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

22 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

300

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Ana S Almeida, PhD
Numer telefonu: +351 217999411
E-mail: ana.almeida@gimm.pt

Kopia zapasowa kontaktu do badania

Nazwa: Madalena Reis
Numer telefonu: +351 217999411
E-mail: madalena.reis@gimm.pt

Lokalizacje studiów

Portugalia
- - Lisbon, Portugalia
    - Rekrutacyjny
    - Gulbenkian Institute for Molecular Medicine, Lisbon
    - Kontakt:
      
      Ana S Almeida, PhD
      
      Numer telefonu: +351 217999411
      
      E-mail: ana.almeida@gimm.pt
    - Kontakt:
      
      Madalena Reis
      
      Numer telefonu: +351 217999411
      
      E-mail: madalena.reis@gimm.pt
    - Główny śledczy:
      
      Ana S Almeida, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Gut microbiome functional profile. Ramy czasowe: 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 Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Female sex hormone levels. Ramy czasowe: 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. Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gulbenkian Institute for Molecular Medicine

Współpracownicy

Biocodex Microbiota Foundation

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 czerwca 2025

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 grudnia 2036

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)