AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Menopause, Gut Microbiome, Hormonal Changes, Chronic Low-Grade Inflammation. Basic parameters: 40 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Gut microbiome functional profile. [Time frame: Baseline and every 2 years over a period of 10 years.]
- Gut microbiome taxonomic composition [Time frame: Baseline and 2 years over a period of 10 years.]
Secondary outcome measures (7)
- Female sex hormone levels. [Time frame: Baseline and every 2 years over a period of 10 years.]
- Inflammation biomarker levels. [Time frame: Baseline and every two years over a period of 10 years.]
- Menopause-related symptoms [Time frame: Baseline and every two years over a period of 10 years.]
- Nutritional data [Time frame: Baseline and every two years over a period of 10 years.]
- Effect of physical activity on gut microbiota composition [Time frame: Baseline and every two years over a period of 10 years.]
- Effect of sleeping habits on gut microbiota composition [Time frame: Baseline and every 2 years over a period of 10 years.]
- Effect of stress levels on gut microbiota composition [Time frame: Baseline and every 2 years over a period of 10 years.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Portugal · 1 center
- Gulbenkian Institute for Molecular Medicine, Lisbon — Lisbon
Identifiers
NCT: NCT07614542 · CAML Ref nº188/25