Creatine Supplementation for Female Football

Creatine Supplementation in Young and Elite Female Football Players

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.

Study Overview

• Status: Recruiting
• Conditions: Athletes
• Intervention / Treatment: Dietary supplement: creatine

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Recruiting
    • School of Medicine, University of Sao Paulo
    • Contact: Bruno Gualano, PhD; Phone Number: 551126618022; Email: gualano@usp.br
  • Sao Paulo / SP
    • São Paulo, Sao Paulo / SP, Brazil
      • Recruiting
      • School of Medicine of the University of Sao Paulo
      • Contact: Tiemi Saito; Phone Number: 551130618789; Email: tiemisaito01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• female football players

Exclusion Criteria:

• age under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: creatine supplementation	Dietary supplement: creatine; creatine supplementation (Creapure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kidney function	serum creatinine levels	baseline and after the sport season (~12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kidney function	urinary creatinine levels	baseline and after the sport season (~12 months)
kidney function	serum urea levels	baseline and after the sport season (~12 months)
kidney function	serum sodium levels	baseline and after the sport season (~12 months)
kidney function	serum potassium levels	baseline and after the sport season (~12 months)
muscle damage	serum creatine kinase levels	baseline and after the sport season (~12 months)
hemogram	platelet count	baseline and after the sport season (~12 months)
hemogram	red blood cell count	baseline and after the sport season (~12 months)
hemogram	white blood cell count	baseline and after the sport season (~12 months)
hemogram	erythrocyte sedimentation rate	baseline and after the sport season (~12 months)

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: creatineforwomen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No