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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine hcl | Experimental | One capsule per day of creatine hcl during breakfast |
|
| Creatine hcl 2 | Experimental | One capsule during breakfast and one during dinner of creatine hcl |
|
| Creatine ethyl ester | Experimental | One capsule during breakfast and one during dinner of creatine ethyl ester |
|
| Placebo | Placebo Comparator | One capsule per day of inulin during breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: Experimental 1 Creatine HCl | Dietary Supplement | Creatine hcl |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI) | Change from baseline fatigue at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to exhaustion | Running time to exhaustion during incrementaltestontreadmill | Change from baseline time to exhaustion at 8 weeks |
| Brain creatine | Magnetic resonance spectra for brain creatine concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergej Ostojic, MD, PhD | Applied BIoenergetics Lab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSPE Applied BIoenergetcis Lab | Novi Sad | Vojvodina | 21000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39055234 | Background | 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. | |
| 40854087 | Derived | Korovljev 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. |
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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.
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.
Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.
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| Dietary Supplement: Experimental 2 Creatine HCl |
| Dietary Supplement |
Creatine hcl |
|
| Dietary Supplement: Experimental 3 Creatine Ethyl ester | Dietary Supplement | Creatine ethyl ester |
|
| Dietary Supplement: Experimental 4 Placebo | Dietary Supplement | Placebo |
|
| 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 | Change from baseline fatigue at 8 weeks |
| Amyloid b | Serum levels of amyloid b | Change from baseline time to exhaustion at 8 weeks |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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