Creatine and GAA for Brain Oxygenation | NCT06371651

Studies
Creatine and GAA for Brain Oxygenation

NCT06371651

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Status

Completed

Last Update Posted

May 9, 2024Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Oxygen Deficiency

Interventions

Supplement
Placebo

Countries

Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Apr 10, 2024Actual

Completion Date

Apr 12, 2024Actual

First Submitted Date

Apr 14, 2024

First Submission Date that Met QC Criteria

Apr 14, 2024

First Posted Date

Apr 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2024

Last Update Posted Date

May 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sergej Ostojic, Professor, University of Novi Sad, Faculty of Sport and Physical EducationPrincipal Investigator

Lead Sponsor

University of Novi Sad, Faculty of Sport and Physical EducationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Supplement	Dietary Supplement	Dietary supplement containing creatine and guanidinoacetic acid	Supplement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergej Ostojic, MD, PhD	University of Novi Sad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Applied Bioenergetics Lab at Faculty of Sport and PE		Novi Sad	Vojvodina	21000	Serbia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11985880	Background	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.
20570601	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.

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages