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

Sponsor
Margan Biotech
Study ID
NCT07580846
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
Mar 20, 2026
Status verified
May 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Creatine-based nutritional supplement
    Single prospective cohort of estrogen-depleted adult women (menopause or late perimenopause) receiving a creatine-based nutritional supplement for 12 weeks under routine clinical practice conditions. Participants take a daily dose of the supplement (10 g), which contains creatine monohydrate, hydrolyzed collagen, hyaluronic acid, beta-alanine, magnesium, and vitamins A, C, E, and B6. In addition, participants receive general recommendations for physical activity (including strength and aerobic exercise) consistent with standard clinical advice, without supervised training or structured intervention. The study does not include randomization, control group, or experimental assignment, as it aims to evaluate adherence, acceptability, and tolerability of nutritional supplementation in a real-world setting.

Primary Outcome Measure

Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence [ Time Frame: 12 weeks ]

Central Contacts

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