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

22 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

300

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Ana S Almeida, PhD
Telefoonnummer: +351 217999411
E-mail: ana.almeida@gimm.pt

Studie Contact Back-up

Naam: Madalena Reis
Telefoonnummer: +351 217999411
E-mail: madalena.reis@gimm.pt

Studie Locaties

Portugal
- - Lisbon, Portugal
    - Werving
    - Gulbenkian Institute for Molecular Medicine, Lisbon
    - Contact:
      
      Ana S Almeida, PhD
      
      Telefoonnummer: +351 217999411
      
      E-mail: ana.almeida@gimm.pt
    - Contact:
      
      Madalena Reis
      
      Telefoonnummer: +351 217999411
      
      E-mail: madalena.reis@gimm.pt
    - Hoofdonderzoeker:
      
      Ana S Almeida, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Gut microbiome functional profile. Tijdsspanne: 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 Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Female sex hormone levels. Tijdsspanne: 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. Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gulbenkian Institute for Molecular Medicine

Medewerkers

Biocodex Microbiota Foundation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juni 2025

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2036

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)