Effects of Nitrates and Citrulline Malate on Performance in Professional Professional Soccer

Supplementation Clinical Trial

— NiCiFut  

Official title:

Experimental Study to Evaluate the Effects of Effects of a Sports Supplement Based on Nitrates and Citrulline Malate on Performance in Professional Soccer Players

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525871
• Other study ID #: UCAMCFE-00027
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Supplementation

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.