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

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ClinicalTrials.gov Identifier: NCT03350282
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Novi Sad, Faculty of Sport and Physical Education

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
Energy Metabolism Dietary Supplement: GAA-creatine Dietary Supplement: Creatine Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : December 1, 2016
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018


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



Primary Outcome Measures :
  1. Brain creatine [ Time Frame: Baseline vs 4-week follow up ]
    Rise in brain creatine levels


Secondary Outcome Measures :
  1. Vastus medialis creatine [ Time Frame: Baseline vs 4-week follow up ]
    Rise in vastus medialis creatine creatine levels



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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350282


Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
Investigators
Study Chair: Sergej Ostojic, MD, PhD University of Novi Sad

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier: NCT03350282     History of Changes
Other Study ID Numbers: SSD-01
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared via institutional repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available from January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs