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

University of Novi Sad, Faculty of Sport and Physical Education

Status: Invitation-only

Conditions: Menopausal; Perimenopause

Treatments: Dietary Supplement: Dietary Supplement: Experimental 3 Creatine Ethyl ester; Dietary Supplement: Dietary Supplement: Experimental 1 Creatine HCl; Dietary Supplement: Dietary Supplement: Experimental 2 Creatine HCl; Dietary Supplement: Dietary Supplement: Experimental 4 Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06660004

CC-1-24

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

Creatine hcl

Experimental group

Description:

One capsule per day of creatine hcl during breakfast

Treatment:

Dietary Supplement: Dietary Supplement: Experimental 1 Creatine HCl

Creatine hcl 2

Experimental group

Description:

One capsule during breakfast and one during dinner of creatine hcl

Treatment:

Dietary Supplement: Dietary Supplement: Experimental 2 Creatine HCl

Creatine ethyl ester

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Supplement: Experimental 3 Creatine Ethyl ester

Placebo

Placebo Comparator group

Description:

One capsule per day of inulin during breakfast

Treatment:

Dietary Supplement: Dietary Supplement: Experimental 4 Placebo