MenopausalCONCRET-MENOPANCT06660004
Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women
A study testing Dietary Supplement: Experimental 1 Creatine HCl, Dietary Supplement: Experimental 2 Creatine HCl and Dietary Supplement: Experimental 3 Creatine Ethyl ester in people with Menopausal and Perimenopause, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopausal, Perimenopause
- What is being tested?
- Dietary Supplement: Experimental 1 Creatine HCl, Dietary Supplement: Experimental 2 Creatine HCl and Dietary Supplement: Experimental 3 Creatine Ethyl ester
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Nov 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index 18.5 - 29.9 kg/m2
- Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score > 25 points)
- MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)
- PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties
- Given written informed consent
Who cannot join
- History of dietary supplement use 4 weeks before the study commences
- Pregnancy (or planning pregnancy)
- Abnormal values for lab clinical chemistry (> 2 SD)
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 8-Week Creatine HCl and Creatine Ethyl Ester Supplementation on Cognitive Performance, Multidimensional Fatigue, Brain Metabolism, and Biochemical Indices in Perimenopausal and Menopausal Women
The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women
- Conditions
- Menopausal, Perimenopause
- Being tested
- Dietary Supplement: Experimental 1 Creatine HCl, Dietary Supplement: Experimental 2 Creatine HCl, Dietary Supplement: Experimental 3 Creatine Ethyl ester, Dietary Supplement: Experimental 4 Placebo
- Keywords
- creatine, brain metabolism, cognition, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Experimental 1 Creatine HClDietary supplement
Creatine hcl
Dietary Supplement: Experimental 2 Creatine HClDietary supplement
Creatine hcl
Dietary Supplement: Experimental 3 Creatine Ethyl esterDietary supplement
Creatine ethyl ester
Dietary Supplement: Experimental 4 PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Creatine hcl | Experimental | One capsule per day of creatine hcl during breakfast Receives: Dietary Supplement: Dietary Supplement: Experimental 1 Creatine HCl |
| Creatine hcl 2 | Experimental | One capsule during breakfast and one during dinner of creatine hcl Receives: Dietary Supplement: Dietary Supplement: Experimental 2 Creatine HCl |
| Creatine ethyl ester | Experimental | One capsule during breakfast and one during dinner of creatine ethyl ester Receives: Dietary Supplement: Dietary Supplement: Experimental 3 Creatine Ethyl ester |
| Placebo | Placebo comparator | One capsule per day of inulin during breakfast Receives: Dietary Supplement: Dietary Supplement: Experimental 4 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
Measured: Change from baseline fatigue at 8 weeks
Secondary outcomes (4)
Time to exhaustion
Running time to exhaustion during incrementaltestontreadmill
Measured: Change from baseline time to exhaustion at 8 weeks
Brain creatine
Magnetic resonance spectra for brain creatine concentrations
Measured: Change from baseline brain creatine concentrations at 8 weeks
Cognitive interference
Ability to inhibit cognitive interference as assessed by the The Stroop Color and Word Test
Measured: Change from baseline fatigue at 8 weeks
Amyloid b
Serum levels of amyloid b
Measured: Change from baseline time to exhaustion at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Nov 2024
- Primary completion15 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopausalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
- Investigators
- Sergej Ostojic, MD, PhD, Principal investigator, Applied BIoenergetics Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660004
- Sponsor's protocol ID
- CC-1-24
- Acronym
- CONCRET-MENOPA
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2024
- Last updated
- 16 Dec 2025
- 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 perimenopause. 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
Ostojic SM, Stea TH, Ellery SJ, Smith-Ryan AE. Association between dietary intake of creatine and female reproductive health: Evidence from NHANES 2017-2020. Food Sci Nutr. 2024 Apr 30;12(7):4893-4898. doi: 10.1002/fsn3.4135. eCollection 2024 Jul.
PubMed 39055234Korovljev 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 40854087
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8-Week Creatine HCl and Creatine Ethyl Ester Supplementation on Cognitive Performance, Multidimensional Fatigue, Brain Metabolism, and Biochemical Indices in Perimenopausal and Menopausal Women
- ClinicalTrials.gov ID
- NCT06660004
- Acronym / sponsor ID
- CONCRET-MENOPA / CC-1-24
- Conditions
- Menopausal, Perimenopause
- Keywords
- creatine, brain metabolism, cognition, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 26 Oct 2024 (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 goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Creatine hcl | Experimental | Dietary Supplement: Dietary Supplement: Experimental 1 Creatine HClOne capsule per day of creatine hcl during breakfast |
| Creatine hcl 2 | Experimental | Dietary Supplement: Dietary Supplement: Experimental 2 Creatine HClOne capsule during breakfast and one during dinner of creatine hcl |
| Creatine ethyl ester | Experimental | Dietary Supplement: Dietary Supplement: Experimental 3 Creatine Ethyl esterOne capsule during breakfast and one during dinner of creatine ethyl ester |
| Placebo | Placebo comparator | Dietary Supplement: Dietary Supplement: Experimental 4 PlaceboOne capsule per day of inulin during breakfast |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index 18.5 - 29.9 kg/m2
- Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score > 25 points)
- MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)
- PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties
- Given written informed consent
Key exclusion criteria (5 listed)
- History of dietary supplement use 4 weeks before the study commences
- Pregnancy (or planning pregnancy)
- Abnormal values for lab clinical chemistry (> 2 SD)
- 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 |
|---|---|---|
| Dietary Supplement: Experimental 1 Creatine HClCreatine hcl | Dietary supplement | Creatine hcl |
| Dietary Supplement: Experimental 2 Creatine HClCreatine hcl | Dietary supplement | Creatine hcl 2 |
| Dietary Supplement: Experimental 3 Creatine Ethyl esterCreatine ethyl ester | Dietary supplement | Creatine ethyl ester |
| Dietary Supplement: Experimental 4 PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Fatigue
Time frame: Change from baseline fatigue at 8 weeks
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
4 secondary outcomes
Time to exhaustion
Time frame: Change from baseline time to exhaustion at 8 weeks
Brain creatine
Time frame: Change from baseline brain creatine concentrations at 8 weeks
Cognitive interference
Time frame: Change from baseline fatigue at 8 weeks
Amyloid b
Time frame: Change from baseline time to exhaustion at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 39055234Ostojic SM, Stea TH, Ellery SJ, Smith-Ryan AE. Association between dietary intake of creatine and female reproductive health: Evidence from NHANES 2017-2020. Food Sci Nutr. 2024 Apr 30;12(7):4893-4898. doi: 10.1002/fsn3.4135. eCollection 2024 Jul.
- Derived from this study: 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.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause. 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.
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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. This study is not recruiting at the moment.
Sergej Ostojic, MD, PhD principal investigator
Applied BIoenergetics Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Experimental 1 Creatine HCl, Dietary Supplement: Experimental 2 Creatine HCl and Dietary Supplement: Experimental 3 Creatine Ethyl ester in people with Menopausal and Perimenopause, run by University of Novi Sad, Faculty of Sport and Physical Education 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 5 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: finished, as of the sponsor's last update on 16 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Change from baseline fatigue at 8 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 NCT06660004, which also lists 2 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 16 Dec 2025.