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Completed

NCT Number: NCT06660004

Creatine HCl and Creatine Ethyl Ester Supplementation 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

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Key information

Conditions

Menopausal Fatigue Pathological Conditions, Signs and Symptoms Perimenopause Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

FSPE Applied BIoenergetcis Lab

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Supplement: Experimental 1 Creatine HCl

Dietary Supplement

Creatine hcl

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

Primary outcomes

  1. Fatigue

    Time frame: Change from baseline fatigue at 8 weeks

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

Secondary outcomes

  1. Time to exhaustion

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

    Running time to exhaustion during incrementaltestontreadmill

  2. Brain creatine

    Time frame: Change from baseline brain creatine concentrations at 8 weeks

    Magnetic resonance spectra for brain creatine concentrations

  3. Cognitive interference

    Time frame: Change from baseline fatigue at 8 weeks

    Ability to inhibit cognitive interference as assessed by the The Stroop Color and Word Test

  4. Amyloid b

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

    Serum levels of amyloid b

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study 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

Acronym: CONCRET-MENOPA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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