AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
22 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
300
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ana S Almeida, PhD
- Numero di telefono: +351 217999411
- Email: ana.almeida@gimm.pt
Backup dei contatti dello studio
- Nome: Madalena Reis
- Numero di telefono: +351 217999411
- Email: madalena.reis@gimm.pt
Luoghi di studio
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Lisbon, Portogallo
- Reclutamento
- Gulbenkian Institute for Molecular Medicine, Lisbon
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Contatto:
- Ana S Almeida, PhD
- Numero di telefono: +351 217999411
- Email: ana.almeida@gimm.pt
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Contatto:
- Madalena Reis
- Numero di telefono: +351 217999411
- Email: madalena.reis@gimm.pt
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Investigatore principale:
- Ana S Almeida, PhD
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Gut microbiome functional profile.
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Female sex hormone levels.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 giugno 2025
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
1 dicembre 2036
Date di iscrizione allo studio
Primo inviato
11 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 maggio 2026
Primo Inserito (Effettivo)
29 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CAML Ref nº188/25
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .