Study to Analyze the Efficacy of Acute Intake With a β-alanine Supplement in Recreational Cyclists (B-AC1)

Randomized Clinical Trial to Analyze the Efficacy of Acute Intake of Different Doses of a β-alanine Supplement on Performance in Recreational Cross-country Road Cyclists

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.

Study Overview

• Status: Completed
• Conditions: Beta Alanine Supplementation
• Intervention / Treatment: Dietary supplement: Beta Alanine high dose; Dietary supplement: Beta Alanine low dose; Dietary supplement: Control group

Detailed Description

Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is beta alanine. Participants will consume the product for 1 day. They will have to take four intakes every hour and a quarter, on the same day.

The study subjects will have to make 2 visits to the laboratory. In the first one, they will have to perform a 10-minute time trial, without consumption. In the second visit, they will perform the same performance test but with acute consumption of the product. Their physical and physiological performance will be evaluated.

The two tests will be separated by 7 days.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta Alanine high dose; Consumption for 1 day.	Dietary supplement: Beta Alanine high dose; 4 intakes of 5 g of beta alanine every 1 hour and 15 minutes.
Experimental: Beta Alanine low dose; Consumption for 1 day.	Dietary supplement: Beta Alanine low dose; 4 intakes of 2.5 g of beta alanine every 1 hour and 15 minutes.
Placebo Comparator: Control group; Consumption for 1 day.	Dietary supplement: Control group; 4 intakes of 2.5 g of wheat semolina every 1 hour and 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Rate of perceived exertion, assessed by the 10-point modified Borg Scale.	Change of baseline rate of perceived exertion at seven days
Paresthesia test	Visual analogue scale (1-10)	It will be measured on two different occasions. on day 1 (before consumption) and seven days after (after consumption).
Microcapillary blood	This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood (Na, K, Glucose, Lactate, etc). It is used to evaluate the effort made by the cyclist.	It will be measured on two different occasions. Day one and seven days later.
Lactate	Lactate levels will be measured using the Lactate Pro	It will be measured on two different occasions. Day one and seven days later.
Heart Rate	The heart rate will be evaluated by means of a heart rate strap.	It will be measured on two different occasions. Day one and seven days later.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Acute effect; Beta Alanine
• Other Study ID Numbers: UCAMCFE-00029

Drug and device information, study documents

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