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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03155919
Other study ID # AN FCFAR UNESP
Secondary ID
Status Completed
Phase N/A
First received May 12, 2017
Last updated May 15, 2017
Start date February 2014
Est. completion date August 2014

Study information

Verified date May 2017
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
TAUchoc
The supplements were offered during eight weeks in capsules containing three grams of taurine powder and 400 ml of chocolate milk ready to drink.
PLAchoc
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.

Locations

Country Name City State
Brazil Flavia Giolo de Carvalho Ribeirão Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 8 weeks
Secondary 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). Pre and Post the 8 weeks of treatment
Secondary 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. Pre and Post the 8 weeks of treatment
Secondary 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). Pre and Post the 8 weeks of treatment