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CompletedNCT04427319ELITEUpdated Jul 30, 2020

The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists

An interventional study of β-alanine and wheat semolina in Supplementation and Cyclists, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2020, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).

Read the detailed description

After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).

A simple randomisation will be performed using software by a random number generator, and assigned to participants.

02

Conditions studied

  • Supplementation
  • Cyclists
03

In context

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Not respecting rest the day before physical tests.
  • Not being in a fasted state (at least 2 h from last meal).
  • Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial.
  • Not being available to perform every trial on the same conditions at the same time of the day.
  • Not sticking to the same diet, 24 h before each trial.

Exclusion criteria

Exclusion Criteria:

  • Adverse event
  • Protocol violation
  • Lost to follow-up
  • Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Experimental group

    Product: β-Alanine Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study.

    Dietary Supplement: β-alanine

  • Placebo comparator
    Placebo group

    Product: wheat semolina Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study.

    Dietary Supplement: wheat semolina

Interventions

  • Dietary supplementβ-alanine

    7 days of consumption

  • Dietary supplementwheat semolina

    7 days of consumption

06

What researchers measure

Primary outcomes

  1. Fatigue

    Rate of perceived exertion

    Time frame: Change of baseline rate of perceived exertion at seven days

Secondary outcomes

  1. Performance outcomes

    Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence.

    Time frame: It will be measured on two different occasions. Day one and seven days later.

  2. Paresthesia test

    Visual analogue scale (1-10)

    Time frame: It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.

  3. Microcapillary blood

    This test provides biochemical variables (ABL90FLEX).

    Time frame: It will be measured on two different occasions. Day one and seven days later.

07

Study locations

1 site
  • Catholic University of Murcia
    Murcia, 30107, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04427319
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Francisco Javier López Román (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Jun 11, 2020
Start date
Feb 10, 2020
Primary completion
Mar 6, 2020
Completion
Jun 12, 2020
Last update
Jul 30, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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