AthletesNCT06250556
Creatine Supplementation for Female Football
A study testing creatine in people with Athletes, run by University of Sao Paulo at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- creatine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesBrazil
- Study dates
- 10 Feb 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female football players
Who cannot join
- age under 18
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
School of Medicine of the University of Sao Paulo
São Paulo, Sao Paulo / SP
Tiemi Saito, 551130618789, tiemisaito01@gmail.com
- Recruiting
School of Medicine, University of Sao Paulo
São Paulo, 05403-000
Bruno Gualano, PhD, 551126618022, gualano@usp.br
About this study
Official title: Creatine Supplementation in Young and Elite Female Football Players
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
- Being tested
- creatine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatineDietary supplement
creatine supplementation (Creapure)
| Study group | Role | What they receive |
|---|---|---|
| creatine supplementation | Experimental | Not described Receives: Dietary Supplement: creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney function
serum creatinine levels
Measured: baseline and after the sport season (~12 months)
Secondary outcomes (9)
kidney function
urinary creatinine levels
Measured: baseline and after the sport season (~12 months)
kidney function
serum urea levels
Measured: baseline and after the sport season (~12 months)
kidney function
serum sodium levels
Measured: baseline and after the sport season (~12 months)
kidney function
serum potassium levels
Measured: baseline and after the sport season (~12 months)
muscle damage
serum creatine kinase levels
Measured: baseline and after the sport season (~12 months)
hemogram
platelet count
Measured: baseline and after the sport season (~12 months)
hemogram
red blood cell count
Measured: baseline and after the sport season (~12 months)
hemogram
white blood cell count
Measured: baseline and after the sport season (~12 months)
hemogram
erythrocyte sedimentation rate
Measured: baseline and after the sport season (~12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-to-post design for experiment 2.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250556
- Sponsor's protocol ID
- creatineforwomen
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation in Young and Elite Female Football Players
- ClinicalTrials.gov ID
- NCT06250556
- Acronym / sponsor ID
- creatineforwomen
- Conditions
- Athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-to-post design for experiment 2.
| Arm | Type | Receives |
|---|---|---|
| creatine supplementation | Experimental | Dietary Supplement: creatine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female football players
Key exclusion criteria (1 listed)
- age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creatinecreatine supplementation (Creapure) | Dietary supplement | creatine supplementation |
Primary outcome
kidney function
Time frame: baseline and after the sport season (~12 months)
serum creatinine levels
9 secondary outcomes
kidney function
Time frame: baseline and after the sport season (~12 months)
kidney function
Time frame: baseline and after the sport season (~12 months)
kidney function
Time frame: baseline and after the sport season (~12 months)
kidney function
Time frame: baseline and after the sport season (~12 months)
muscle damage
Time frame: baseline and after the sport season (~12 months)
hemogram
Time frame: baseline and after the sport season (~12 months)
hemogram
Time frame: baseline and after the sport season (~12 months)
hemogram
Time frame: baseline and after the sport season (~12 months)
hemogram
Time frame: baseline and after the sport season (~12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request.
Related trials for Athletes
Not yet recruitingObservational study
Isokinetic Knee Strength, Bilateral Muscle Balance, and Anaerobic Performance in Adolescent Athletes
Isokinetic Knee Strength, Hamstring-to-Quadriceps Strength Ratio
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Not yet recruiting
PLYOMETRIC TRAINING VERSUS CALISTHENIC TECHNIQUE FOR IMPROVING JUMP PERFORMANCE AND PATELLOFEMORAL FUNCTION IN KARATE ATHLETES
Jump Performance, Patellofemoral Joint
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
School of Medicine of the University of Sao Paulo
São Paulo, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine in people with Athletes, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kidney function (time frame: baseline and after the sport season (~12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.