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NCT Number: NCT07614542

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

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.

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Key information

Conditions

Menopause Chronic Low-Grade Inflammation Gut Microbiome Hormonal Changes Inflammaging

Age range

40 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gut microbiome functional profile.

    Time frame: Baseline and every 2 years over a period of 10 years.

    Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.

  2. Gut microbiome taxonomic composition

    Time frame: Baseline and 2 years over a period of 10 years.

    Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.

Secondary outcomes

  1. Female sex hormone levels.

    Time frame: Baseline and every 2 years over a period of 10 years.

    Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.

  2. Inflammation biomarker levels.

    Time frame: 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.

  3. Menopause-related symptoms

    Time frame: 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.

  4. Nutritional data

    Time frame: 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).

  5. Effect of physical activity on gut microbiota composition

    Time frame: 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.

  6. Effect of sleeping habits on gut microbiota composition

    Time frame: 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.

  7. Effect of stress levels on gut microbiota composition

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana S Almeida, PhD

CONTACT

[email protected]

+351 217999411

Madalena Reis

CONTACT

[email protected]

+351 217999411

Sponsors and collaborators

Lead sponsor

Gulbenkian Institute for Molecular Medicine

Other

Collaborators

  • Biocodex Microbiota Foundation

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2036
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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