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

NCT03350282 | Completed DMC

• 1 other identifier: SSD-01
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Energy Metabolism

Outcome Measures

Primary Outcomes (1)

• Brain creatine

  Rise in brain creatine levels

  Baseline vs 4-week follow up

Secondary Outcomes (1)

• Vastus medialis creatine

  Baseline vs 4-week follow up

Study Arms (2)

Mixture GAA-creatine

EXPERIMENTAL

Mixture of guanidinoacetic acid and creatine monohydrate

Dietary Supplement: GAA-creatine

Creatine

ACTIVE COMPARATOR

Creatine monohydrate

Dietary Supplement: Creatine

Interventions

GAA-creatine DIETARY_SUPPLEMENT

Mixture GAA-creatine

Creatine DIETARY_SUPPLEMENT

Creatine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• serum homocysteine \> 15 µmol/L
• use of dietary supplement (\> 1 month)

Sponsors & Collaborators

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

Related Publications (2)

• 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.

  PMID: 28460226 BACKGROUND

• Semeredi S, Stajer V, Ostojic J, Vranes M, Ostojic SM. Guanidinoacetic acid with creatine compared with creatine alone for tissue creatine content, hyperhomocysteinemia, and exercise performance: A randomized, double-blind superiority trial. Nutrition. 2019 Jan;57:162-166. doi: 10.1016/j.nut.2018.04.009. Epub 2018 May 17.

  PMID: 30170305 DERIVED

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sergej Ostojic, MD, PhD

  University of Novi Sad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: December 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available from January 2018