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24-Wk β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males

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ClinicalTrials.gov Identifier: NCT03655041
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.

Condition or disease Intervention/treatment Phase
Sports Nutritional Physiological Phenomena Dietary Supplement: Beta-alanine Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 24-Weeks of β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alanine

Arm Intervention/treatment
Experimental: Beta-Alanine
6.4 g/day of beta-alanine for 24 weeks
Dietary Supplement: Beta-alanine
Beta-alanine in sustained-release tablets to increase muscle carnosine content

Placebo Comparator: Placebo
6.4 g/day of maltodextrin for 24 weeks
Dietary Supplement: Placebo
Maltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine




Primary Outcome Measures :
  1. Muscle taurine content in mmol/kg [ Time Frame: Up to 24 weeks ]
    Change in the content of taurine in muscle will be determined using High-Pressure Liquid Chromatography of muscle biopsies


Secondary Outcome Measures :
  1. Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L [ Time Frame: Up to 24 weeks ]
    Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase will be analysed from venous blood samples

  2. Albumin; globulin; creatinine in mg/dL [ Time Frame: Up to 24 weeks ]
    Albumin; globulin; creatinine will be analysed from venous blood samples



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Smokers
  • Chronic disease
  • Prior or current use of steroids
  • Use of creatine in the last 6 months
  • Use of beta-alanine in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655041


Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Bruno Gualano, PhD University of Sao Paulo

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Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03655041     History of Changes
Other Study ID Numbers: 24WKBA
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bruno Gualano, University of Sao Paulo:
Physiological Phenomena