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

2026年5月22日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • ポルトガル
      • Lisbon、ポルトガル
        • 募集
        • Gulbenkian Institute for Molecular Medicine, Lisbon
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Ana S Almeida, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Gut microbiome functional profile.
時間枠：Baseline and every 2 years over a period of 10 years.
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
時間枠：Baseline and 2 years over a period of 10 years.
Changes in faecal microbiome composition assessed by shotgun metagenomic sequencing across menopause stages.
Baseline and 2 years over a period of 10 years.

二次結果の測定

結果測定
メジャーの説明
時間枠
Female sex hormone levels.
時間枠：Baseline and every 2 years over a period of 10 years.
Blood levels of estradiol, FSH, LH, AMH, and cortisol measured by immunoassays.
Baseline and every 2 years over a period of 10 years.
Inflammation biomarker levels.
時間枠：Baseline and every two years over a period of 10 years.
Blood levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β) and TNF-α.
Baseline and every two years over a period of 10 years.
Menopause-related symptoms
時間枠：Baseline and every two years over a period of 10 years.
Self-reported menopausal symptoms will be assessed via online questionnaires that include reproductive, medical history and associated symptoms.
Baseline and every two years over a period of 10 years.
Nutritional data
時間枠：Baseline and every two years over a period of 10 years.
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).
Baseline and every two years over a period of 10 years.
Effect of physical activity on gut microbiota composition
時間枠：Baseline and every two years over a period of 10 years.
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.
Baseline and every two years over a period of 10 years.
Effect of sleeping habits on gut microbiota composition
時間枠：Baseline and every 2 years over a period of 10 years.
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.
Baseline and every 2 years over a period of 10 years.
Effect of stress levels on gut microbiota composition
時間枠：Baseline and every 2 years over a period of 10 years.
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.
Baseline and every 2 years over a period of 10 years.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Gulbenkian Institute for Molecular Medicine

協力者

Biocodex Microbiota Foundation

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年6月2日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2036年12月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月22日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • CAML Ref nº188/25

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米国FDA規制医薬品の研究

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いいえ

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