NCT06180512

Brief Summary

Randomized, controlled, double-blind, single-center, double-blind clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of a sustained release beta alanine on physiological physical performance efficacy in recreational cyclists.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed
Last Updated

February 16, 2024

Status Verified

November 1, 2023

Enrollment Period

18 days

First QC Date

December 2, 2023

Last Update Submit

February 15, 2024

Conditions

Beta Alanine Supplementation

Keywords

Acute effectBeta Alanine

Outcome Measures

Primary Outcomes (2)

  • Power

    Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).

    It will be measured on two different occasions. Day one and seven days later with acute consumption of product.

  • Distance covered

    Physical performance is measured by direct variables evaluated by the power roller.

    It will be measured on two different occasions. Day one and seven days later with acute consumption of product.

Secondary Outcomes (5)

  • Fatigue

    Change of baseline rate of perceived exertion at seven days

  • Paresthesia test

    It will be measured on two different occasions. on day 1 (before consumption) and seven days after (after consumption).

  • Microcapillary blood

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

  • Lactate

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

  • Heart Rate

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

Study Arms (3)

Beta Alanine high dose

EXPERIMENTAL

Consumption for 1 day.

Dietary Supplement: Beta Alanine high dose

Beta Alanine low dose

EXPERIMENTAL

Consumption for 1 day.

Dietary Supplement: Beta Alanine low dose

Control group

PLACEBO COMPARATOR

Consumption for 1 day.

Dietary Supplement: Control group

Interventions

Beta Alanine high doseDIETARY_SUPPLEMENT

4 intakes of 5 g of beta alanine every 1 hour and 15 minutes.

Beta Alanine high dose
Beta Alanine low doseDIETARY_SUPPLEMENT

4 intakes of 2.5 g of beta alanine every 1 hour and 15 minutes.

Beta Alanine low dose
Control groupDIETARY_SUPPLEMENT

4 intakes of 2.5 g of wheat semolina every 1 hour and 15 minutes.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male cyclists with more than two years of cycling experience.
  • Perform tests without fatigue.
  • Road bike training at least twice a week.

You may not qualify if:

  • Participants with chronic illness.
  • Have a long-term injury that prevents you from training in the previous month.
  • Inability to understand informed consent.
  • Have consumed beta alanine in the three years prior to the start of the study.
  • Consumption of other supplements that may alter performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

beta-AlanineControl Groups

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and ProteinsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 22, 2023

Study Start

December 4, 2023

Primary Completion

December 22, 2023

Study Completion

January 22, 2024

Last Updated

February 16, 2024

Record last verified: 2023-11

Locations

ES(1)