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

2026年5月5日 更新者：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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 西班牙
    • Madrid
      • Madrid、Madrid、西班牙、28034
        • 招聘中
        • Clínica Palacios
        • 接触：
        • 首席研究员：
          • Santiago Palacios, Doctor
        • 副研究员：
          • Raquel Miguel, Doctor
      • Madrid、Madrid、西班牙、28034
        • 招聘中
        • Menoclinica by Palacios
        • 接触：
        • 首席研究员：
          • Silvia P Gonzalez, Doctor
        • 副研究员：
          • Esmeralda Josa, Nutritionist
      • Madrid、Madrid、西班牙、28901
        • 招聘中
        • Ginegetafe
        • 接触：
        • 首席研究员：
          • Carmen Pingarron, Doctor
        • 首席研究员：
          • Silvia Poyo, Doctor
    • Málaga
      • Málaga、Málaga、西班牙、29016
        • 尚未招聘
        • Clinica Palacios Málaga
        • 接触：
        • 首席研究员：
          • Rodrigo Orozco, Doctor

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Proportion of Participants Persisting with Supplementation at Week 12
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in Handgrip Strength Measured by Dynamometry (kg)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Margan Biotech

调查人员

  • 研究主任：Silvia P Gonzalez, Doctor、Menoclinica by Palacios

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月20日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2026年10月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ATENEA

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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