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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
Gulbenkian Institute for Molecular Medicine, Lisbon
Lisbon, Portugal
RECRUITINGGut microbiome functional profile.
Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.
Time frame: Baseline and every 2 years over a period of 10 years.
Gut microbiome taxonomic composition
Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.
Time frame: Baseline and 2 years over a period of 10 years.
Female sex hormone levels.
Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
Time frame: Baseline and every 2 years over a period of 10 years.
Inflammation biomarker levels.
Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
Time frame: Baseline and every two years over a period of 10 years.
Menopause-related symptoms
Self-reported menopausal symptoms will be assessed via online questionnaires that include reproductive, medical history and associated symptoms.
Time frame: Baseline and every two years over a period of 10 years.
Nutritional data
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).
Time frame: Baseline and every two years over a period of 10 years.
Effect of physical activity on gut microbiota composition
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.
Time frame: Baseline and every two years over a period of 10 years.
Effect of sleeping habits on gut microbiota composition
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.
Time frame: Baseline and every 2 years over a period of 10 years.
Effect of stress levels on gut microbiota composition
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.
Time frame: Baseline and every 2 years over a period of 10 years.
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