Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study

Center for Health Sciences, Serbia30 enrolled

Overview

The CONCRET-SARCOPA trial is a 12-week, double-blind, randomized controlled study designed to evaluate the efficacy of creatine HCl supplementation in older adults with sarcopenia. The trial investigates whether daily creatine HCl improves body composition, enhances functional muscle and cognitive performance, and favorably alters key blood biomarkers associated with muscle health and metabolic status. Additionally, the study assesses changes in tissue creatine levels using non-invasive and biochemical methods to clarify mechanistic responses to supplementation. Findings from this trial will provide critical evidence on the therapeutic potential of creatine HCl as a targeted nutritional strategy for managing sarcopenia in the geriatric population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sarcopenia

Interventions

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 60 years * Low muscle strength by handgrip (SDOC criteria for sarcopenia): \< 35.5 kg in men and \< 20 kg in women * Sign free and informed consent * Demonstrate interest, conditions and availability to participate Exclusion Criteria: * Patients undergoing interventional treatment for sarcopenia * Physical amputation * Cognitive impairment (MSSE \< 25) * Unwillingness to return for follow-up analysis * Participation in other clinical trials

Outcomes

Primary Outcomes

Hand-grip strength

Handgrip strength quantifies maximal voluntary force generated by the hand using a dynamometer, serving as a simple, reliable indicator of overall muscle function and sarcopenia severity.

Time frame: Change from baseline hand-grip strength at 12 weeks

Secondary Outcomes

Senior fitness test score

The Senior Fitness Test score reflects aggregated performance across multiple functional tasks, providing a quantifiable index of an older adult's overall physical capability, mobility, and age-related fitness status.

Time frame: Change from baseline senior fitness test score at 12 weeks

Mini-Mental State Examination Score

The Mini-Mental State Examination score quantifies global cognitive function by assessing orientation, memory, attention, language, and visuospatial abilities, offering a validated measure for detecting cognitive decline in older adults.

Time frame: Change from baseline Mini-Mental State Examination Score at 12 weeks

Appendicular muscle mass

Appendicular muscle mass quantifies lean soft tissue in arms and legs serving as a key indicator of skeletal muscle quantity and sarcopenia-related muscle depletion.

Time frame: Change from baseline appendicular muscle mass at 12 weeks

Brain creatine

Magnetic resonance spectra for brain creatine concentrations

Time frame: Change from baseline brain creatine concentrations at 12 weeks

Irisin

Serum levels of irisin

Time frame: Change from baseline serum levels of irisin at 12 weeks