AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-64
SponsorGulbenkian Institute for Molecular Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female sex
Aged 40 to 64 years
Resident in mainland Portugal or the islands
Able and willing to provide written informed consent
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Premenopausal women (self-reported)
Group B: Perimenopausal women (self-reported)
Group C: Menopausal/Postmenopausal women (self-reported)
Trial outcomes
Primary outcomes
1
Gut microbiome functional profile.
Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.
Time frame
Baseline and every 2 years over a period of 10 years.2
Gut microbiome taxonomic composition
Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.
Time frame
Baseline and 2 years over a period of 10 years.Secondary outcomes
1
Female sex hormone levels.
Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
Time frame
Baseline and every 2 years over a period of 10 years.2
Inflammation biomarker levels.
Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
Time frame
Baseline and every two years over a period of 10 years.3
Menopause-related symptoms
Self-reported menopausal symptoms will be assessed via online questionnaires that include reproductive, medical history and associated symptoms.
Time frame
Baseline and every two years over a period of 10 years.4
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).
Time frame
Baseline and every two years over a period of 10 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gulbenkian Institute for Molecular Medicine
Lead sponsor
Biocodex Microbiota Foundation
Collaborator
Source ClinicalTrials.gov