NCT05525871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

November 27, 2023

Status Verified

July 1, 2022

Enrollment Period

26 days

First QC Date

August 9, 2022

Last Update Submit

November 23, 2023

Conditions

Supplementation

Keywords

NitratesCitrulline malateSoccer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Microcapillary blood

    It will be measured on two different occasions. Day one and 30 days later.

  • Lactate

    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 will be measured on two different occasions. Day one and 30 days later.

Study Arms (2)

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.

Dietary Supplement: Nitrates and Citrulline Malate

Control product

PLACEBO COMPARATOR

Consumption of placebo product (Fruit puree)

Dietary Supplement: Control product

Interventions

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

Nitrates and Citrulline Malate
Control productDIETARY_SUPPLEMENT

Fruit puree

Control product

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Nitratescitrulline malateControl Groups

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic ChemicalsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2022

First Posted

September 2, 2022

Study Start

August 15, 2022

Primary Completion

September 10, 2022

Study Completion

January 20, 2023

Last Updated

November 27, 2023

Record last verified: 2022-07

Locations

ES(1)