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

NCT07614542 | Recruiting

• 1 other identifier: CAML Ref nº188/25
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopause; Gut Microbiome; Hormonal Changes; Chronic Low-Grade Inflammation; Inflammaging

Keywords

microbiome; biomarkers; metagenomics; menopausal transition; women's health

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (7)

• Female sex hormone levels.

  Baseline and every 2 years over a period of 10 years.

• Inflammation biomarker levels.

  Baseline and every two years over a period of 10 years.

• Menopause-related symptoms

  Baseline and every two years over a period of 10 years.

• Nutritional data

  Baseline and every two years over a period of 10 years.

• Effect of physical activity on gut microbiota composition

  Baseline and every two years over a period of 10 years.

Study Arms (3)

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.

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulbenkian Institute for Molecular Medicine: lead
• Biocodex Microbiota Foundation: collaborator

Study Sites (1)

Gulbenkian Institute for Molecular Medicine, Lisbon

Lisbon, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

Central Study Contacts

Ana S Almeida, PhD

CONTACT

+351 217999411; ana.almeida@gimm.pt

Madalena Reis

CONTACT

+351 217999411; madalena.reis@gimm.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 29, 2026
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

PT (1)