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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Supplementation

Intervention / Treatment
-----------------
* Dietary Supplement: Nitrates and Citrulline Malate
* Dietary Supplement: Control product


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrates and Citrulline Malate<br>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<br>* 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<br>|
| Placebo Comparator: Control product<br>Consumption of placebo product (Fruit puree) | Dietary Supplement: Control product<br>* Fruit puree<br>|

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nitrates, Citrulline malate, Soccer