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

5 de maio de 2026 atualizado por: Margan Biotech

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

This is a prospective, multicenter, observational clinical study aimed at evaluating adherence to a creatine-based nutritional supplementation (Creaticare FEM) in estrogen-depleted adult women, including those in menopause or late perimenopause.

Creaticare FEM is a multi-ingredient dietary supplement formulated to support musculoskeletal, metabolic, and skin health in this population. The daily dose (10 g) contains creatine monohydrate (3 g), hydrolyzed collagen (5 g), hyaluronic acid (95 mg), beta-alanine (300 mg), magnesium (200 mg), and vitamins A, C, E, and B6.

Participants will receive the nutritional supplement for a period of 12 weeks, without any modification of standard clinical practice. The primary objective is to describe adherence to supplementation, defined as the percentage of prescribed doses consumed during the study period and the proportion of participants achieving high adherence (≥80%) at the end of follow-up.

Secondary objectives include the assessment of persistence with supplementation, participant-reported acceptability and satisfaction, tolerability through the monitoring of adverse events, and adherence to a general recommendation of physical activity provided as part of routine care.

In addition, exploratory analyses will be performed to describe pre-post changes over the 12-week period in selected clinical variables, including muscle strength (handgrip dynamometry), body composition (bioimpedance), quality of life (Cervantes questionnaire), joint pain (visual analog scale), and skin health perception (cosmetic VAS). These exploratory outcomes are descriptive in nature and intended to generate hypotheses for future controlled studies.

The study does not involve randomization, control group, or experimental intervention beyond routine supplementation, and therefore is not intended to establish causal relationships or confirm clinical efficacy, but rather to provide real-world evidence on adherence, acceptability, and tolerability of a multimodal nutritional supplement in this population.

Tipo de estudo

Observacional

Inscrição (Estimado)

100

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Espanha
    • Madrid
      • Madrid, Madrid, Espanha, 28034
        • Recrutamento
        • Clínica Palacios
        • Contato:
        • Investigador principal:
          • Santiago Palacios, Doctor
        • Subinvestigador:
          • Raquel Miguel, Doctor
      • Madrid, Madrid, Espanha, 28034
        • Recrutamento
        • Menoclinica by Palacios
        • Contato:
        • Investigador principal:
          • Silvia P Gonzalez, Doctor
        • Subinvestigador:
          • Esmeralda Josa, Nutritionist
      • Madrid, Madrid, Espanha, 28901
        • Recrutamento
        • Ginegetafe
        • Contato:
        • Investigador principal:
          • Carmen Pingarron, Doctor
        • Investigador principal:
          • Silvia Poyo, Doctor
    • Málaga
      • Málaga, Málaga, Espanha, 29016
        • Ainda não está recrutando
        • Clinica Palacios Málaga
        • Contato:
        • Investigador principal:
          • Rodrigo Orozco, Doctor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence
Prazo: 12 weeks

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants Persisting with Supplementation at Week 12
Prazo: 12 weeks
Persistence with supplementation defined as the proportion of participants who continue taking the supplement until the end of the study period (Week 12). Results will be expressed as the percentage of participants who remain on supplementation. Reasons for discontinuation will be recorded and summarized descriptively.
12 weeks
Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question)
Prazo: 12 weeks
Participant-reported satisfaction assessed using a numeric rating scale from 0 to 10, where 0 indicates no satisfaction and 10 indicates maximum satisfaction. Willingness to continue supplementation is assessed using a binary (yes/no) question. Summary measures will include mean satisfaction scores and the proportion of participants willing to continue supplementation.
12 weeks
Number of Participants With Adverse Events Related or Unrelated to Supplementation
Prazo: 12 weeks
Number of participants reporting adverse events during the 12-week study period, including the type of event, severity, and investigator-assessed relationship to supplementation. Adverse events will be summarized by frequency and percentage of participants affected.
12 weeks
Adherence to Recommended Physical Activity (Daily Self-Reported Exercise Log)
Prazo: 12 weeks
Adherence to recommended physical activity assessed using a study-specific daily self-reported exercise log, in which participants record the performance (yes/no) of strength exercise (30 minutes), aerobic exercise (30 minutes), and stretching (5 minutes) on a daily basis. Adherence will be calculated as the proportion of days in which recommended activities are performed over the study period (0-100%), where higher values indicate greater adherence to physical activity recommendations.
12 weeks

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in Handgrip Strength Measured by Dynamometry (kg)
Prazo: Baseline to Week 12
Change in handgrip strength measured using a hand dynamometer (kg) between baseline and Week 12. Three consecutive measurements will be performed on the same hand, and the mean value (kg) will be calculated for each participant. Higher values indicate greater muscle strength.
Baseline to Week 12
Change in Joint Pain Measured by Visual Analog Scale (VAS, 0-10)
Prazo: Baseline to Week 12
Change in perceived joint pain measured using a Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates worst possible pain, between baseline and Week 12. Higher scores indicate greater pain.
Baseline to Week 12
Change in Body Composition Measured by Bioimpedance Analysis (Lean Mass, Fat Mass, Total Body Water, Protein, Skeletal Muscle Mass)
Prazo: Baseline to Week 12
Change in body composition parameters assessed by bioimpedance analysis between baseline and Week 12, including lean mass (kg), fat mass (kg), total body water (%), protein mass (kg), and skeletal muscle mass (kg). Changes in these parameters will be analyzed descriptively, with higher lean mass, protein mass, skeletal muscle mass, and total body water, and lower fat mass, indicating improved body composition.
Baseline to Week 12
Change Cervantes Scale of Health-Related Quality of Life total score (0-40) and by domains
Prazo: Baseline to Week 12

Change in quality of life assessed using the Cervantes Scale, a validated 31-item questionnaire specific for menopausal women. The questionnaire includes the following domains: menopause and health, psychological domain, sexuality, couple relationship, and vasomotor symptoms. Domain-specific scores and total score will be analyzed descriptively.

Questionnaires with 3 or more missing items will be considered invalid; questionnaires with 1 or 2 missing items will be handled according to the correction rules specified in the instrument manual.
Baseline to Week 12
Change in Skin Health Perception Measured by Visual Analog Scale (VAS, 0-10)
Prazo: Baseline to Week 12

Change in perceived skin health assessed using a Visual Analog Scale (VAS; 0-10) evaluating multiple domains, including skin hydration and comfort, luminosity and overall appearance, anti-aging perception, and overall perceived efficacy.

Each domain is scored from 0 to 10, where 0 indicates the worst perception and 10 indicates the best perception. Higher scores indicate better perceived skin health. Summary measures will include mean scores for each domain.
Baseline to Week 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Margan Biotech

Investigadores

  • Diretor de estudo: Silvia P Gonzalez, Doctor, Menoclinica by Palacios

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de março de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de maio de 2026

Primeira postagem (Real)

12 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • ATENEA

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

The study was not designed with a formal data-sharing plan, and appropriate governance mechanisms for external data access have not been established.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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