Creatine Supplementation for Female Football

Athletes Clinical Trial

Official title:

Creatine Supplementation in Young and Elite Female Football Players

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250556
• Other study ID #: creatineforwomen
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female football players

Exclusion Criteria:

• age under 18

Related Conditions & MeSH terms

• Athletes

Intervention

Dietary Supplement:
• creatine
creatine supplementation (Creapure)

Locations

Country	Name	City	State
Brazil	School of Medicine, University of Sao Paulo	Sao Paulo
Brazil	School of Medicine of the University of Sao Paulo	São Paulo	Sao Paulo / SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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