Actively Recruiting

Age: 40Years - 75Years
FEMALE
Healthy Volunteers
ID07580846

Assessment of Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Adult Women: Prospective Clinical Investigation

Led by Margan Biotech · Updated on 2026-05-12

100

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study to understand how well estrogen-depleted adult women, including those in menopause or late perimenopause, adhere to a creatine-based nutritional supplement called Creaticare FEM. The study aims to describe the percentage of doses consumed and the proportion of women achieving high adherence (80% or more) over 12 weeks. It also looks at persistence, satisfaction, tolerability, and adherence to physical activity recommendations, along with exploratory measures like muscle strength, body composition, quality of life, joint pain, and skin health. Participants will take a daily 10-gram dose of Creaticare FEM, which contains creatine monohydrate, hydrolyzed collagen, hyaluronic acid, beta-alanine, magnesium, and vitamins A, C, E, and B6, for 12 weeks. Alongside supplementation, they receive general physical activity advice consistent with usual clinical care, without supervised exercise or randomization. The study is observational and does not include control groups or experimental interventions beyond routine supplementation. During the 12-week period, women will attend planned visits and complete various assessments, including self-reported adherence to the supplement and physical activity, adverse event monitoring, and questionnaires on satisfaction. Exploratory assessments will measure changes in muscle strength, body composition, quality of life, joint pain, and skin health. The study seeks to provide real-world information on how well this nutritional supplement is accepted and tolerated in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 75Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Biological female sex.
  • Age 40 years or older.
  • Estrogen-depleted status, including natural menopause (no menstrual periods for 12 months), surgically induced menopause, or late perimenopause with elevated FSH.
  • No major health problems that prevent use of the supplement or physical activity.
  • No significant changes in usual treatments in the past 3 months.
  • Ability to understand study information and provide written consent.
  • Willingness to take the supplement as instructed.
  • Willingness to follow general physical activity recommendations.
  • Willingness and ability to attend visits and complete assessments through 12 weeks.
Not Eligible

You will not qualify if you...

  • Starting or changing treatment with GLP-1 receptor agonists in the last 12 weeks.
  • Musculoskeletal or joint conditions that limit regular physical activity or study assessments.
  • Significant kidney or liver disease.
  • Current use of diuretics or medications harmful to kidneys.
  • Known allergy or intolerance to any supplement ingredient.
  • Participation in another clinical study in the last 3 months.
  • Any medical or social condition that could interfere with participation, adherence, or data validity.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 12 weeks

Participants take a daily creatine-based nutritional supplement for 12 weeks and follow general physical activity recommendations as part of routine care. Adherence, acceptability, and tolerability of the supplementation are observed during this period.

Visits as needed for assessments during the 12-week supplementation period

Trial Site Locations

Total: 4 locations

1

Clínica Palacios

Madrid, Madrid, Spain, 28034

Actively Recruiting

2

Menoclinica by Palacios

Madrid, Madrid, Spain, 28034

Actively Recruiting

3

Ginegetafe

Madrid, Madrid, Spain, 28901

Actively Recruiting

4

Clinica Palacios Málaga

Málaga, Málaga, Spain, 29016

Not Yet Recruiting

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Research Team

S

Silvia Martinez

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Nutritional Strategies for Optimizing Health, Sports Performance, and Recovery for Female Athletes and Other Physically Active Women: A Systematic Review.

Mar Larrosa, Angel Gil-Izquierdo, Liliana Guadalupe González-Rodríguez...

https://pubmed.ncbi.nlm.nih.gov/38994896

β-alanine supplementation to improve exercise capacity and performance: a systematic review and meta-analysis.

Bryan Saunders, Kirsty Elliott-Sale, Guilherme G Artioli...

https://pubmed.ncbi.nlm.nih.gov/27797728

A High Dose of Creatine Combined with Resistance Training Appears to Be Required to Augment Indices of Bone Health in Older Adults.

Scott C Forbes, Sergej M Ostojic, Tacito P Souza-Junior...

https://pubmed.ncbi.nlm.nih.gov/34788768