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

October 31, 2022 updated by: University of Novi Sad, Faculty of Sport and Physical Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 70 years
  • Free of acute disorders

Exclusion Criteria:

  • History of dietary supplement use during the past 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-04/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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