Polyphenol Metabolism and Personalized Nutrition in Menopause (PolyPause).

NCT07182370 | Active Not Recruiting

• 1 other identifier: PID2022-136419OB-I00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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

Menopause Related Conditions; Cardiovascular Risk

Keywords

Menopause; Microbiome; Phageome; Cardiovascular risk; Gut dysbiosis; Quality of life; LDLox; TMAO; Bile acids; Blood lipids; resveratrol; pomegranate; urolithin; isoflavones; equol; Metabotype; Personalized nutrition; Lunularin; Ellagic acid; Endotoxemia; Short-chain farry acids

Outcome Measures

Primary Outcomes (1)

• Oxidized LDL particles (LDLox)

  15% change in serum oxidized LDL concentration (U/L) by ELISA

  Change from baseline at 8 weeks compared to placebo

Secondary Outcomes (12)

• Gut microbiome

  Change from baseline at 8 weeks compared to placebo

• Gut phageome

  Change from baseline at 8 weeks compared to placebo

• Blood lipids

  Change from baseline at 8 weeks compared to placebo

• Trimethylamine N-oxide (TMAO)

  Change from baseline at 8 weeks compared to placebo

• Lipopolysaccharide binding protein (LBP)

  Change from baseline at 8 weeks compared to placebo

Study Arms (4)

Polyphenol-rich capsules (PPs-A)

EXPERIMENTAL

Consumption of polyphenol-rich plant extrats (PPs).

Dietary Supplement: Capsules containing plant extracts, including resveratrol, ellagic acid and isoflavones

(Placebo-A)

PLACEBO COMPARATOR

Consumption of microcrystalline cellulose (placebo).

Dietary Supplement: Consumption of placebo

Polyphenol-rich capsules (PPs-B)

EXPERIMENTAL

Consumption of polyphenol-rich plant extracts (PPs).

Dietary Supplement: Capsules containing plant extracts, including resveratrol, ellagic acid and isoflavones

(Placebo-B)

PLACEBO COMPARATOR

Consumption of microcrystalline cellulose (placebo).

Dietary Supplement: Consumption of placebo

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 50 mg of the isoflavone daidzein, among others (found in soy, red clover, etc.).

Polyphenol-rich capsules (PPs-A); Polyphenol-rich capsules (PPs-B)

Consumption of placebo DIETARY_SUPPLEMENT

Daily intake of three capsules (2.1 g/day) of microcrystalline cellulose for eight weeks

(Placebo-A); (Placebo-B)

Eligibility Criteria

• Age: 45 Years - 57 Years
• Gender Eligibility Details: Only individuals assigned female at birth who self-identify as women are eligible to participate, provided they meet the biological criteria for postmenopause as defined in the study protocol. While gender identity is fully respected, eligibility is determined by biological sex due to the physiological nature of the condition under investigation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead
• Hospital Universitario Virgen de la Arrixaca: collaborator
• IMDEA Food: collaborator

Study Sites (1)

Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)

Murcia, Murcia, 30100, Spain

Location

MeSH Terms

Conditions

Endotoxemia

Interventions

Ellagic Acid; Isoflavones

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavonoids; Chromones

Study Officials

• Juan C. Espín, PhD

  Spanish National Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Research Professor

Model Details: Crossover Assignment. Randomized, double-blind, placebo-controlled and crossover trial.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 19, 2025
• Study Start: January 15, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Time Frame: Beginning 12 months after publication of the results; available for 5 years.
• Access Criteria: Access Criteria: Qualified researchers may request access by contacting the Principal Investigator. Data will be shared in a controlled manner to ensure confidentiality of participants.

Locations

ES (1)