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AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing

22 de mayo de 2026 actualizado por: Gulbenkian Institute for Molecular Medicine
AGEWISE is an observational study that aims to understand how changes in gut microbiome are related to hormonal changes during women's ageing, particularly across the different stages of menopause. The study will include healthy women aged 40 to 64 years living in Portugal, who will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. Researchers will study the gut microbiome together with hormone levels and markers of inflammation to better understand how menopause affects long-term health and to support the development of improved prevention strategies for women.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

AGEWISE aims to investigate the relationship between the gut microbiome, female sex hormones, chronic low-grade inflammation, and women's ageing across the menopausal transition.

The results will support the identification of microbiome-based and blood-based biomarkers associated with menopause and ageing, and contribute to the development of data-driven tools for personalised risk assessment and prevention strategies in women's health.

Primary Objective:

To identify and validate faecal microbiome biomarkers by analysing taxonomic and functional changes across different stages of menopause in women.

Secondary Objectives:

To explore associations between gut microbiome composition and female sex hormone levels, including estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), anti-Müllerian hormone (AMH), and cortisol.

To investigate the relationship between the gut microbiome and blood biomarkers of chronic low-grade inflammation (inflammaging).

To assess associations between microbiome profiles, clinical history, lifestyle, and dietary factors and the risk of conditions associated with menopause.

Tipo de estudio

De observación

Inscripción (Estimado)

300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ana S Almeida, PhD
  • Número de teléfono: +351 217999411
  • Correo electrónico: ana.almeida@gimm.pt

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Portugal
      • Lisbon, Portugal
        • Reclutamiento
        • Gulbenkian Institute for Molecular Medicine, Lisbon
        • Contacto:
          • Ana S Almeida, PhD
          • Número de teléfono: +351 217999411
          • Correo electrónico: ana.almeida@gimm.pt
        • Contacto:
        • Investigador principal:
          • Ana S Almeida, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Participants are recruited using non-random, voluntary recruitment strategies. Eligible women are identified through open public calls, institutional outreach activities, existing biobank donor databases, and re-contact of participants from related research projects who have previously agreed to be contacted for future studies. Enrollment is based on predefined eligibility criteria and the individual's willingness to participate. All potential participants who meet the eligibility criteria receive detailed information about the study from the research team, and those who agree to take part are required to provide written informed consent prior to participation.

Descripción

Inclusion Criteria:

  • Female sex
  • Aged 40 to 64 years
  • Resident in mainland Portugal or the islands
  • Able and willing to provide written informed consent
  • Willing to provide stool and blood samples and complete three questionnaires

Exclusion Criteria:

  • Age below 40 years or 65 years and older
  • Inability to give informed consent
  • Refusal to provide stool or blood samples or complete questionnaires
  • Pregnancy
  • Diagnosed gastrointestinal disorders (including inflammatory bowel disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic diarrhoea of unknown cause, or recurrent Clostridioides difficile infection)
  • Active oncological disease

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Premenopausal women (self-reported)
Regular menstrual periods, with no signs of menopause yet.
Perimenopausal women (self-reported)
Irregular menstrual periods, presence of some menopausal symptoms, such as hot flashes, mood changes, sleep disturbances, and brain fog.
Menopausal/Postmenopausal women (self-reported)
Absence of menstruation for 12 consecutive months.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gut microbiome functional profile.
Periodo de tiempo: Baseline and every 2 years over a period of 10 years.
Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.
Baseline and every 2 years over a period of 10 years.
Gut microbiome taxonomic composition
Periodo de tiempo: Baseline and 2 years over a period of 10 years.
Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.
Baseline and 2 years over a period of 10 years.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Female sex hormone levels.
Periodo de tiempo: Baseline and every 2 years over a period of 10 years.
Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
Baseline and every 2 years over a period of 10 years.
Inflammation biomarker levels.
Periodo de tiempo: Baseline and every two years over a period of 10 years.
Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
Baseline and every two years over a period of 10 years.
Menopause-related symptoms
Periodo de tiempo: Baseline and every two years over a period of 10 years.
Self-reported menopausal symptoms will be assessed via online questionnaires that include reproductive, medical history and associated symptoms.
Baseline and every two years over a period of 10 years.
Nutritional data
Periodo de tiempo: Baseline and every two years over a period of 10 years.
Self-reported dietary intake will be assessed via telephone interview through two 24-hour recalls, following protocols validated by the Portuguese National Food and Physical Activity Survey (IAN-AF).
Baseline and every two years over a period of 10 years.
Effect of physical activity on gut microbiota composition
Periodo de tiempo: Baseline and every two years over a period of 10 years.
Physical activity will be assessed using International Physical Activity Questionnaire - Short Form a validated tool composed of 7 questions covering the last 7 days of physical activity across three intensity levels which allows classification of participants into three activity levels: low, moderate, or high.
Baseline and every two years over a period of 10 years.
Effect of sleeping habits on gut microbiota composition
Periodo de tiempo: Baseline and every 2 years over a period of 10 years.
Sleeping habits will be assessed by the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that consists of 19 items which are distributed into seven "components": subjective sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbances; use of sleeping medication; day-time dysfunction. Each component is scored from 0 to 2, and the sum of the component scores yields a global PSQI score. A global PSQI score ≥6 will indicate poor sleep quality.
Baseline and every 2 years over a period of 10 years.
Effect of stress levels on gut microbiota composition
Periodo de tiempo: Baseline and every 2 years over a period of 10 years.
Stress levels will be assessed by the Perceived Stress Scale, a validated questionnaire composed of 10 questions. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 will be considered low stress, 14-26 will be considered moderate stress and scores ranging from 27-40 will be considered high perceived stress.
Baseline and every 2 years over a period of 10 years.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Gulbenkian Institute for Molecular Medicine

Colaboradores

Biocodex Microbiota Foundation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de junio de 2025

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2036

Fechas de registro del estudio

Enviado por primera vez

11 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • CAML Ref nº188/25

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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