MenopauseNCT07614542
AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
An observational study of Menopause and Gut Microbiome, run by Gulbenkian Institute for Molecular Medicine at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women only
- Conditions the study is for
- Menopause, Gut Microbiome, Hormonal Changes
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jun 2025to Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Gulbenkian Institute for Molecular Medicine, Lisbon
Lisbon
Madalena Reis, +351 217999411, madalena.reis@gimm.pt
Ana S Almeida, PhD, +351 217999411, ana.almeida@gimm.pt
About this study
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.
Read the 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.
- Keywords
- microbiome, biomarkers, metagenomics, menopausal transition, women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome functional profile.
Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.
Measured: 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.
Measured: Baseline and 2 years over a period of 10 years.
Secondary outcomes (7)
Female sex hormone levels.
Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
Measured: Baseline and every 2 years over a period of 10 years.
Inflammation biomarker levels.
Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and every 2 years over a period of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start2 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulbenkian Institute for Molecular Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Biocodex Microbiota Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614542
- Sponsor's protocol ID
- CAML Ref nº188/25
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
- ClinicalTrials.gov ID
- NCT07614542
- Acronym / sponsor ID
- CAML Ref nº188/25
- Keywords
- microbiome, biomarkers, metagenomics, menopausal transition, women's health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gulbenkian Institute for Molecular MedicineUniversity, hospital or other
- Collaborators
- Biocodex Microbiota Foundation
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
7 secondary outcomes
Female sex hormone levels.
Time frame: 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.
Menopause-related symptoms
Time frame: 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.
Effect of physical activity on gut microbiota composition
Time frame: 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.
Effect of stress levels on gut microbiota composition
Time frame: Baseline and every 2 years over a period of 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Gut Microbiome, run by Gulbenkian Institute for Molecular Medicine at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana S Almeida, PhD (+351 217999411, ana.almeida@gimm.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome functional profile. (time frame: Baseline and every 2 years over a period of 10 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.