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

May 22, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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 (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Gulbenkian Institute for Molecular Medicine, Lisbon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana S Almeida, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and every 2 years over a period of 10 years.
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.
Baseline and 2 years over a period of 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and every 2 years over a period of 10 years.
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.
Baseline and every two years over a period of 10 years.
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.
Baseline and every two years over a period of 10 years.
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).
Baseline and every two years over a period of 10 years.
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.
Baseline and every two years over a period of 10 years.
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.
Baseline and every 2 years over a period of 10 years.
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.
Baseline and every 2 years over a period of 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulbenkian Institute for Molecular Medicine

Collaborators

Biocodex Microbiota Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAML Ref nº188/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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