Effects of Nitrates and Citrulline Malate on Performance in Professional Professional Soccer (NiCiFut)

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

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.

Study Overview

• Status: Completed
• Conditions: Supplementation
• Intervention / Treatment: Dietary supplement: Nitrates and Citrulline Malate; Dietary supplement: Control product

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrates and Citrulline Malate; Gel elaborated from fruit puree with high polyphenol content, with the addition of nitrates and citrulline malate as study supplements. addition of nitrates and citrulline malate as study supplements.	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
Placebo Comparator: Control product; Consumption of placebo product (Fruit puree)	Dietary supplement: Control product; Fruit puree

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic and anaerobic thresholds - VO2max	Measured with a gas analyzer	Change in initial maximal oxygen consumption at 30 days
Fatigue in jumping	Measured with a contact platform	Change in initial jump fatigue at 30 days
Anaerobic capacity	Measured with a Monark cycloergometer	Change in baseline anaerobic capacity at 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): September 10, 2022
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Nitrates; Citrulline malate; Soccer
• Other Study ID Numbers: UCAMCFE-00027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No