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

NCT07580846 | Recruiting

• 1 other identifier: ATENEA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Menopause; Estrogen Deficiency

Keywords

Creatine; Menopause; Women´s Health; Estrogen deficiency; Collagen; Dietary supplements

Outcome Measures

Primary Outcomes (1)

• Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence

  Adherence to supplementation assessed as the percentage of prescribed doses consumed during the 12-week study period, based on participant self-reported daily supplementation logs. Adherence will be expressed as a continuous variable (0-100%). In addition, the proportion of participants achieving ≥80% adherence at Week 12 will be calculated. Higher values indicate greater adherence.

  12 weeks

Secondary Outcomes (4)

• Proportion of Participants Persisting with Supplementation at Week 12

  12 weeks

• Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question)

  12 weeks

• Number of Participants With Adverse Events Related or Unrelated to Supplementation

  12 weeks

• Adherence to Recommended Physical Activity (Daily Self-Reported Exercise Log)

  12 weeks

Other Outcomes (5)

• Change in Handgrip Strength Measured by Dynamometry (kg)

  Baseline to Week 12

• Change in Joint Pain Measured by Visual Analog Scale (VAS, 0-10)

  Baseline to Week 12

• Change in Body Composition Measured by Bioimpedance Analysis (Lean Mass, Fat Mass, Total Body Water, Protein, Skeletal Muscle Mass)

  Baseline to Week 12

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Estrogen-depleted adult women (menopause or late perimenopause) attending routine clinical practice consultations in participating centers and initiating nutritional supplementation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Margan Biotech: lead

Study Sites (4)

Clínica Palacios

Madrid, Madrid, 28034, Spain

RECRUITING

Menoclinica by Palacios

Madrid, Madrid, 28034, Spain

RECRUITING

Ginegetafe

Madrid, Madrid, 28901, Spain

RECRUITING

Clinica Palacios Málaga

Málaga, Málaga, 29016, Spain

NOT YET RECRUITING

Related Publications (18)

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• Bakian AV, Huber RS, Scholl L, Renshaw PF, Kondo D. Dietary creatine intake and depression risk among U.S. adults. Transl Psychiatry. 2020 Feb 3;10(1):52. doi: 10.1038/s41398-020-0741-x.

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• Allen PJ. Creatine metabolism and psychiatric disorders: Does creatine supplementation have therapeutic value? Neurosci Biobehav Rev. 2012 May;36(5):1442-62. doi: 10.1016/j.neubiorev.2012.03.005. Epub 2012 Mar 24.

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Related Links

• EFSA statement Beta-alanine
• AESAN statement Creatine
• Magnesium bisglicinate NIH

Study Officials

• Silvia P Gonzalez, Doctor

  Menoclinica by Palacios

  STUDY DIRECTOR

Central Study Contacts

Silvia Martinez

CONTACT

+34606441146; silvia.martinez@marganbiotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)