Menopausal, Perimenopause
Conditions
Keywords
creatine, brain metabolism, cognition, fatigue
Brief 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 menopausal women
Interventions
DIETARY_SUPPLEMENTDietary Supplement: Experimental 1 Creatine HCl
Creatine hcl
DIETARY_SUPPLEMENTDietary Supplement: Experimental 2 Creatine HCl
Creatine hcl
DIETARY_SUPPLEMENTDietary Supplement: Experimental 3 Creatine Ethyl ester
Creatine ethyl ester
DIETARY_SUPPLEMENTDietary Supplement: Experimental 4 Placebo
Placebo
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Change from baseline fatigue at 8 weeks | Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to exhaustion | Change from baseline time to exhaustion at 8 weeks | Running time to exhaustion during incrementaltestontreadmill |
| Brain creatine | Change from baseline brain creatine concentrations at 8 weeks | Magnetic resonance spectra for brain creatine concentrations |
| Cognitive interference | Change from baseline fatigue at 8 weeks | Ability to inhibit cognitive interference as assessed by the The Stroop Color and Word Test |
| Amyloid b | Change from baseline time to exhaustion at 8 weeks | Serum levels of amyloid b |
Countries
Serbia
Outcome results
None listed