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Metabotyping in the Postmenopausal Stage

NCT05397015 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-03-16

No results posted yet for this study

Summary

Menopause is defined as the absence of menstrual periods for twelve consecutive months. Although the onset may vary, natural menopause occurs between the ages of 45 and 55 and is considered a stage in the aging process for women. Menopause is a stage strongly conditioned by hormonal modulations with effects on the cardiovascular system associated with abdominal obesity, insulin resistance, decreased energy expenditure, endothelial dysfunction, hypertension, and dyslipidemia. Furthermore, an increase in the production of proinflammatory cytokines involved in numerous pathologies such as osteoporosis has been observed.

The results of several studies suggest that intestinal microbiota (IM) profile may be related to menopause condition by several means, although the data are stil inconclusive.

Estrogen reduction leads to a progressive loss of bone density, a reduction in the bone formation/resorption balance and an increased risk of bone fractures among postmenopausal women. Recently, the alternative to estrogen therapies to reduce the risk of fractures are nutritional strategies fundamentally based on the use of probiotics, whose effect are associated with beneficial modulations of IM.

SHE-HEALTH is a study in which, in a cohort of postmenopausal women, metabolomics, transcriptomics and metagenomics will be combined with the analysis of usual anthropometric and clinical biomarkers and also with genetic and epigenetic analyses to identify population groups (clusters). This study will allow establishing solid scientific bases to define, in future projects, effective nutritional strategies based on group nutrition in postmenopausal women.

The main objective of the present study is to obtain clusters of postmenopausal women, identifying metabotypes (similar metabolic profiles) and enterotypes (similar IM profiles), and combining complementary variables such as classical anthropometric, biochemical and clinical biomarkers.

The secondary objectives of the study are to characterize: 1) The genetic profile of the study cohort; 2) The epigenetic profile of the study cohort; 3) The gene expression profile of the study cohort.

Conditions

  • Menopause
  • Postmenopausal Disorder
  • Postmenopausal Symptoms

Interventions

OTHER

No intervention will be done

No intervention will be done

Sponsors & Collaborators

  • Fundació Eurecat

    lead OTHER

Principal Investigators

  • Antoni Caimari, PhD · Eurecat-Reus

Eligibility

Min Age
40 Years
Max Age
63 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2022-11-29
Completion
2022-11-29

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397015 on ClinicalTrials.gov