Creatine and GAA for Brain Oxygenation

NCT06371651 | Completed

• 1 other identifier: 23-1462-3
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Deficiency

Keywords

creatine; guanidinoacetic acid; oxygen saturation; brain

Outcome Measures

Primary Outcomes (1)

• Brain oxygen saturation

  Percentage of oxygen saturation in prefrontal brain

  Change from baseline brain oxygen saturation at 2 weeks

Secondary Outcomes (1)

• Hemoglobin index

  Change from baseline hemoglobin index at 2 weeks

Study Arms (2)

Supplement

EXPERIMENTAL

One sachet of supplement before breakfast and dinner

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

One sachet of inert compound before breakfast and dinner

Dietary Supplement: Placebo

Interventions

Supplement DIETARY_SUPPLEMENT

Dietary supplement containing creatine and guanidinoacetic acid

Supplement

Placebo DIETARY_SUPPLEMENT

Inert substance

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (3)

• 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.

  PMID: 11985880 BACKGROUND

• 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.

  PMID: 20570601 BACKGROUND

• 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.

  PMID: 39569437 DERIVED

Related Links

• Web page of study lab

MeSH Terms

Conditions

Hypoxia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sergej Ostojic, MD, PhD

  University of Novi Sad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: March 1, 2024
• Primary Completion: April 10, 2024
• Study Completion: April 12, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

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

Locations

SE (1)