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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04427319
Other study ID # UCAMCFE-00014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2020
Est. completion date June 12, 2020

Study information

Verified date June 2020
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 12, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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:

- Adverse event

- Protocol violation

- Lost to follow-up

- Allergy to any of the components of the treatment or placebo product. This includes allergy to ß-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ß-alanine
7 days of consumption
wheat semolina
7 days of consumption

Locations

Country Name City State
Spain Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Rate of perceived exertion Change of baseline rate of perceived exertion at seven days
Secondary Performance outcomes Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence. It will be measured on two different occasions. Day one and seven days later.
Secondary Paresthesia test Visual analogue scale (1-10) It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.
Secondary Microcapillary blood This test provides biochemical variables (ABL90FLEX). It will be measured on two different occasions. Day one and seven days later.
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