Health TrialsbyHealthPanel

Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study

ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCenter for Health Sciences, Serbia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients undergoing interventional treatment for sarcopenia

Physical amputation

Cognitive impairment (MSSE < 25)

Unwillingness to return for follow-up analysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental 1

    Dietary supplement

    Creatine HCl

  • Experimental 2

    Dietary supplement

    Innulin (placebo)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Experimental 1Experimental treatment 1 intervention
Group B: Experimental 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

Brain creatine

Magnetic resonance spectra for brain creatine concentrations

Time frame
Change from baseline brain creatine concentrations at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Health Sciences, Serbia

Lead sponsor

Source ClinicalTrials.gov
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