AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing
2026년 5월 22일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
관찰
등록 (추정된)
300
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ana S Almeida, PhD
- 전화번호: +351 217999411
- 이메일: ana.almeida@gimm.pt
연구 연락처 백업
- 이름: Madalena Reis
- 전화번호: +351 217999411
- 이메일: madalena.reis@gimm.pt
연구 장소
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Lisbon, 포르투갈
- 모병
- Gulbenkian Institute for Molecular Medicine, Lisbon
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연락하다:
- Ana S Almeida, PhD
- 전화번호: +351 217999411
- 이메일: ana.almeida@gimm.pt
-
연락하다:
- Madalena Reis
- 전화번호: +351 217999411
- 이메일: madalena.reis@gimm.pt
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수석 연구원:
- Ana S Almeida, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Premenopausal women (self-reported)
Regular menstrual periods, with no signs of menopause yet.
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Perimenopausal women (self-reported)
Irregular menstrual periods, presence of some menopausal symptoms, such as hot flashes, mood changes, sleep disturbances, and brain fog.
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Menopausal/Postmenopausal women (self-reported)
Absence of menstruation for 12 consecutive months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gut microbiome functional profile.
기간: Baseline and every 2 years over a period of 10 years.
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Changes in microbial gene functions and metabolic pathways derived from metagenomic analysis.
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Baseline and every 2 years over a period of 10 years.
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Gut microbiome taxonomic composition
기간: Baseline and 2 years over a period of 10 years.
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Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.
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Baseline and 2 years over a period of 10 years.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Female sex hormone levels.
기간: Baseline and every 2 years over a period of 10 years.
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Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
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Baseline and every 2 years over a period of 10 years.
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Inflammation biomarker levels.
기간: Baseline and every two years over a period of 10 years.
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Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
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Baseline and every two years over a period of 10 years.
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Menopause-related symptoms
기간: Baseline and every two years over a period of 10 years.
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Self-reported menopausal symptoms will be assessed via online questionnaires that include reproductive, medical history and associated symptoms.
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Baseline and every two years over a period of 10 years.
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Nutritional data
기간: Baseline and every two years over a period of 10 years.
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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).
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Baseline and every two years over a period of 10 years.
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Effect of physical activity on gut microbiota composition
기간: Baseline and every two years over a period of 10 years.
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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.
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Baseline and every two years over a period of 10 years.
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Effect of sleeping habits on gut microbiota composition
기간: Baseline and every 2 years over a period of 10 years.
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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.
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Baseline and every 2 years over a period of 10 years.
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Effect of stress levels on gut microbiota composition
기간: Baseline and every 2 years over a period of 10 years.
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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.
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Baseline and every 2 years over a period of 10 years.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 6월 2일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2036년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 11일
QC 기준을 충족하는 최초 제출
2026년 5월 22일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 22일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .