Creatine Supplementation for Female Football

Not Applicable

Recruiting

• Conditions: Athletes
• Interventions: Dietary Supplement: creatine

• Registration Number: NCT06250556
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Study Start: 2024-02-10
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• female football players

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Exclusion Criteria

• age under 18

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
creatine supplementation	creatine	-

Primary Outcome Measures

Name	Time	Method
kidney function	baseline and after the sport season (~12 months)	serum creatinine levels

Secondary Outcome Measures

Name	Time	Method
kidney function	baseline and after the sport season (~12 months)	serum potassium levels
hemogram	baseline and after the sport season (~12 months)	erythrocyte sedimentation rate
muscle damage	baseline and after the sport season (~12 months)	serum creatine kinase levels

Trial Locations

Locations (2)

School of Medicine of the University of Sao Paulo; 🇧🇷 São Paulo, Sao Paulo / SP, Brazil

School of Medicine, University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil