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Taurine Supplementation and Triathletes

Primary Purpose

Athletic Proteinuria

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TAUchoc
PLAchoc
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Athletic Proteinuria focused on measuring taurine, triathletes, oxidative stress, chocolate milk

Eligibility Criteria

30 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Flavia Giolo de Carvalho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAUchoc

PLAchoc

Arm Description

Treatment composed by taurine powder and chocolate milk

Treatment composed by placebo (starch powder) and chocolate milk

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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).

Full Information

First Posted
May 12, 2017
Last Updated
May 15, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03155919
Brief Title
Taurine Supplementation and Triathletes
Official Title
Effects of Taurine and Chocolate Milk Supplementation in Body Composition, Athletic Performance and Oxidative Stress in Triathletes.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Proteinuria
Keywords
taurine, triathletes, oxidative stress, chocolate milk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
The taurine and placebo powder were offered in capsules identified by Taurine A and Taurine B.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAUchoc
Arm Type
Experimental
Arm Description
Treatment composed by taurine powder and chocolate milk
Arm Title
PLAchoc
Arm Type
Placebo Comparator
Arm Description
Treatment composed by placebo (starch powder) and chocolate milk
Intervention Type
Dietary Supplement
Intervention Name(s)
TAUchoc
Intervention Description
The supplements were offered during eight weeks in capsules containing three grams of taurine powder and 400 ml of chocolate milk ready to drink.
Intervention Type
Dietary Supplement
Intervention Name(s)
PLAchoc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline taurine plasma levels at 8 weeks
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the effects of taurine and chocolate milk supplementation on protein metabolism markers of triathletes.
Description
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).
Time Frame
Pre and Post the 8 weeks of treatment
Title
Evaluation of the effects of taurine and chocolate milk supplementation on triathletes aerobic performance
Description
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.
Time Frame
Pre and Post the 8 weeks of treatment
Title
Evaluation of the effects of taurine and chocolate milk supplementation on oxidative stress of triathletes.
Description
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).
Time Frame
Pre and Post the 8 weeks of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Flavia Giolo de Carvalho
City
Ribeirão Preto
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD won´t be available

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Taurine Supplementation and Triathletes

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