AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Menopause, Gut Microbiome, Hormonal Changes, Chronic Low-Grade Inflammation. Базовые параметры: 40 лет — 64 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Португалия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
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.
Первичные конечные точки
- Gut microbiome functional profile. [Срок оценки: Baseline and every 2 years over a period of 10 years.]
- Gut microbiome taxonomic composition [Срок оценки: Baseline and 2 years over a period of 10 years.]
Вторичные конечные точки (7)
- Female sex hormone levels. [Срок оценки: Baseline and every 2 years over a period of 10 years.]
- Inflammation biomarker levels. [Срок оценки: Baseline and every two years over a period of 10 years.]
- Menopause-related symptoms [Срок оценки: Baseline and every two years over a period of 10 years.]
- Nutritional data [Срок оценки: Baseline and every two years over a period of 10 years.]
- Effect of physical activity on gut microbiota composition [Срок оценки: Baseline and every two years over a period of 10 years.]
- Effect of sleeping habits on gut microbiota composition [Срок оценки: Baseline and every 2 years over a period of 10 years.]
- Effect of stress levels on gut microbiota composition [Срок оценки: Baseline and every 2 years over a period of 10 years.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Португалия · 1 центр
- Gulbenkian Institute for Molecular Medicine, Lisbon — Lisbon
Идентификаторы
NCT: NCT07614542 · CAML Ref nº188/25