AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
22. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
300
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Ana S Almeida, PhD
- Telefonnummer: +351 217999411
- E-Mail: ana.almeida@gimm.pt
Studieren Sie die Kontaktsicherung
- Name: Madalena Reis
- Telefonnummer: +351 217999411
- E-Mail: madalena.reis@gimm.pt
Studienorte
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Lisbon, Portugal
- Rekrutierung
- Gulbenkian Institute for Molecular Medicine, Lisbon
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Kontakt:
- Ana S Almeida, PhD
- Telefonnummer: +351 217999411
- E-Mail: ana.almeida@gimm.pt
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Kontakt:
- Madalena Reis
- Telefonnummer: +351 217999411
- E-Mail: madalena.reis@gimm.pt
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Hauptermittler:
- Ana S Almeida, PhD
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gut microbiome functional profile.
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Female sex hormone levels.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
2. Juni 2025
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Dezember 2036
Studienanmeldedaten
Zuerst eingereicht
11. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Mai 2026
Zuerst gepostet (Tatsächlich)
29. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CAML Ref nº188/25
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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