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

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

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.

Study Overview

• Status: Completed
• Conditions: Sports Nutritional Physiological Phenomena
• Intervention / Treatment: Dietary supplement: Beta-alanine; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle taurine content in mmol/kg	Change in the content of taurine in muscle will be determined using High-Pressure Liquid Chromatography of muscle biopsies	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L	Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase will be analysed from venous blood samples	Up to 24 weeks
Albumin; globulin; creatinine in mg/dL	Albumin; globulin; creatinine will be analysed from venous blood samples	Up to 24 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Bruno Gualano, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 15, 2015
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Physiological Phenomena
• Other Study ID Numbers: 24WKBA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No