Sarcopenia
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTExperimental 1
Creatine HCl
DIETARY_SUPPLEMENTExperimental 2
Innulin (placebo)
Sponsors
Center for Health Sciences, Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand-grip strength | Change from baseline hand-grip strength at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Senior fitness test score | Change from baseline senior fitness test score at 12 weeks | 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. |
| Mini-Mental State Examination Score | Change from baseline Mini-Mental State Examination Score at 12 weeks | 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. |
| Appendicular muscle mass | Change from baseline appendicular muscle mass at 12 weeks | 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. |
| Brain creatine | Change from baseline brain creatine concentrations at 12 weeks | Magnetic resonance spectra for brain creatine concentrations |
| Irisin | Change from baseline serum levels of irisin at 12 weeks | Serum levels of irisin |
Countries
Serbia
Contacts
Primary ContactSergej Ostojic, MD, PhD
Backup ContactNikola Todorovic
Outcome results
None listed