SupplementationNiCiFutNCT05525871
Effects of Nitrates and Citrulline Malate on Performance in Professional Professional Soccer
A study testing Nitrates and Citrulline Malate in people with Supplementation, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Supplementation
- What is being tested?
- Nitrates and Citrulline Malate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Aug 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Supplementation
- Being tested
- Nitrates and Citrulline Malate, Control product
- Keywords
- Nitrates, Citrulline malate, Soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrates and Citrulline MalateDietary supplement
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 productDietary supplement
Fruit puree
| Study group | Role | What they receive |
|---|---|---|
| Nitrates and Citrulline Malate | Experimental | 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. Receives: Dietary Supplement: Nitrates and Citrulline Malate |
| Control product | Placebo comparator | Consumption of placebo product (Fruit puree) Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic and anaerobic thresholds - VO2max
Measured with a gas analyzer
Measured: Change in initial maximal oxygen consumption at 30 days
Fatigue in jumping
Measured with a contact platform
Measured: Change in initial jump fatigue at 30 days
Anaerobic capacity
Measured with a Monark cycloergometer
Measured: Change in baseline anaerobic capacity at 30 days
Secondary outcomes (3)
Microcapillary blood
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
Measured: It will be measured on two different occasions. Day one and 30 days later.
Lactate
Lactate levels will be measured using the Lactate Pro
Measured: 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.
Measured: It will be measured on two different occasions. Day one and 30 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start15 Aug 2022
- Primary completion10 Sep 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525871
- Sponsor's protocol ID
- UCAMCFE-00027
- Acronym
- NiCiFut
- Status last verified
- Jul 2022
- First submitted
- 9 Aug 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05525871
- Acronym / sponsor ID
- NiCiFut / UCAMCFE-00027
- Conditions
- Supplementation
- Keywords
- Nitrates, Citrulline malate, Soccer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrates and Citrulline Malate | Experimental | Dietary Supplement: Nitrates and Citrulline MalateGel 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. |
| Control product | Placebo comparator | Dietary Supplement: Control productConsumption of placebo product (Fruit puree) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrates and Citrulline MalateFemale 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 | Dietary supplement | Nitrates and Citrulline Malate |
| Control productFruit puree | Dietary supplement | Control product |
Primary outcome
Aerobic and anaerobic thresholds - VO2max
Time frame: Change in initial maximal oxygen consumption at 30 days
Measured with a gas analyzer
Fatigue in jumping
Time frame: Change in initial jump fatigue at 30 days
Measured with a contact platform
Anaerobic capacity
Time frame: Change in baseline anaerobic capacity at 30 days
Measured with a Monark cycloergometer
3 secondary outcomes
Microcapillary blood
Time frame: It will be measured on two different occasions. Day one and 30 days later.
Lactate
Time frame: 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
Time frame: It will be measured on two different occasions. Day one and 30 days later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrates and Citrulline Malate in people with Supplementation, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic and anaerobic thresholds - VO2max (time frame: Change in initial maximal oxygen consumption at 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.