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CompletedNCT06371651CREGAA-OXYUpdated May 9, 2024

Creatine and GAA for Brain Oxygenation

An interventional study of Supplement and Placebo in Oxygen Deficiency, sponsored by University of Novi Sad, Faculty of Sport and Physical Education. Completed at 1 site in Serbia. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University of Novi Sad, Faculty of Sport and Physical Education · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Oxygen Deficiency

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Keywords

  • creatine
  • guanidinoacetic acid
  • oxygen saturation
  • brain
03

In context

Hypoxia

1,246 studies on the registry are indexed under Hypoxia; 239 are open to participants now.

This study's enrollment of 19 is below the median of 45 across 864 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-30 years
  • Absence of metabolic disorders or other health complications
  • Provision of signed informed consent

Exclusion criteria

Exclusion Criteria:

  • History of dietary supplement use within the preceding 4 weeks
  • Lack of consent to randomization
  • Concurrent participation in other studies
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Supplement

    One sachet of supplement before breakfast and dinner

    Dietary Supplement: Supplement

  • Placebo comparator
    Placebo

    One sachet of inert compound before breakfast and dinner

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementSupplement

    Dietary supplement containing creatine and guanidinoacetic acid

  • Dietary supplementPlacebo

    Inert substance

06

What researchers measure

Primary outcomes

  1. Brain oxygen saturation

    Percentage of oxygen saturation in prefrontal brain

    Time frame: Change from baseline brain oxygen saturation at 2 weeks

Secondary outcomes

  1. Hemoglobin index

    Concentration of hemoglobin index in prefrontal brain

    Time frame: Change from baseline hemoglobin index at 2 weeks

07

Study locations

1 site
  • Applied Bioenergetics Lab at Faculty of Sport and PE
    Novi Sad, Vojvodina 21000, Serbia
08

References and documents

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 11985880 ↗
  • Hammett 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 20570601 ↗
  • Zanini 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.

Access criteria: Only qualified researchers with academic interest in in nutritional neuroscience

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06371651
Lead sponsor
University of Novi Sad, Faculty of Sport and Physical Education
Responsible party
Sergej Ostojic (Professor, University of Novi Sad, Faculty of Sport and Physical Education) — Principal investigator
First posted
Apr 17, 2024
Start date
Mar 1, 2024
Primary completion
Apr 10, 2024
Completion
Apr 12, 2024
Last update
May 9, 2024

Study contacts

Sergej Ostojic, MD, PhD
principal investigator · University of Novi Sad

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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