Polyphenol Metabolism and Personalized Nutrition in Menopause (PolyPause).

What this trial studies

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.

Conditions in scope

• Menopause Related Conditions
• Cardiovascular Risk

Interventions

• Capsules containing plant extracts, including resveratrol, ellagic acid and isoflavones (Dietary Supplement) — Eight-week intake of three capsules per day, containing a total of 2.1 g of plant extracts (PPs), including 150 mg of resveratrol (found in grapes and red wine), 100 mg of ellagic acid (present in strawberries, walnuts, pomegranate, etc.), and…
• Consumption of placebo (Dietary Supplement) — Daily intake of three capsules (2.1 g/day) of microcrystalline cellulose for eight weeks

Who can join

Women only · Ages 45 Years to 57 Years

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-01-15
• Primary completion: 2025-07-01
• Last update posted: 2025-09-19
• First posted: 2025-09-19

Sponsor & contact

Lead sponsor: National Research Council, Spain (Other Gov)

Collaborators: Hospital Universitario Virgen de la Arrixaca, IMDEA Food

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Oxidized LDL particles (LDLox) (Change from baseline at 8 weeks compared to placebo)
  15% change in serum oxidized LDL concentration (U/L) by ELISA

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.