Creatine HCl and Creatine Ethyl Ester Supplementation in Perimenopausal and Menopausal Women (CONCRET-MENOPA)

December 15, 2025 updated by: Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • FSPE Applied BIoenergetcis Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Creatine hcl
One capsule per day of creatine hcl during breakfast
Dietary supplement: Dietary Supplement: Experimental 1 Creatine HCl
Creatine hcl
Experimental: Creatine hcl 2
One capsule during breakfast and one during dinner of creatine hcl
Dietary supplement: Dietary Supplement: Experimental 2 Creatine HCl
Creatine hcl
Experimental: Creatine ethyl ester
One capsule during breakfast and one during dinner of creatine ethyl ester
Dietary supplement: Dietary Supplement: Experimental 3 Creatine Ethyl ester
Creatine ethyl ester
Placebo Comparator: Placebo
One capsule per day of inulin during breakfast
Dietary supplement: Dietary Supplement: Experimental 4 Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Change from baseline fatigue at 8 weeks
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
Change from baseline fatigue at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to exhaustion
Time Frame: Change from baseline time to exhaustion at 8 weeks
Running time to exhaustion during incrementaltestontreadmill
Change from baseline time to exhaustion at 8 weeks
Brain creatine
Time Frame: Change from baseline brain creatine concentrations at 8 weeks
Magnetic resonance spectra for brain creatine concentrations
Change from baseline brain creatine concentrations at 8 weeks
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
Change from baseline fatigue at 8 weeks
Amyloid b
Time Frame: Change from baseline time to exhaustion at 8 weeks
Serum levels of amyloid b
Change from baseline time to exhaustion at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Investigators

  • Principal Investigator: Sergej Ostojic, MD, PhD, Applied Bioenergetics Lab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-1-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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