CONCRET-MENOPACreatine Supplements for Cognitive Performance in Menopausal Women
Dietary Supplement: Experimental 1 Creatine HCl
+ Dietary Supplement: Experimental 2 Creatine HCl
+ Dietary Supplement: Experimental 3 Creatine Ethyl ester
Fatigue
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
Supportive Care Study
Summary
Study start date: November 15, 2024
Actual date on which the first participant was enrolled.This study is designed to explore how supplements like creatine HCl and creatine ethyl ester can affect the brain and body functions of women who are going through or have completed menopause. The research focuses on understanding changes in mental capabilities, levels of tiredness, brain health, and certain biochemical markers. Such studies are important because women in this stage of life often experience changes in these areas, and finding effective supplements could improve their quality of life. Participants in the study will receive either creatine HCl or creatine ethyl ester supplements. These supplements are administered in a controlled manner, ensuring neither the participants nor the researchers know who is receiving which type. The effects on cognitive abilities, fatigue, brain metabolism, and biochemical markers will be closely monitored and evaluated. This approach helps ensure that any observed changes are due to the supplements and not other factors, aiming to provide clear insights into the potential benefits or risks of these dietary additions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 40 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location