Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of 6-month Supplementation With Creatine and Guanidinoacetic Acid on Biomarkers of Sarcopenia in Elderly

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Creatine-guanidinoacetic acid
* Other: Inulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 70 years Free of acute disorders Exclusion Criteria: History of dietary supplement use during the past 4 weeks

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine-guanidinoacetic acid<br>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 | Dietary Supplement: Creatine-guanidinoacetic acid<br>* A dietary supplement provided as powder dissolved in a glass of water<br>|
| Placebo Comparator: Inulin<br>4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening | Other: Inulin<br>* A dietary supplement provided as powder dissolved in a glass of water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscular strength | Baseline vs. 6 months | Baseline vs. 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass | Baseline vs. 6 months | Baseline vs. 6 months post-intervention | 
| Change in muscle metabolites evaluated with MR spectroscopy | Baseline vs. 6 months | Baseline vs. 6 months post-intervention | 
| Change in cognitive performance evaluated with Mini-Mental State Exam test | Baseline vs. 6 months | Baseline vs. 6 months post-intervention | 
| Change in serum creatine | Baseline vs. 6 months | Baseline vs. 6 months post-intervention |