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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | 2 capsules of creatine HCl per day |
|
| Experimental 2 | Placebo Comparator | 2 capsules of inulin HCl per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 1 | Dietary Supplement | Creatine HCl |
| |
| Experimental 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline hand-grip strength at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline senior fitness test score at 12 weeks |
| Mini-Mental State Examination Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergej Ostojic, MD, PhD | Contact | +381112643242 | sergej.ostojic@chess.edu.rs | |
| Nikola Todorovic | Contact | +381112643242 | nikola.todorovic@appliedbioenergetics.org |
| Name | Affiliation | Role |
|---|---|---|
| Sergej Ostojic, MD, PhD | Center for Mitochondrial Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Health Sciences | Recruiting | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39545789 | Background | Eghbali E, Arazi H, Suzuki K. Supplementing With Which Form of Creatine (Hydrochloride or Monohydrate) Alongside Resistance Training Can Have More Impacts on Anabolic/Catabolic Hormones, Strength and Body Composition? Physiol Res. 2024 Nov 15;73(5):739-753. doi: 10.33549/physiolres.935323. | |
| 40854087 | Background |
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Data obtained through this study may be provided to qualified researchers with academic interest in sarcopenia. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Dietary Supplement |
Innulin (placebo) |
|
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. |
| 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. | Change from baseline appendicular muscle mass at 12 weeks |
| Brain creatine | Magnetic resonance spectra for brain creatine concentrations | Change from baseline brain creatine concentrations at 12 weeks |
| Irisin | Serum levels of irisin | Change from baseline serum levels of irisin at 12 weeks |
| Korovljev D, Ostojic J, Panic J, Ranisavljev M, Todorovic N, Nedeljkovic D, Kuzmanovic J, Vranes M, Stajer V, Ostojic SM. The Effects of 8-Week Creatine Hydrochloride and Creatine Ethyl Ester Supplementation on Cognition, Clinical Outcomes, and Brain Creatine Levels in Perimenopausal and Menopausal Women (CONCRET-MENOPA): A Randomized Controlled Trial. J Am Nutr Assoc. 2026 Mar-Apr;45(3):199-210. doi: 10.1080/27697061.2025.2551184. Epub 2025 Aug 25. |
| 25877121 | Background | Tuckfield C. First use of creatine hydrochloride in premanifest Huntington disease. Med J Aust. 2015 Apr 20;202(7):378-80. doi: 10.5694/mja14.01070. No abstract available. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |