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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250556
Other study ID # creatineforwomen
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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