Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women

University of Novi Sad, Faculty of Sport and Physical Education36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Menopausal Perimenopause

Interventions

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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

FSPE Applied BIoenergetcis Lab

Novi Sad, Vojvodina, Serbia

Outcomes

Primary Outcomes

Fatigue

Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

Time frame: Change from baseline fatigue at 8 weeks

Secondary Outcomes

Time to exhaustion

Running time to exhaustion during incrementaltestontreadmill

Time frame: Change from baseline time to exhaustion at 8 weeks

Brain creatine

Magnetic resonance spectra for brain creatine concentrations

Time frame: 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

Time frame: Change from baseline fatigue at 8 weeks

Amyloid b

Serum levels of amyloid b

Time frame: Change from baseline time to exhaustion at 8 weeks

Data from ClinicalTrials.gov

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