Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)

NCT04652921 | Completed

• 1 other identifier: DS-04/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change in muscular strength

  Baseline vs. 6 months

  Baseline vs. 6 months post-intervention

Secondary Outcomes (4)

• Change in muscle mass

  Baseline vs. 6 months post-intervention

• Change in muscle metabolites evaluated with MR spectroscopy

  Baseline vs. 6 months post-intervention

• Change in cognitive performance evaluated with Mini-Mental State Exam test

  Baseline vs. 6 months post-intervention

• Change in serum creatine

  Baseline vs. 6 months post-intervention

Study Arms (2)

Creatine-guanidinoacetic acid

EXPERIMENTAL

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

Inulin

PLACEBO COMPARATOR

4 grams of inulin Administered one dose two times per day on an empty stomach in the morning and at the evening

Other: Inulin

Interventions

Creatine-guanidinoacetic acid DIETARY_SUPPLEMENT

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

Creatine-guanidinoacetic acid

Inulin OTHER

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

Inulin

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 70 years
• Free of acute disorders

You may not qualify if:

• History of dietary supplement use during the past 4 weeks

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Inulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: September 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)