Adherence to a creatine-based nutritional supplement in estrogen-depleted women
AssessmenT of thE Adherence of Nutritional Supplementation With Creatine Formula in Estrogen-Depleted Adult Women: Prospective Clinical Investigation
Margan Biotech · NCT07580846
This 12-week observational project will test how well estrogen-depleted women stick to taking a creatine-based nutritional supplement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Female |
| Sponsor | Margan Biotech (industry) |
| Locations | 4 sites (Madrid, Madrid and 3 other locations) |
| Trial ID | NCT07580846 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Biological females aged 40 or older who are estrogen-depleted (natural or surgical menopause or late perimenopause), without major contraindicating comorbidities, willing to take the supplement and follow activity recommendations, and able to attend scheduled visits for 12 weeks.
Not a fit: People with major comorbidities that contraindicate the supplement or recommended physical activity, recent changes in key treatments, or inability/unwillingness to follow dosing and visit requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could show whether this supplement is taken reliably by menopausal women and support its use to help maintain muscle, metabolic, and skin health.
How similar studies have performed: Components like creatine and collagen have shown benefit for muscle and skin in some smaller trials, but adherence-focused, multicenter observational data in estrogen-depleted women are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid, Madrid and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopause, Estrogen Deficiency, Creatine, Women´s Health, Estrogen deficiency, Collagen, Dietary supplements