Metabotyping in the Postmenopausal Stage
Condition: Menopause; Postmenopausal Disorder; Postmenopausal Symptoms
Study type: Observational

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.
    

Detailed description: 
      Cross-sectional observational study in which samples of blood, faeces, urine, hair and hair
      follicles will be collected to characterize the metabolic profile, intestinal microbiota
      (IM), gene expression profile, genetic and epigenetic profile of postmenopausal women. Data
      on lifestyle habits, anthropometric measurements and nutritional and hormonal status will
      also be collected.

      The study will be conducted in a cohort of 200 postmenopausal women.

      Each volunteer will make 2 visits:

        -  A pre-selection visit (to check inclusion/exclusion criteria) (V0) and, if the inclusion
           criteria are met,

        -  A study visit (V1) in which samples will be collected from faeces, urine, blood, hair
           and hair follicles.

      In V1, the participants must present themselves fasting for 8 hours to obtain blood and urine
      collected during the last 24 hours. In addition, during the visit the sample of hair and hair
      follicles will be collected. Participants are given a basic guide of healthy eating and
      lifestyle recommendations suitable for postmenopausal stage.
    

Intervention name(s): No intervention will be done
Intervention type(s): Other
Intervention description(s): No intervention will be done
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The cohort of the study will be selected from the general population.
      
Biospecimen description: 
      Samples of blood, faeces, urine, hair and hair follicles will be collected
    
Keywords: Metabolomics; Transcriptomics; Metagenomics; Personalized Nutrition; Metabotypes; Enterotypes