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NCT Number: NCT07285226

Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study

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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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Sciences

Belgrade, 11000, Serbia

Location status: Recruiting

Location contact

Nikola Todorovic, PhD

PRINCIPAL_INVESTIGATOR

Sergej M Ostojic, MD, PhD

CONTACT

[email protected]

+381-11-2643-242

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental 1

Dietary Supplement

Creatine HCl

Experimental 2

Dietary Supplement

Innulin (placebo)

Primary outcomes

  1. Hand-grip strength

    Time frame: 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 outcomes

  1. Senior fitness test score

    Time frame: 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.

  2. Mini-Mental State Examination Score

    Time frame: 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.

  3. Appendicular muscle mass

    Time frame: 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.

  4. Brain creatine

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

    Magnetic resonance spectra for brain creatine concentrations

  5. Irisin

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

    Serum levels of irisin

Study contacts

Contact information is provided by the study sponsor or research team.

Nikola Todorovic

CONTACT

[email protected]

+381112643242

Sergej Ostojic, MD, PhD

CONTACT

[email protected]

+381112643242

Sponsors and collaborators

Lead sponsor

Center for Health Sciences, Serbia

Other

Registry information

Official study title

Impact of 12-Week Creatine HCl Supplementation on Body Composition, Functional Muscle and Brain Performance, Blood Biomarkers, and Tissue Creatine Levels in Older Adults With Sarcopenia

Acronym: SARCOPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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