RecruitingNCT07580846

ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women

AssessmenT of thE Adherence of Nutritional Supplementation With Creatine Formula in Estrogen-Depleted Adult Women: Prospective Clinical Investigation

Sponsor

Margan Biotech

Enrollment

100 participants

Start Date

Mar 20, 2026

Study Type

OBSERVATIONAL

Conditions

Menopause Estrogen Deficiency

Summary

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

Sex: FEMALEMin Age: 40 YearsMax Age: 75 Years

Inclusion Criteria10

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 Criteria7

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.