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 range

45 Years – 57 Years

Sex

FEMALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oxidized LDL particles (LDLox)

Timeframe: Change from baseline at 8 weeks compared to placebo

Trial details

NCT IDNCT07182370

SponsorNational Research Council, Spain

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Menopause Related Conditions trials