Status:

COMPLETED

Metabotyping in the Postmenopausal Stage

Lead Sponsor:

Fundació Eurecat

Conditions:

Menopause

Postmenopausal Disorder

Eligibility:

FEMALE

40-63 years

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...

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 expressi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 16 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 29 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT05397015

Start Date

April 16 2021

End Date

November 29 2022

Last Update

March 16 2023

Active Locations (1)

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Eurecat

Reus, Spain, 43204