Guanidinoacetic Acid (GAA) Administration in Physically Active Men and Women

NCT01133899 | Completed Phase 1 DMC

• 1 other identifier: AN-85E-S09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Glycocyamine (guanidinoacetic acid - GAA) is the biochemical precursor of creatine, which is phosphorylated and plays an important role as a high-energy carrier in the muscle. Since GAA can be administered in liquid solutions, such as sports drinks, it could be hypothesised that GAA could easily enhance creatine biosynthesis with clear physiological effects yet to be determined. No single study has examined the influence of GAA on health, human performance or body composition indicators in healthy human subjects. Moreover, the most effective dose of GAA is yet to be find. Finally, the adverse effects of GAA supplementation in humans are not determined. The main aims of the present study will be to identify if the 6-weeks of GAA supplementation improves human performance and body composition, to determine most effective dose regimens of GAA, and to analyze adverse effects of GAA supplementation. Forty eight healthy, trained (\> 2 yr training experience) male and female subjects (aged 20 to 25 years) will give their informed consent and volunteer to participate in the study, which will obtain the approval of the University's Ethical Advisory Commission. The subjects will be allocated to four randomly assigned trials: ingesting GAA (1.2, 2.4, 4.8 g of GAA in a single dose) or placebo (PLA) for 6 weeks in a double-blind design. All testing including blood and urine samples, body composition and muscle strength and exercise performance (both aerobic and anaerobic) will be conducted at presupplementation (baseline), at 1 week, at 2 weeks, at 4 weeks, at 6 weeks of supplementation and at 8 and 10 weeks (2 and 4 weeks after the end of supplementation) to analyze wash-out period. According to previous investigations, the investigators expect that ingestion of GAA will significantly increase both serum creatine and total homocystein. The investigators expect that ingestion of GAA will significantly improve muscle strength parameters and exercise performance results as compared to placebo in long term. The investigators also expect to find prevalence of side-effects (i.e. gastrointestinal distress, retention of fluid).

Conditions

Athletic Performance

Keywords

strength, anaerobic performance, recovery, ergogenic

Outcome Measures

Primary Outcomes (1)

• Muscle power

  The majority of investigations involving the effects of creatine (or creatine precursors) supplementation on human performance were laboratory-based and have focused on musucular strength and power and anaerobic endurance, with various task protocols such as weght lifting, running, jumping and cycling less than or equal to 30 sec in duration. Similarly, the effects of GAA on exercise performance should be investigated with measuring muscle strength and power (through both isometric and isotonic exercise) and anaerobic endurance (e.g. repeated jumping performance).

  Baseline, at 1 week, at 2 weeks, at 4 weeks, at 6 weeks, at 8 weeks, at 10 weeks

Secondary Outcomes (1)

• Muscle mass

  Baseline, at 1 week, at 2 weeks, at 4 weeks, at 6 weeks, at 8 weeks and at 10 weeks

Study Arms (4)

GAA-2

EXPERIMENTAL

2.4 grams of guanidinoacetic acid

Dietary Supplement: guanidinoacetic acid

GAA-1

EXPERIMENTAL

1.2 grams of guanidinoacetic acid

Dietary Supplement: GAA-1

GAA-4

EXPERIMENTAL

4.8 grams of guanidinoacetic acid

Dietary Supplement: GAA-4

PLACEBO

PLACEBO COMPARATOR

cellulose

Dietary Supplement: PLACEBO

Interventions

guanidinoacetic acid DIETARY_SUPPLEMENT

2.4 grams of guanidinoacetic acid

GAA-2

GAA-4 DIETARY_SUPPLEMENT

4.8 grams of guanidinoacetic acid

GAA-4

GAA-1 DIETARY_SUPPLEMENT

1.2 grams of guanidinoacetic acid

GAA-1

PLACEBO DIETARY_SUPPLEMENT

celulose

PLACEBO

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy young men and women
• aged 20 to 25 years
• experienced in athletic training
• free from musculoskeletal dysfunctions
• free from metabolic and heart diseases
• participating in consistent training (average of three times per week)

You may not qualify if:

• current intake of dietary supplement containing performance-enhancing agent
• pregnant women
• current intake of hormonal contraceptives

Sponsors & Collaborators

• Metropolitan University, Serbia: lead

Study Sites (1)

Biomedical Scinces Department, Exercise Physiology Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (8)

• Setoue M, Ohuchi S, Morita T, Sugiyama K. Hyperhomocysteinemia induced by guanidinoacetic acid is effectively suppressed by choline and betaine in rats. Biosci Biotechnol Biochem. 2008 Jul;72(7):1696-703. doi: 10.1271/bbb.70791. Epub 2008 Jul 7.

  PMID: 18603787 BACKGROUND

• Ostojic SM. Creatine supplementation in young soccer players. Int J Sport Nutr Exerc Metab. 2004 Feb;14(1):95-103. doi: 10.1123/ijsnem.14.1.95.

  PMID: 15129933 BACKGROUND

• BORSOOK ME, BORSOOK H. Treatment of cardiac decompensation with betaine and glycocyamine. Ann West Med Surg. 1951 Oct;5(10):830-55. No abstract available.

  PMID: 14878414 BACKGROUND

• da Silva RP, Nissim I, Brosnan ME, Brosnan JT. Creatine synthesis: hepatic metabolism of guanidinoacetate and creatine in the rat in vitro and in vivo. Am J Physiol Endocrinol Metab. 2009 Feb;296(2):E256-61. doi: 10.1152/ajpendo.90547.2008. Epub 2008 Nov 18.

  PMID: 19017728 BACKGROUND

• Edison EE, Brosnan ME, Meyer C, Brosnan JT. Creatine synthesis: production of guanidinoacetate by the rat and human kidney in vivo. Am J Physiol Renal Physiol. 2007 Dec;293(6):F1799-804. doi: 10.1152/ajprenal.00356.2007. Epub 2007 Oct 10.

  PMID: 17928413 BACKGROUND

• Mudd SH, Poole JR. Labile methyl balances for normal humans on various dietary regimens. Metabolism. 1975 Jun;24(6):721-35. doi: 10.1016/0026-0495(75)90040-2.

  PMID: 1128236 BACKGROUND

• Ostojic SM, Stojanovic M, Drid P, Hoffman JR. Dose-response effects of oral guanidinoacetic acid on serum creatine, homocysteine and B vitamins levels. Eur J Nutr. 2014 Dec;53(8):1637-43. doi: 10.1007/s00394-014-0669-0. Epub 2014 Feb 18.

  PMID: 24535415 DERIVED

• Ostojic SM, Niess B, Stojanovic M, Obrenovic M. Creatine metabolism and safety profiles after six-week oral guanidinoacetic acid administration in healthy humans. Int J Med Sci. 2013;10(2):141-7. doi: 10.7150/ijms.5125. Epub 2013 Jan 3.

  PMID: 23329885 DERIVED

MeSH Terms

Interventions

glycocyamine

Study Officials

• Sergej M Ostojic, MD, PhD

  Biomedical Sciences Dept, Faculty of Sport Sciences and Tourism, Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Heaf of Exercise Physiology Lab

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: May 31, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 20, 2011

Record last verified: 2011-12

Locations

SE (1)