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| Name | Class |
|---|---|
| Biocodex Microbiota Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome functional profile. | 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 | Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages. | Baseline and 2 years over a period of 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Female sex hormone levels. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana S Almeida, PhD | Contact | +351 217999411 | ana.almeida@gimm.pt | |
| Madalena Reis | Contact | +351 217999411 | madalena.reis@gimm.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulbenkian Institute for Molecular Medicine, Lisbon | Recruiting | Lisbon | Portugal |
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Participants will self-collect stool samples using a home collection kit into one tube for microbiome sequencing. Stool samples will be transported to the laboratory within 48 hours and will be subdivided into aliquots and stored at -80°C for subsequent shotgun metagenomics analysis. Blood samples will be collected by Biobank staff, for hormonal, inflammatory, metabolic, and immunological biomarker analysis.
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 | 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 | 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 | 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 | 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 | 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. |