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

Not Applicable

• Conditions: Menopausal; Perimenopause

• Registration Number: NCT06660004
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Study Start: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue	Change from baseline fatigue at 8 weeks	Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

FSPE Applied BIoenergetcis Lab; 🇷🇸 Novi Sad, Vojvodina, Serbia