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Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance

Sponsor
University of Novi Sad, Faculty of Sport and Physical Education (Other)
Overall Status
Completed
CT.gov ID
NCT03350282
Collaborator
(none)
14
Enrollment
2
Arms
17
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: GAA-creatine
  • Dietary Supplement: Creatine
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance: a Randomized Double-blind Superiority Trial
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mixture GAA-creatine

Mixture of guanidinoacetic acid and creatine monohydrate

Dietary Supplement: GAA-creatine
Active Comparator: Creatine

Creatine monohydrate

Dietary Supplement: Creatine

Outcome Measures

Primary Outcome Measures

  1. Brain creatine [Baseline vs 4-week follow up]

    Rise in brain creatine levels

Secondary Outcome Measures

  1. Vastus medialis creatine [Baseline vs 4-week follow up]

    Rise in vastus medialis creatine creatine levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Study Chair: Sergej Ostojic, MD, PhD, University of Novi Sad

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier:
NCT03350282
Other Study ID Numbers:
  • SSD-01
First Posted:
Nov 22, 2017
Last Update Posted:
May 4, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hyperhomocysteinemia

Study Results

No Results Posted as of May 4, 2018