Creatine Supplementation for Female Football

NCT ID: NCT06250556

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2024-12-30

Brief Summary

Creatine is an effective, inexpensive, and safe dietary supplement, which has been largely used in sports and clinical populations. However, creatine is much less studied in female athletes, with long-term data being particularly scant. This study aims to expand our knowledge on the effects of creatine supplementation in young (Under-20) and elite female football players. This study will comprise two experiments. The first one will be a randomized, controlled trial in which young athletes will be assigned into either creatine or placebo (n = 20). Before and 7 days after supplementation or placebo (4 x 5 g/d of Creapure or dextrose at same dose), athletes will perform a battery of performance tests. Blood and urinary biochemical parameters for assessing the safety of supplementation will be analyzed (creatinine, albuminuria, urea, sodium, potassium, liver enzymes, creatine kinase, hematology). Food intake will be assessed by means of 3-d 24-h dietary recalls. The second experiment will have a quasi-experimental design (i.e., pre-to-post), in which both young and elite football players (n = 70) will be supplemented with creatine (4 x 5 g/d for 7 days and then 5 days during the follow-up) and will be assessed for safety using the above-mentioned markers during the regular football season (~12 months). Assessments will be carried out at baseline, in the mid-season and after the season.

Conditions

Athletes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

creatine supplementation

Group Type: EXPERIMENTAL

creatine

Intervention Type: DIETARY_SUPPLEMENT

creatine supplementation (Creapure)

Interventions

creatine

creatine supplementation (Creapure)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• female football players

Exclusion Criteria

• age under 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Bruno Gualano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Medicine of the University of Sao Paulo

São Paulo, Sao Paulo / SP, Brazil

Site Status: RECRUITING

School of Medicine, University of Sao Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Tiemi Saito

Role: primary

tiemisaito01@gmail.com

551130618789

Bruno Gualano, PhD

Role: primary

gualano@usp.br

551126618022

Other Identifiers

creatineforwomen

Identifier Type: -

Identifier Source: org_study_id