SarcopeniaSARCOPANCT07285226
Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study
A study testing Experimental 1 and Experimental 2 in people with Sarcopenia, run by Center for Health Sciences, Serbia at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Experimental 1 and Experimental 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Dec 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing interventional treatment for sarcopenia
- Physical amputation
- Cognitive impairment (MSSE < 25)
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
Center for Health Sciences
Belgrade, 11000
Sergej M Ostojic, MD, PhD, +381-11-2643-242, sergej.ostojic@chess.edu.rs
Nikola Todorovic, PhD
About this study
Official 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
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.
- Conditions
- Sarcopenia
- Being tested
- Experimental 1, Experimental 2
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 1Dietary supplement
Creatine HCl
Experimental 2Dietary supplement
Innulin (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | 2 capsules of creatine HCl per day Receives: Dietary Supplement: Experimental 1 |
| Experimental 2 | Placebo comparator | 2 capsules of inulin HCl per day Receives: Dietary Supplement: Experimental 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline hand-grip strength at 12 weeks
Secondary outcomes (5)
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.
Measured: Change from baseline senior fitness test score at 12 weeks
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.
Measured: 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.
Measured: Change from baseline appendicular muscle mass at 12 weeks
Brain creatine
Magnetic resonance spectra for brain creatine concentrations
Measured: Change from baseline brain creatine concentrations at 12 weeks
Irisin
Serum levels of irisin
Measured: Change from baseline serum levels of irisin at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Health Sciences, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergej Ostojic, MD, PhD, Study chair, Center for Mitochondrial Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285226
- Sponsor's protocol ID
- 4005-31-01
- Acronym
- SARCOPA
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39545789Korovljev 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.
PubMed 40854087Tuckfield 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.
PubMed 25877121
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07285226
- Acronym / sponsor ID
- SARCOPA / 4005-31-01
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Center for Health Sciences, SerbiaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Dietary Supplement: Experimental 12 capsules of creatine HCl per day |
| Experimental 2 | Placebo comparator | Dietary Supplement: Experimental 22 capsules of inulin HCl per day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Patients undergoing interventional treatment for sarcopenia
- Physical amputation
- Cognitive impairment (MSSE < 25)
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental 1Creatine HCl | Dietary supplement | Experimental 1 |
| Experimental 2Innulin (placebo) | Dietary supplement | Experimental 2 |
Primary outcome
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.
5 secondary outcomes
Senior fitness test score
Time frame: 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
Appendicular muscle mass
Time frame: Change from baseline appendicular muscle mass at 12 weeks
Brain creatine
Time frame: Change from baseline brain creatine concentrations at 12 weeks
Irisin
Time frame: Change from baseline serum levels of irisin at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 39545789Eghbali 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.
- Background: PubMed 40854087Korovljev 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.
- Background: PubMed 25877121Tuckfield 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Sarcopenia
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergej Ostojic, MD, PhD study chair
Center for Mitochondrial Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental 1 and Experimental 2 in people with Sarcopenia, run by Center for Health Sciences, Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergej Ostojic, MD, PhD (+381112643242, sergej.ostojic@chess.edu.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-grip strength (time frame: Change from baseline hand-grip strength at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285226, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.