Creatine and GAA for Brain Oxygenation (CREGAA-OXY)

May 6, 2024 updated by: Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement
One sachet of supplement before breakfast and dinner
Dietary supplement: Supplement
Dietary supplement containing creatine and guanidinoacetic acid
Placebo Comparator: Placebo
One sachet of inert compound before breakfast and dinner
Dietary supplement: Placebo
Inert substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain oxygen saturation
Time Frame: Change from baseline brain oxygen saturation at 2 weeks
Percentage of oxygen saturation in prefrontal brain
Change from baseline brain oxygen saturation at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin index
Time Frame: Change from baseline hemoglobin index at 2 weeks
Concentration of hemoglobin index in prefrontal brain
Change from baseline hemoglobin index at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Investigators

  • Principal Investigator: Sergej Ostojic, MD, PhD, University of Novi Sad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

April 10, 2024

Study Completion (Actual)

April 12, 2024

Study Registration Dates

First Submitted

April 14, 2024

First Submitted That Met QC Criteria

April 14, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1462-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Only qualified researchers with academic interest in in nutritional neuroscience

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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