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

22 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

300

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Ana S Almeida, PhD
Numéro de téléphone: +351 217999411
E-mail: ana.almeida@gimm.pt

Sauvegarde des contacts de l'étude

Nom: Madalena Reis
Numéro de téléphone: +351 217999411
E-mail: madalena.reis@gimm.pt

Lieux d'étude

Le Portugal
- - Lisbon, Le Portugal
    - Recrutement
    - Gulbenkian Institute for Molecular Medicine, Lisbon
    - Contact:
      
      Ana S Almeida, PhD
      
      Numéro de téléphone: +351 217999411
      
      E-mail: ana.almeida@gimm.pt
    - Contact:
      
      Madalena Reis
      
      Numéro de téléphone: +351 217999411
      
      E-mail: madalena.reis@gimm.pt
    - Chercheur principal:
      
      Ana S Almeida, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Gut microbiome functional profile. Délai: 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 Délai: 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.

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Female sex hormone levels. Délai: 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. Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gulbenkian Institute for Molecular Medicine

Collaborateurs

Biocodex Microbiota Foundation

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2025

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2036

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

22 mai 2026

Première publication (Réel)

29 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)