Actively Recruiting

Age: 40Years - 64Years
FEMALE
ID07614542

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

Led by Gulbenkian Institute for Molecular Medicine · Updated on 2026-05-29

300

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

G

Gulbenkian Institute for Molecular Medicine

Lead Sponsor

B

Biocodex Microbiota Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how changes in the gut microbiome relate to hormonal changes during women's ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in women's health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 64Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline and every 2 years over a period of 10 years

Participants provide stool and blood samples and complete questionnaires to assess gut microbiome, hormone levels, inflammation, symptoms, nutrition, physical activity, sleeping habits, and stress.

Visits every 2 years for up to 10 years

Long-term Monitoring

Duration - 10 years

Participants are observed over time to track changes in the gut microbiome, hormone levels, inflammation biomarkers, and menopause-related symptoms.

Visits every 2 years for up to 10 years

Trial Site Locations

Total: 1 location

1

Gulbenkian Institute for Molecular Medicine, Lisbon

Lisbon, Portugal

Actively Recruiting

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Research Team

A

Ana S Almeida, PhD

M

Madalena Reis

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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