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

22. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Ana S Almeida, PhD
Telefonnummer: +351 217999411
E-post: ana.almeida@gimm.pt

Studer Kontakt Backup

Navn: Madalena Reis
Telefonnummer: +351 217999411
E-post: madalena.reis@gimm.pt

Studiesteder

Portugal
- - Lisbon, Portugal
    - Rekruttering
    - Gulbenkian Institute for Molecular Medicine, Lisbon
    - Ta kontakt med:
      
      Ana S Almeida, PhD
      
      Telefonnummer: +351 217999411
      
      E-post: ana.almeida@gimm.pt
    - Ta kontakt med:
      
      Madalena Reis
      
      Telefonnummer: +351 217999411
      
      E-post: madalena.reis@gimm.pt
    - Hovedetterforsker:
      
      Ana S Almeida, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Gut microbiome functional profile. Tidsramme: 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 Tidsramme: 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.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Female sex hormone levels. Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gulbenkian Institute for Molecular Medicine

Samarbeidspartnere

Biocodex Microbiota Foundation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. juni 2025

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2036

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)