Status:
ACTIVE_NOT_RECRUITING
Polyphenol Metabolism and Personalized Nutrition in Menopause (PolyPause).
Lead Sponsor:
National Research Council, Spain
Collaborating Sponsors:
Hospital Universitario Virgen de la Arrixaca
IMDEA Food
Conditions:
Menopause Related Conditions
Cardiovascular Risk
Eligibility:
FEMALE
45-57 years
Phase:
NA
Brief Summary
The study aims to evaluate the role of the gut microbiome and phageome in explaining interindividual variability in the metabolic response to polyphenol-rich nutraceuticals among menopausal women. Ins...
Detailed Description
This trial aims to investigate the role of the gut microbiome and phageome in mediating interindividual variability in the metabolic response to polyphenol-rich plant extracts among postmenopausal wom...
Eligibility Criteria
Inclusion
- Women aged 45 to 57 years.
- Diagnosed menopause (defined as 12 consecutive months without menstruation).
- Presenting at least one climacteric symptom (hot flashes and/or sweating episodes and/or low mood and/or irritability and/or decreased libido and/or insomnia and/or joint/muscle pain).
- Body Mass Index (BMI) ≥ 18 kg/m².
- Adequate cultural level and ability to understand the clinical study.
- Willing to voluntarily participate in the study and provide written informed consent.
Exclusion
- Presence of severe, chronic-degenerative, or psychiatric conditions, or any contraindication to the use of nutritional supplements.
- History of major gastrointestinal surgery.
- Swallowing difficulties (e.g., inability to ingest capsules).
- BMI \< 18 kg/m² or \> 30 kg/m².
- Currently following a weight-loss regimen.
- Known or suspected allergy or intolerance to red clover extract, resveratrol (grape, wine), soy, or pomegranate.
- Use of chronic preventive medication for cholesterol, glucose, blood pressure, etc. (e.g., statins, metformin, beta-blockers).
- Use of antibiotics within one month prior to study initiation.
- Undergoing hormone replacement therapy.
- Alcohol consumption exceeding 1 beer or 1 glass of wine per day.
- Regular use of dietary supplements (e.g., probiotics, isoflavones, resveratrol, others).
- Following a vegetarian diet.
- Current smoker or having smoked at any time during the past year.
- Individuals unwilling to comply with study guidelines.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07182370
Start Date
January 15 2024
End Date
August 31 2027
Last Update
September 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)
Murcia, Murcia, Spain, 30100