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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04652921
Other study ID # DS-04/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 31, 2021

Study information

Verified date October 2022
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive pathological facet of this condition, and this might be approached with targeted therapies in aim to restore creatine homeostasis in target tissues. Among potential therapeutic candidates, guanidinoacetate (GAA) appears recently as a direct precursor of creatine that may favorably upregulate muscle and brain creatine concentration. Interestingly, GAA-creatine mixture was found to be superior than creatine itself to effectively improves bioenergetics in the human brain and muscle in healthy humans, perhaps due to the unique transportability features of this combination. Here, we plan to evaluate does creatine-GAA supplementation affects various biomarkers of sarcopenia in elderly.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - Age > 70 years - Free of acute disorders Exclusion Criteria: - History of dietary supplement use during the past 4 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Creatine-guanidinoacetic acid
A dietary supplement provided as powder dissolved in a glass of water
Other:
Inulin
A dietary supplement provided as powder dissolved in a glass of water

Locations

Country Name City State
Serbia Applied Bioenergetics Lab at Faculty of Sport and PE Novi Sad Vojvodina

Sponsors (1)

Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in muscular strength Baseline vs. 6 months Baseline vs. 6 months post-intervention
Secondary Change in muscle mass Baseline vs. 6 months Baseline vs. 6 months post-intervention
Secondary Change in muscle metabolites evaluated with MR spectroscopy Baseline vs. 6 months Baseline vs. 6 months post-intervention
Secondary Change in cognitive performance evaluated with Mini-Mental State Exam test Baseline vs. 6 months Baseline vs. 6 months post-intervention
Secondary Change in serum creatine Baseline vs. 6 months Baseline vs. 6 months post-intervention
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