Oxygen DeficiencyCREGAA-OXYNCT06371651
Creatine and GAA for Brain Oxygenation
A study testing Supplement in people with Oxygen Deficiency, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Mar 2024to 12 Apr 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30 years
- Absence of metabolic disorders or other health complications
- Provision of signed informed consent
Who cannot join
- History of dietary supplement use within the preceding 4 weeks
- Lack of consent to randomization
- Concurrent participation in other studies
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: Enhancing Brain Oxygenation: Effects of Short-Term Co-Administration of Creatine and Guanidinoacetic Acid at Rest and During Stress
The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests.
- Conditions
- Oxygen Deficiency
- Being tested
- Supplement, Placebo
- Keywords
- creatine, guanidinoacetic acid, oxygen saturation, brain
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Dietary supplement containing creatine and guanidinoacetic acid
PlaceboDietary supplement
Inert substance
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | One sachet of supplement before breakfast and dinner Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | One sachet of inert compound before breakfast and dinner Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain oxygen saturation
Percentage of oxygen saturation in prefrontal brain
Measured: Change from baseline brain oxygen saturation at 2 weeks
Secondary outcomes (1)
Hemoglobin index
Concentration of hemoglobin index in prefrontal brain
Measured: Change from baseline hemoglobin index at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Mar 2024
- Primary completion10 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
- Investigators
- Sergej Ostojic, MD, PhD, Principal investigator, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371651
- Sponsor's protocol ID
- 23-1462-3
- Acronym
- CREGAA-OXY
- Status last verified
- May 2024
- First submitted
- 14 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in nutritional neuroscience. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Publications
Watanabe A, Kato N, Kato T. Effects of creatine on mental fatigue and cerebral hemoglobin oxygenation. Neurosci Res. 2002 Apr;42(4):279-85. doi: 10.1016/s0168-0102(02)00007-x.
PubMed 11985880Hammett ST, Wall MB, Edwards TC, Smith AT. Dietary supplementation of creatine monohydrate reduces the human fMRI BOLD signal. Neurosci Lett. 2010 Aug 2;479(3):201-5. doi: 10.1016/j.neulet.2010.05.054. Epub 2010 May 24.
PubMed 20570601Zanini D, Todorovic N, Ostojic SM. Creatine with guanidinoacetic acid improves prefrontal brain oxygenation before, during, and after a cognitive task: A randomized controlled pilot trial. Nutr Health. 2025 Jun;31(2):363-368. doi: 10.1177/02601060241300236. Epub 2024 Nov 21.
PubMed 39569437
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain Oxygenation: Effects of Short-Term Co-Administration of Creatine and Guanidinoacetic Acid at Rest and During Stress
- ClinicalTrials.gov ID
- NCT06371651
- Acronym / sponsor ID
- CREGAA-OXY / 23-1462-3
- Conditions
- Oxygen Deficiency
- Keywords
- creatine, guanidinoacetic acid, oxygen saturation, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 17 Apr 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.
The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: SupplementOne sachet of supplement before breakfast and dinner |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne sachet of inert compound before breakfast and dinner |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-30 years
- Absence of metabolic disorders or other health complications
- Provision of signed informed consent
Key exclusion criteria (3 listed)
- History of dietary supplement use within the preceding 4 weeks
- Lack of consent to randomization
- Concurrent participation in other studies
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 |
|---|---|---|
| SupplementDietary supplement containing creatine and guanidinoacetic acid | Dietary supplement | Supplement |
| PlaceboInert substance | Dietary supplement | Placebo |
Primary outcome
Brain oxygen saturation
Time frame: Change from baseline brain oxygen saturation at 2 weeks
Percentage of oxygen saturation in prefrontal brain
1 secondary outcome
Hemoglobin index
Time frame: Change from baseline hemoglobin index at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 11985880Watanabe A, Kato N, Kato T. Effects of creatine on mental fatigue and cerebral hemoglobin oxygenation. Neurosci Res. 2002 Apr;42(4):279-85. doi: 10.1016/s0168-0102(02)00007-x.
- Background: PubMed 20570601Hammett ST, Wall MB, Edwards TC, Smith AT. Dietary supplementation of creatine monohydrate reduces the human fMRI BOLD signal. Neurosci Lett. 2010 Aug 2;479(3):201-5. doi: 10.1016/j.neulet.2010.05.054. Epub 2010 May 24.
- Derived from this study: PubMed 39569437Zanini D, Todorovic N, Ostojic SM. Creatine with guanidinoacetic acid improves prefrontal brain oxygenation before, during, and after a cognitive task: A randomized controlled pilot trial. Nutr Health. 2025 Jun;31(2):363-368. doi: 10.1177/02601060241300236. Epub 2024 Nov 21.
- Web page of study labLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in nutritional neuroscience. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
Sergej Ostojic, MD, PhD principal investigator
University of Novi Sad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Oxygen Deficiency, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain oxygen saturation (time frame: Change from baseline brain oxygen saturation at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371651, which also lists 3 linked publications.
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 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.