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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05525871
Other study ID # UCAMCFE-00027
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date January 20, 2023

Study information

Verified date July 2022
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, single-center, parallel, team-stratified, stratified experimental study to evaluate the efficacy of a high sports supplement in improving high-intensity intermittent exercise performance in professional female soccer players.


Description:

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned). The product to be consumed will be Nitrates and Citrulline Malate. Participants will consume the product for 30 days. The intake should be done two hours before each training session and the same dose will be consumed. The women's soccer players will perform a stress test with gas analysis to measure performance, as well as a Wingate test without consumption of the products. Five days later, the players will perform the Yo-Yo IR1 test in the field and will repeat the same tests performed at the beginning of the test after product consumption.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 20, 2023
Est. primary completion date September 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Present at the time of signing the informed consent at the age between 18 and 40 years. - Female. - Healthy subjects without any chronic disease. - Volunteers capable of understanding the clinical study, willing to give their written informed. consent and comply with the procedures and requirements of the study. and requirements of the study. Exclusion Criteria: - Players who change teams during the experimental study. - Smoking subjects. - Subjects using mouthwashes during the study. - Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study. factors that limit their ability to cooperate during the study. - Subjects whose status makes them ineligible for the study, at the discretion of the investigator discretion of the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nitrates and Citrulline Malate
Female soccer players should consume the experimental product for 30 days to evaluate the efficacy of a sports supplement high in nitrates combined with citrulline malate in the improvement of performance in high-intensity intermittent exercise. high intensity
Control product
Fruit puree

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 Aerobic and anaerobic thresholds - VO2max Measured with a gas analyzer Change in initial maximal oxygen consumption at 30 days
Primary Fatigue in jumping Measured with a contact platform Change in initial jump fatigue at 30 days
Primary Anaerobic capacity Measured with a Monark cycloergometer Change in baseline anaerobic capacity at 30 days
Secondary Microcapillary blood This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood. It will be measured on two different occasions. Day one and 30 days later.
Secondary Lactate Lactate levels will be measured using the Lactate Pro It will be measured on two different occasions. One on the first day (without intake of product ) and 30 days later, the same measurements but after having consumed the product
Secondary Safety variables It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. It will be measured on two different occasions. Day one and 30 days later.
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