Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study (SARCOPA)

December 27, 2025 updated by: Center for Health Sciences, Serbia

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Center for Health Sciences
        • Contact:
        • Principal Investigator:
          • Nikola Todorovic, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
2 capsules of creatine HCl per day
Dietary supplement: Experimental 1
Creatine HCl
Placebo Comparator: Experimental 2
2 capsules of inulin HCl per day
Dietary supplement: Experimental 2
Innulin (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline hand-grip strength at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline senior fitness test score at 12 weeks
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.
Change from baseline Mini-Mental State Examination Score at 12 weeks
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.
Change from baseline appendicular muscle mass at 12 weeks
Brain creatine
Time Frame: Change from baseline brain creatine concentrations at 12 weeks
Magnetic resonance spectra for brain creatine concentrations
Change from baseline brain creatine concentrations at 12 weeks
Irisin
Time Frame: Change from baseline serum levels of irisin at 12 weeks
Serum levels of irisin
Change from baseline serum levels of irisin at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Health Sciences, Serbia

Investigators

  • Study Chair: Sergej Ostojic, MD, PhD, Center for Mitochondrial Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 16, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 27, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4005-31-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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