Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance
Primary Purpose
Energy Metabolism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GAA-creatine
Creatine
Sponsored by
About this trial
This is an interventional treatment trial for Energy Metabolism
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mixture GAA-creatine
Creatine
Arm Description
Mixture of guanidinoacetic acid and creatine monohydrate
Creatine monohydrate
Outcomes
Primary Outcome Measures
Brain creatine
Rise in brain creatine levels
Secondary Outcome Measures
Vastus medialis creatine
Rise in vastus medialis creatine creatine levels
Full Information
NCT ID
NCT03350282
First Posted
November 17, 2017
Last Updated
May 3, 2018
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT03350282
Brief Title
Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance
Official Title
Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance: a Randomized Double-blind Superiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Energy Metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mixture GAA-creatine
Arm Type
Experimental
Arm Description
Mixture of guanidinoacetic acid and creatine monohydrate
Arm Title
Creatine
Arm Type
Active Comparator
Arm Description
Creatine monohydrate
Intervention Type
Dietary Supplement
Intervention Name(s)
GAA-creatine
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine
Primary Outcome Measure Information:
Title
Brain creatine
Description
Rise in brain creatine levels
Time Frame
Baseline vs 4-week follow up
Secondary Outcome Measure Information:
Title
Vastus medialis creatine
Description
Rise in vastus medialis creatine creatine levels
Time Frame
Baseline vs 4-week follow up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergej Ostojic, MD, PhD
Organizational Affiliation
University of Novi Sad
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared via institutional repository
IPD Sharing Time Frame
Data will be available from January 2018
Citations:
PubMed Identifier
28460226
Citation
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.
Results Reference
background
PubMed Identifier
30170305
Citation
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.
Results Reference
derived
Learn more about this trial
Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance
We'll reach out to this number within 24 hrs