Clinical trial NCT06250556: Creatine Supplementation for Female Football
Official title: Creatine Supplementation in Young and Elite Female Football Players
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Athletes
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-to-post design for experiment 2.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* female football players

Exclusion Criteria:

* age under 18

Primary outcomes:
measure: kidney function
timeFrame: baseline and after the sport season (~12 months)
Secondary outcomes:
measure: kidney function
timeFrame: baseline and after the sport season (~12 months)
measure: kidney function
timeFrame: baseline and after the sport season (~12 months)
measure: kidney function
timeFrame: baseline and after the sport season (~12 months)
measure: kidney function
timeFrame: baseline and after the sport season (~12 months)
measure: muscle damage
timeFrame: baseline and after the sport season (~12 months)
measure: hemogram
timeFrame: baseline and after the sport season (~12 months)
measure: hemogram
timeFrame: baseline and after the sport season (~12 months)
measure: hemogram
timeFrame: baseline and after the sport season (~12 months)
measure: hemogram
timeFrame: baseline and after the sport season (~12 months)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Medicine of the University of Sao Paulo
state: Sao Paulo / SP
city: Sao Paulo
country: Brazil
facility: School of Medicine, University of Sao Paulo
Study officials:
References: