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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03350282
Other study ID # SSD-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date May 1, 2018

Study information

Verified date May 2018
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

Co-administration of creatine and guanidinoacetic acid (GAA) has been recently put forward as an advanced dietary strategy to optimize tissue bioenergetics. The investigators hypothesized that creatine-GAA mixture would result in more powerful rise in brain and skeletal muscle creatine, as compared to creatine supplementation alone.


Description:

Targeting energy-demanding tissues in health and disease continues to be a challenging task in human nutrition and biomedicine. Impaired bioenergetics accompanies many different conditions, including cardiometabolic diseases, neurodegenerative disorders or high-intensity exercise, with various dietary interventions developed to restore cellular energy. Creatine is recognized as a beneficial and safe energy-boosting agent in both athletic and clinical environments. However, its effectiveness in specific conditions seems to be fairly restrained due to its limits in transportability and performance. Guanidinoacetic acid (GAA), a metabolic precursor of creatine, appears as a novel energy-enhancing supplement, with GAA being superior to creatine in facilitating creatine concentrations in the human brain and skeletal muscle. This perhaps happens due to GAA interaction with cellular transporters previously dismissed as untargetable carriers by other similar therapeutics. On the other hand, GAA loading remains under scrutiny due to its hyperhomocysteinemia-inducing potential, and possible neurotoxic effects. Co-administration of creatine and GAA has been recently proposed as a better strategy comparing to administration of each compound per se. Besides providing a competitive advantage for enhanced levels of tissue creatine, GAA-creatine mixture might also diminish side effects related to isolated GAA administration. However, no human studies so far evaluated the effects of this mixture. In the present study, the investigators compared the impact of 4-week co-administration of GAA and creatine vs. creatine administration alone on serum biomarkers, exercise performance and tissue bioenergetics in healthy young men.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- men age 18-45 years

- BMI 18.5-24.9 kg/m2

- physically active (> 150 min per week)

- free of known disease

- must be able to give written informed consent

Exclusion Criteria:

- serum homocysteine > 15 µmol/L

- use of dietary supplement (> 1 month)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
GAA-creatine

Creatine


Locations

Country Name City State
n/a

Sponsors (1)

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

References & Publications (1)

Ostojic SM. Co-administration of creatine and guanidinoacetic acid for augmented tissue bioenergetics: A novel approach? Biomed Pharmacother. 2017 Jul;91:238-240. doi: 10.1016/j.biopha.2017.04.075. Epub 2017 Apr 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brain creatine Rise in brain creatine levels Baseline vs 4-week follow up
Secondary Vastus medialis creatine Rise in vastus medialis creatine creatine levels Baseline vs 4-week follow up
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