- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404540
Effect of β-alanine Supplementation and Training on Ergogenic Measures and Plasma Metabolites in Untrained Young Adults
Effect of β-alanine Supplementation and Training on Ergogenic Parameters and Plasma Metabolites in Untrained Young Adults: a Randomized, Placebo-controlled, Double-blind Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, double-blind, placebo-controlled study was conducted to evaluate the effects of β-alanine supplementation combined with a structured exercise training program in untrained young adults. Participants were randomly assigned to receive either β-alanine supplementation or a matching placebo while completing a six-week supervised training intervention. Both participants and investigators responsible for training supervision and outcome assessments were blinded to group allocation.
The primary outcome measures focused on changes in physical performance capacity. Maximal muscle strength was assessed using standardized dynamometric measurements, and aerobic capacity was evaluated using a validated shuttle run test performed before and after the intervention.
Secondary outcome measures included changes in anthropometric parameters, pulmonary function, and exercise-related metabolic responses. Blood lactate concentrations were measured during standardized exercise testing to characterize metabolic responses to training and supplementation. In addition, fasting venous blood samples were collected before and after the intervention to determine plasma concentrations of β-alanine, histidine, and carnosine as biochemical outcome measures related to supplementation and training adaptation.
All outcome measures were collected at baseline and following completion of the six-week intervention period. Adverse events were monitored throughout the study duration through participant self-report and investigator observation. All study procedures were performed in accordance with ethical approval and institutional guidelines.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Pécs, Hungary
- University of Pecs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy young adults aged 18-30 years.
- Untrained individuals without participation in structured resistance or endurance training during the previous 6 months.
- Not physically inactive, but not engaged in regular structured exercise training.
- Ability to participate in a six-week supervised multicomponent exercise training program.
- Willingness to comply with study procedures, training sessions, and supplementation protocol.
- Provision of written informed consent.
Exclusion Criteria:
- Known cardiovascular, metabolic, neuromuscular, or musculoskeletal disease.
- Acute injury at the time of enrollment.
- Regular use of medications or dietary supplements affecting muscle metabolism or exercise performance.
- Participation in structured resistance or endurance training during the previous 6 months.
- Failure to comply with the study protocol or training requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: β-Alanine Supplementation
Participants received β-alanine supplementation at a dose of 50 mg/kg/day, divided into multiple daily doses, in combination with a supervised six-week exercise training program.
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β-alanine was administered orally at a dose of 50 mg/kg/day, divided into multiple daily doses and consumed with meals, throughout the six-week training intervention.
|
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Placebo Comparator: Placebo
Participants received a visually identical placebo following the same dosing schedule as the supplementation group, in combination with a supervised six-week exercise training program.
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Participants received visually identical placebo capsules following the same dosing schedule as the β-alanine group during the six-week training intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in maximal muscle strength
Time Frame: Baseline and 6 weeks
|
Maximal muscle strength was assessed by dynamometric measurements of maximal voluntary isometric contraction.
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Baseline and 6 weeks
|
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Change in aerobic capacity
Time Frame: Baseline and 6 weeks
|
Aerobic capacity was estimated by VO₂max derived from the 20-m multistage fitness test (shuttle run).
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index (BMI)
Time Frame: Baseline and 6 weeks
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Body mass index calculated from measured height and body mass..
|
Baseline and 6 weeks
|
|
Body fat percentage
Time Frame: Baseline and 6 weeks
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Body fat percentage estimated from standardized skinfold thickness measurements.
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Baseline and 6 weeks
|
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Forced vital capacity (FVC)
Time Frame: Baseline and 6 weeks
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Forced vital capacity measured by spirometry using a portable spirometer to assess respiratory function.
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Baseline and 6 weeks
|
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Acute blood lactate response to dynamometric exercise
Time Frame: Baseline and 6 weeks
|
Acute blood lactate responses were measured during standardized dynamometric exercise testing.
|
Baseline and 6 weeks
|
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Plasma β-alanine concentration
Time Frame: Baseline and 6 weeks
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Plasma β-alanine concentration measured from fasting venous blood samples.
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Baseline and 6 weeks
|
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Plasma histidine concentration
Time Frame: Baseline and 6 weeks
|
Plasma histidine concentration measured from fasting venous blood samples.
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Baseline and 6 weeks
|
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Plasma carnosine concentration
Time Frame: Baseline and 6 weeks
|
Plasma carnosine concentration measured from fasting venous blood samples.
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Baseline and 6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: Up to 6 weeks
|
Adverse events monitored through participant self-report and investigator observation.
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Up to 6 weeks
|
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
Other Study ID Numbers
- 316-2406-1/KK15/2011
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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