Polyphenol Metabolism and Personalized Nutrition in Menopause (PolyPause). (NCT07182370) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Polyphenol Metabolism and Personalized Nutrition in Menopause (PolyPause).
Spain90 participantsStarted 2024-01-15
Plain-language 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. Insights from this research will support the development of personalized nutrition strategies to improve quality of life and reduce cardiovascular disease (CVD) risk during menopause.
Who can participate
Age range45 Years – 57 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 wi…
What they're measuring
1
Oxidized LDL particles (LDLox)
Timeframe: Change from baseline at 8 weeks compared to placebo