Clinical trial NCT05397015: Metabotyping in the Postmenopausal Stage
Official title: Metabotyping in the Postmenopausal Stage: Cross-Sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Postmenopausal Disorder
Postmenopausal Symptoms
Keywords: Metabolomics
Transcriptomics
Metagenomics
Personalized Nutrition
Metabotypes
Enterotypes
Lead sponsor: Fundació Eurecat
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women between 40 and 63 years old with amenorrhea for a period of time equal or greater than 12 months.
* Without hormone replacement therapy.
* Sign the informed consent.

Exclusion Criteria:

* Women diagnosed with diabetes (or serum glucose ≥ 126 mg/dL) or other chronic pathologies (coronary, cardiovascular, celiac disease, Crohn's disease and chronic kidney diseases (or serum creatinine ≥ 1.5 mg/dL).
* Women taking medications prescribed for hypertension and dyslipidemia. Women who have consumed during the week prior to start to start of the study anti-inflammatory drugs.
* women with chronic gastrointestinal problems.
* Women with a body mass index (in kg/m2) \<18 or ≥35.
* Women who are participating in another clinical trial or following a prescribed diet for any reason, including weigh loss, during the last month.
* Women who consume more than 14 alcoholic beverages per week.
* Women current smokers.

Primary outcomes:
measure: Metabolomics in serum
timeFrame: At day 1
measure: Metabolomics in erythrocytes
timeFrame: At day 1
measure: Metabolomics in urine
timeFrame: At day 1
measure: Metagenomics in faeces
timeFrame: At day 1
measure: Serum hsCRP levels
timeFrame: At day 1
measure: Serum IL-6 levels
timeFrame: At day 1
measure: Serum TNFalpha levels
timeFrame: At day 1
measure: Serum BALP levels
timeFrame: At day 1
measure: Serum osteocalcin levels
timeFrame: At day 1
measure: Serum TRAP5b levels
timeFrame: At day 1
measure: Serum CTX-I levels
timeFrame: At day 1
measure: Serum PINP levels
timeFrame: At day 1
measure: Serum FSH levels
timeFrame: At day 1
measure: Serum 17beta E2 levels
timeFrame: At day 1
measure: Serum inhibin B levels
timeFrame: At day 1
measure: Serum testosterone levels
timeFrame: At day 1
measure: Serum AMH levels
timeFrame: At day 1
measure: Serum SHBG levels
timeFrame: At day 1
measure: Serum triglycerides levels
timeFrame: At day 1
measure: Serum total cholesterol levels
timeFrame: At day 1
measure: Serum LDL-cholesterol levels
timeFrame: At day 1
measure: Serum HDL-cholesterol levels
timeFrame: At day 1
measure: Serum glucose levels
timeFrame: At day 1
measure: Serum insulin levels
timeFrame: At day 1
measure: Homeostatic Model Assessment from Insulin Resistance index (HOMA-IR)
timeFrame: At day 1
measure: Serum ALT levels
timeFrame: At day 1
measure: Serum AST levels
timeFrame: At day 1
measure: Serum creatinine levels
timeFrame: At day 1
measure: Serum uric acid levels
timeFrame: At day 1
measure: Serum urea levels
timeFrame: At day 1
measure: Urine 8-OHdG levels
timeFrame: At day 1
measure: Urine F2-isoprostanes levels
timeFrame: At day 1
measure: Urine NTX levels
timeFrame: At day 1
Secondary outcomes:
measure: Body weight
timeFrame: At day 1
measure: Height
timeFrame: At day 1
measure: Body mass index
timeFrame: At day 1
measure: Waist circumference
timeFrame: At day 1
measure: Blood pressure (in mmHg)
timeFrame: At day 1
measure: Waist circumference to height ratio
timeFrame: At day 1
measure: Body composition
timeFrame: At day 1
measure: Dietary intake
timeFrame: At day 1
measure: Transcriptomics analysis in hair follicles.
timeFrame: At day 1
measure: Transcriptomics analysis in total blood.
timeFrame: At day 1
measure: MicroRNAs analysis in total blood.
timeFrame: At day 1
measure: DNA methylation analysis in total blood.
timeFrame: At day 1
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Eurecat
Study officials:
affiliation: Eurecat-Reus
name: Antoni Caimari, PhD
role: PRINCIPAL_INVESTIGATOR
References: