ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-75
SponsorMargan Biotech
About this trial
This is a prospective, multicenter, observational clinical study conducted under routine clinical practice conditions aimed at describing adherence to a creatine-based nutritional supplement (Creaticare FEM) in estrogen-depleted adult women. Participants will receive the supplement for 12 weeks, and adherence will be assessed as the percentage of doses consumed and the proportion of participants achieving ≥80% adherence. Secondary outcomes include persistence, satisfaction, tolerability, and adherence to recommended physical activity. Exploratory outcomes include changes in muscle strength, body composition, quality of life, joint pain, and skin health.
Eligibility criteria
Qualifiers
Biological female sex.
Age ≥40 years.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
100 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov