supplementation, concentrations of serum and urinary taurine, lactate, insulin, insulin sensitivity (HOMA-IR), markers of protein metabolism (urinary nitrogen, creatinine and urea) and oxidative stress markers (MDA, GSH and vitamin E) will be quantified. Body composition will be measured by the method of deuterium labeled water. The evaluations will occur in four stages: 1o - before starting the training season; 2o - after 8 weeks of training; 3o- before starting the second training season; and 4o- after 8 weeks of training and supplementation completion. Data will be organized according to the study groups on average and standard deviation with application of analysis of variance test for verifying significant differences
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double-blind, crossover, 2-week washout study will be conducted with 20 male triathletes, aged 30 to 45 years, which will be offered during eight weeks capsules containing three grams of taurine or placebo and 400 ml of chocolate milk ready to drink.
| Arm | Type | Receives |
|---|---|---|
| TAUchoc | Experimental | Dietary Supplement: TAUchocTreatment composed by taurine powder and chocolate milk |
| PLAchoc | Placebo comparator | Dietary Supplement: PLAchocTreatment composed by placebo (starch powder) and chocolate milk |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male, long distance triathletes, who competed in semiprofessional triathlons. Their training was focused on the Brazilian Ironman Championships.
Key exclusion criteria (2 listed)
- Participants were excluded if they had experienced muscle injury in the past six months and/or were currently taking chronic or daily doses of anti-inflammatory medication or nutritional supplements.
- Participants who had a history of cardiovascular diseases.
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 |
|---|---|---|
| TAUchocThe supplements were offered during eight weeks in capsules containing three grams of taurine powder and 400 ml of chocolate milk ready to drink. | Dietary supplement | TAUchoc |
| PLAchocThe supplements were offered during eight weeks in capsules containing three grams of placebo (starch powder) and 400 ml of chocolate milk ready to drink. | Dietary supplement | PLAchoc |
Primary outcome
Change from Baseline taurine plasma levels at 8 weeks
Time frame: 8 weeks
Plasma taurine was determined by high-performance liquid chromatography (Shimadzu, model LC 10AD). Taurine 99 % was used as standard (Sigma-Aldrich, St. Louis, MO, USA) following the method of Deyl et al (1986).
3 secondary outcomes
Evaluation of the effects of taurine and chocolate milk supplementation on protein metabolism markers of triathletes.
Time frame: Pre and Post the 8 weeks of treatment
Evaluation of the effects of taurine and chocolate milk supplementation on triathletes aerobic performance
Time frame: Pre and Post the 8 weeks of treatment
Evaluation of the effects of taurine and chocolate milk supplementation on oxidative stress of triathletes.
Time frame: Pre and Post the 8 weeks of treatment
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 May 2017.
- Individual participant dataSharing planned: No. IPD won´t be available
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAUchoc and PLAchoc in people with Athletic Proteinuria, run by University of Sao Paulo 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 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 May 2017. 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 from Baseline taurine plasma levels at 8 weeks (time frame: 8 weeks). 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 May 2017.