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Completed

NCT Number: NCT04652921

Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 70 years
  • Free of acute disorders

Exclusion criteria

  • History of dietary supplement use during the past 4 weeks

Treatment and study plan

Creatine-guanidinoacetic acid

Dietary Supplement

A dietary supplement provided as powder dissolved in a glass of water

Inulin

Other

A dietary supplement provided as powder dissolved in a glass of water

Primary outcomes

  1. Change in muscular strength

    Time frame: Baseline vs. 6 months post-intervention

    Baseline vs. 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study title

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

Acronym: CREGAAS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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