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

22 мая 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

300

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Ana S Almeida, PhD
Номер телефона: +351 217999411
Электронная почта: ana.almeida@gimm.pt

Учебное резервное копирование контактов

Имя: Madalena Reis
Номер телефона: +351 217999411
Электронная почта: madalena.reis@gimm.pt

Места учебы

Португалия
- - Lisbon, Португалия
    - Рекрутинг
    - Gulbenkian Institute for Molecular Medicine, Lisbon
    - Контакт:
      
      Ana S Almeida, PhD
      
      Номер телефона: +351 217999411
      
      Электронная почта: ana.almeida@gimm.pt
    - Контакт:
      
      Madalena Reis
      
      Номер телефона: +351 217999411
      
      Электронная почта: madalena.reis@gimm.pt
    - Главный следователь:
      
      Ana S Almeida, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Gut microbiome functional profile. Временное ограничение: 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 Временное ограничение: 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.

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Female sex hormone levels. Временное ограничение: 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. Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Gulbenkian Institute for Molecular Medicine

Соавторы

Biocodex Microbiota Foundation

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

2 июня 2025 г.

Первичное завершение (Оцененный)

1 декабря 2026 г.

Завершение исследования (Оцененный)

1 декабря 2036 г.

Даты регистрации исследования

Первый отправленный

11 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

22 мая 2026 г.

Первый опубликованный (Действительный)

29 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)