Creatine Supplementation for Female Football

NCT06250556 | Unknown

• 1 other identifier: creatineforwomen
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Athletes

Outcome Measures

Primary Outcomes (1)

• kidney function

  serum creatinine levels

  baseline and after the sport season (~12 months)

Secondary Outcomes (9)

• kidney function

  baseline and after the sport season (~12 months)

• kidney function

  baseline and after the sport season (~12 months)

• kidney function

  baseline and after the sport season (~12 months)

• kidney function

  baseline and after the sport season (~12 months)

• muscle damage

  baseline and after the sport season (~12 months)

Study Arms (1)

creatine supplementation

EXPERIMENTAL

Dietary Supplement: creatine

Interventions

creatine DIETARY_SUPPLEMENT

creatine supplementation (Creapure)

creatine supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female football players

You may not qualify if:

• age under 18

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

School of Medicine of the University of Sao Paulo

São Paulo, Sao Paulo / SP, Brazil

RECRUITING

School of Medicine, University of Sao Paulo

São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: pre-to-post design for experiment 2.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 9, 2024
• Study Start: February 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

BR (2)