Adherence to a creatine-based nutritional supplement in estrogen-depleted women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational study follows estrogen-depleted adult women under routine clinical practice to describe adherence to a daily creatine-based nutritional supplement (Creaticare FEM) over 12 weeks. The supplement contains creatine monohydrate, hydrolyzed collagen, hyaluronic acid, beta-alanine, magnesium, and vitamins at a 10 g daily dose. The primary outcome is adherence measured as percentage of doses consumed and the proportion of participants achieving ≥80% adherence, with secondary outcomes including persistence, satisfaction, tolerability, and adherence to recommended physical activity. Exploratory analyses will report pre-post changes in muscle strength, body composition, quality of life, joint pain, and skin health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biological female sex.
* Age ≥40 years.
* Estrogen-depleted status, defined as at least one of the following:

natural menopause, defined as amenorrhea for ≥12 consecutive months; surgically induced menopause; late perimenopause with elevated FSH according to clinical judgment.

* Absence of major comorbidities that would contraindicate use of the nutritional supplement or the recommended physical activity.
* No relevant changes in usual treatment during the previous 3 months.
* Ability to understand the study information and provide written informed consent.
* Willingness to take the nutritional supplement according to the study instructions.
* Willingness to follow general physical activity recommendations provided by the investigator.
* Willingness and ability to attend the planned visits and complete study assessments through Week 12.

Exclusion Criteria:

* Initiation or modification of treatment with GLP-1 receptor agonists within the previous 12 weeks.
* Presence of musculoskeletal or joint conditions that significantly limit the ability to perform regular physical activity or study-related functional assessments.
* Clinically relevant renal or hepatic disease.
* Current use of diuretics or potentially nephrotoxic medications.
* Known allergy or intolerance to any component of the nutritional supplement.
* Participation in another clinical study (nutritional, pharmacological, or interventional) within the previous 3 months.
* Any medical condition or social circumstance that, in the investigator's judgment, could interfere with study participation, adherence, or data validity.

Where it's running

• Clínica Palacios
  Madrid, Madrid, Spain Recruiting
• Menoclinica by Palacios
  Madrid, Madrid, Spain Recruiting
• Ginegetafe
  Madrid, Madrid, Spain Recruiting
• Clinica Palacios Málaga
  Málaga, Málaga, Spain Not yet recruiting

Study contacts

• Study coordinator: Silvia Martinez
• Email: silvia.martinez@marganbiotech.com
• Phone: +34606441146

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.