AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
22. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ana S Almeida, PhD
- Telefonnummer: +351 217999411
- E-mail: ana.almeida@gimm.pt
Undersøgelse Kontakt Backup
- Navn: Madalena Reis
- Telefonnummer: +351 217999411
- E-mail: madalena.reis@gimm.pt
Studiesteder
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Lisbon, Portugal
- Rekruttering
- Gulbenkian Institute for Molecular Medicine, Lisbon
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Kontakt:
- Ana S Almeida, PhD
- Telefonnummer: +351 217999411
- E-mail: ana.almeida@gimm.pt
-
Kontakt:
- Madalena Reis
- Telefonnummer: +351 217999411
- E-mail: madalena.reis@gimm.pt
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Ledende efterforsker:
- Ana S Almeida, PhD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Premenopausal women (self-reported)
Regular menstrual periods, with no signs of menopause yet.
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Perimenopausal women (self-reported)
Irregular menstrual periods, presence of some menopausal symptoms, such as hot flashes, mood changes, sleep disturbances, and brain fog.
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Menopausal/Postmenopausal women (self-reported)
Absence of menstruation for 12 consecutive months.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gut microbiome functional profile.
Tidsramme: Baseline and every 2 years over a period of 10 years.
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Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.
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Baseline and every 2 years over a period of 10 years.
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Gut microbiome taxonomic composition
Tidsramme: Baseline and 2 years over a period of 10 years.
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Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.
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Baseline and 2 years over a period of 10 years.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Female sex hormone levels.
Tidsramme: Baseline and every 2 years over a period of 10 years.
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Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
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Baseline and every 2 years over a period of 10 years.
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Inflammation biomarker levels.
Tidsramme: Baseline and every two years over a period of 10 years.
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Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
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Baseline and every two years over a period of 10 years.
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Menopause-related symptoms
Tidsramme: Baseline and every two years over a period of 10 years.
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Self-reported menopausal symptoms will be assessed via online questionnaires that include reproductive, medical history and associated symptoms.
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Baseline and every two years over a period of 10 years.
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Nutritional data
Tidsramme: Baseline and every two years over a period of 10 years.
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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).
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Baseline and every two years over a period of 10 years.
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Effect of physical activity on gut microbiota composition
Tidsramme: Baseline and every two years over a period of 10 years.
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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.
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Baseline and every two years over a period of 10 years.
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Effect of sleeping habits on gut microbiota composition
Tidsramme: Baseline and every 2 years over a period of 10 years.
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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.
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Baseline and every 2 years over a period of 10 years.
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Effect of stress levels on gut microbiota composition
Tidsramme: Baseline and every 2 years over a period of 10 years.
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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.
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Baseline and every 2 years over a period of 10 years.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. juni 2025
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2036
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
22. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CAML Ref nº188/25
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