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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06371651
Other study ID # 23-1462-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date April 12, 2024

Study information

Verified date May 2024
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date April 12, 2024
Est. primary completion date April 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Age 18-30 years - Absence of metabolic disorders or other health complications - Provision of signed informed consent Exclusion Criteria: - History of dietary supplement use within the preceding 4 weeks - Lack of consent to randomization - Concurrent participation in other studies

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Supplement
Dietary supplement containing creatine and guanidinoacetic acid
Placebo
Inert substance

Locations

Country Name City State
Serbia Applied Bioenergetics Lab at Faculty of Sport and PE Novi Sad Vojvodina

Sponsors (1)

Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brain oxygen saturation Percentage of oxygen saturation in prefrontal brain Change from baseline brain oxygen saturation at 2 weeks
Secondary Hemoglobin index Concentration of hemoglobin index in prefrontal brain Change from baseline hemoglobin index at 2 weeks
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