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Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS) (CREGAAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652921
Recruitment Status : Active, not recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Novi Sad, Faculty of Sport and Physical Education

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Creatine-guanidinoacetic acid Other: Inulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: The Effects of 6-month Supplementation With Creatine and Guanidinoacetic Acid on Biomarkers of Sarcopenia in Elderly
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Creatine-guanidinoacetic acid
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
A dietary supplement provided as powder dissolved in a glass of water

Placebo Comparator: Inulin
4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening
Other: Inulin
A dietary supplement provided as powder dissolved in a glass of water




Primary Outcome Measures :
  1. Change in muscular strength [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months


Secondary Outcome Measures :
  1. Change in muscle mass [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  2. Change in muscle metabolites evaluated with MR spectroscopy [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  3. Change in cognitive performance evaluated with Mini-Mental State Exam test [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months

  4. Change in serum creatine [ Time Frame: Baseline vs. 6 months post-intervention ]
    Baseline vs. 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 70 years
  • Free of acute disorders

Exclusion Criteria:

  • History of dietary supplement use during the past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652921


Locations
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Serbia
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
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Responsible Party: University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier: NCT04652921    
Other Study ID Numbers: DS-04/2020
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical