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

NCT06660004 | Completed

• 1 other identifier: CC-1-24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Menopausal; Perimenopause

Keywords

creatine; brain metabolism; cognition; fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue

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

  Change from baseline fatigue at 8 weeks

Secondary Outcomes (4)

• Time to exhaustion

  Change from baseline time to exhaustion at 8 weeks

• Brain creatine

  Change from baseline brain creatine concentrations at 8 weeks

• Cognitive interference

  Change from baseline fatigue at 8 weeks

• Amyloid b

  Change from baseline time to exhaustion at 8 weeks

Study Arms (4)

Creatine hcl

EXPERIMENTAL

One capsule per day of creatine hcl during breakfast

Dietary Supplement: Dietary Supplement: Experimental 1 Creatine HCl

Creatine hcl 2

EXPERIMENTAL

One capsule during breakfast and one during dinner of creatine hcl

Dietary Supplement: Dietary Supplement: Experimental 2 Creatine HCl

Creatine ethyl ester

EXPERIMENTAL

One capsule during breakfast and one during dinner of creatine ethyl ester

Dietary Supplement: Dietary Supplement: Experimental 3 Creatine Ethyl ester

Placebo

PLACEBO COMPARATOR

One capsule per day of inulin during breakfast

Dietary Supplement: Dietary Supplement: Experimental 4 Placebo

Interventions

Dietary Supplement: Experimental 1 Creatine HCl DIETARY_SUPPLEMENT

Creatine hcl

Creatine hcl

Dietary Supplement: Experimental 2 Creatine HCl DIETARY_SUPPLEMENT

Creatine hcl

Creatine hcl 2

Dietary Supplement: Experimental 3 Creatine Ethyl ester DIETARY_SUPPLEMENT

Creatine ethyl ester

Creatine ethyl ester

Dietary Supplement: Experimental 4 Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (1)

FSPE Applied BIoenergetcis Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (2)

• Ostojic SM, Stea TH, Ellery SJ, Smith-Ryan AE. Association between dietary intake of creatine and female reproductive health: Evidence from NHANES 2017-2020. Food Sci Nutr. 2024 Apr 30;12(7):4893-4898. doi: 10.1002/fsn3.4135. eCollection 2024 Jul.

  PMID: 39055234 BACKGROUND

• Korovljev D, Ostojic J, Panic J, Ranisavljev M, Todorovic N, Nedeljkovic D, Kuzmanovic J, Vranes M, Stajer V, Ostojic SM. The Effects of 8-Week Creatine Hydrochloride and Creatine Ethyl Ester Supplementation on Cognition, Clinical Outcomes, and Brain Creatine Levels in Perimenopausal and Menopausal Women (CONCRET-MENOPA): A Randomized Controlled Trial. J Am Nutr Assoc. 2026 Mar-Apr;45(3):199-210. doi: 10.1080/27697061.2025.2551184. Epub 2025 Aug 25.

  PMID: 40854087 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergej Ostojic, MD, PhD

  Applied BIoenergetics Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the Applied Bioenergetics Lab

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: November 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 31, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.

Locations

SE (1)