- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03155919
Taurine Supplementation and Triathletes
Effects of Taurine and Chocolate Milk Supplementation in Body Composition, Athletic Performance and Oxidative Stress in Triathletes.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo
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Ribeirão Preto, Sao Paulo, Brazil
- Flavia Giolo de Carvalho
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- male, long distance triathletes, who competed in semiprofessional triathlons. Their training was focused on the Brazilian Ironman Championships.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TAUchoc
Treatment composed by taurine powder and chocolate milk
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The supplements were offered during eight weeks in capsules containing three grams of taurine powder and 400 ml of chocolate milk ready to drink.
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PLACEBO_COMPARATOR: PLAchoc
Treatment composed by placebo (starch powder) and chocolate milk
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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).
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Pre and Post the 8 weeks of treatment
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Evaluation of the effects of taurine and chocolate milk supplementation on triathletes aerobic performance
Time Frame: Pre and Post the 8 weeks of treatment
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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.
|
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
|
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).
|
Pre and Post the 8 weeks of treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN FCFAR UNESP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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