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

5 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Hiszpania
    • Madrid
      • Madrid, Madrid, Hiszpania, 28034
        • Rekrutacyjny
        • Clínica Palacios
        • Kontakt:
        • Główny śledczy:
          • Santiago Palacios, Doctor
        • Pod-śledczy:
          • Raquel Miguel, Doctor
      • Madrid, Madrid, Hiszpania, 28034
        • Rekrutacyjny
        • Menoclinica by Palacios
        • Kontakt:
        • Główny śledczy:
          • Silvia P Gonzalez, Doctor
        • Pod-śledczy:
          • Esmeralda Josa, Nutritionist
      • Madrid, Madrid, Hiszpania, 28901
        • Rekrutacyjny
        • Ginegetafe
        • Kontakt:
        • Główny śledczy:
          • Carmen Pingarron, Doctor
        • Główny śledczy:
          • Silvia Poyo, Doctor
    • Málaga
      • Málaga, Málaga, Hiszpania, 29016
        • Jeszcze nie rekrutacja
        • Clinica Palacios Málaga
        • Kontakt:
        • Główny śledczy:
          • Rodrigo Orozco, Doctor

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Participants Persisting with Supplementation at Week 12
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in Handgrip Strength Measured by Dynamometry (kg)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Margan Biotech

Śledczy

  • Dyrektor Studium: Silvia P Gonzalez, Doctor, Menoclinica by Palacios

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 marca 2026

Zakończenie podstawowe (Szacowany)

1 października 2026

Ukończenie studiów (Szacowany)

1 października 2026

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2026

Pierwszy wysłany (Rzeczywisty)

12 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • ATENEA

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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