Back to resultsCreatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS) (CREGAAS)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Creatine-guanidinoacetic acid
Inulin
Sponsored by
About this trial
This is an interventional basic science trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- Age > 70 years
- Free of acute disorders
Exclusion Criteria:
- History of dietary supplement use during the past 4 weeks
Sites / Locations
- Applied Bioenergetics Lab at Faculty of Sport and PE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Creatine-guanidinoacetic acid
Inulin
Arm Description
2 grams of creatine and 2 grams of GAA Administered one dose two times per day on an empty stomach in the morning and at the evening
4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening
Outcomes
Primary Outcome Measures
Change in muscular strength
Baseline vs. 6 months
Secondary Outcome Measures
Change in muscle mass
Baseline vs. 6 months
Change in muscle metabolites evaluated with MR spectroscopy
Baseline vs. 6 months
Change in cognitive performance evaluated with Mini-Mental State Exam test
Baseline vs. 6 months
Change in serum creatine
Baseline vs. 6 months
Full Information
NCT ID
NCT04652921
First Posted
November 26, 2020
Last Updated
October 31, 2022
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT04652921
Brief Title
Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)
Acronym
CREGAAS
Official Title
The Effects of 6-month Supplementation With Creatine and Guanidinoacetic Acid on Biomarkers of Sarcopenia in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 31, 2021 (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
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Creatine-guanidinoacetic acid
Arm Type
Experimental
Arm Description
2 grams of creatine and 2 grams of GAA Administered one dose two times per day on an empty stomach in the morning and at the evening
Arm Title
Inulin
Arm Type
Placebo Comparator
Arm Description
4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine-guanidinoacetic acid
Intervention Description
A dietary supplement provided as powder dissolved in a glass of water
Intervention Type
Other
Intervention Name(s)
Inulin
Intervention Description
A dietary supplement provided as powder dissolved in a glass of water
Primary Outcome Measure Information:
Title
Change in muscular strength
Description
Baseline vs. 6 months
Time Frame
Baseline vs. 6 months post-intervention
Secondary Outcome Measure Information:
Title
Change in muscle mass
Description
Baseline vs. 6 months
Time Frame
Baseline vs. 6 months post-intervention
Title
Change in muscle metabolites evaluated with MR spectroscopy
Description
Baseline vs. 6 months
Time Frame
Baseline vs. 6 months post-intervention
Title
Change in cognitive performance evaluated with Mini-Mental State Exam test
Description
Baseline vs. 6 months
Time Frame
Baseline vs. 6 months post-intervention
Title
Change in serum creatine
Description
Baseline vs. 6 months
Time Frame
Baseline vs. 6 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 70 years
Free of acute disorders
Exclusion Criteria:
History of dietary supplement use during the past 4 weeks
Facility Information:
Facility Name
Applied Bioenergetics Lab at Faculty of Sport and PE
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)
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