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Starting soon Phase 2

Erythrodiol in Pomace Olive Oil as a Protective Agent Against Atherosclerosis

NCT07422051 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2026-02-21
Last updated
2026-02-19

Condition(s) studied

Atherosclerosis Cardiovascular Disease

Investigational drug(s) / intervention(s)

Low erythrodiol doseMedium erythrodiol doseHigh erythrodiol dose

Low erythrodiol dose: Low erythrodiol dose

Medium erythrodiol dose: Medium erythrodiol dose

High erythrodiol dose: High erythrodiol dose

Study summary

The goal of this postprandial clinical trial is to learn whether erythrodiol, a triterpene naturally present in pomace olive oil, can modulate the cell foam formation, ine of the first steps in atherosclerosis. The main questions it aims to answer are:

Is erythrodiol bioavailable in humans when administered as pomace olive oil? Does acute erythrodiol intake reduce postprandial triglyceride excursions after a high-fat meal? Does erythrodiol reduce the intake of postprandial triglyceride-rich lipoproteins by macrophages?

Researchers will compare participants receiving test meals enriched with different concentrations of erythrodiol (low, medium, high) to see if the intervention leads to improved postprandial metabolic and vascular responses.

Participants will:

Attend the research facility after an overnight fast. Consume a high-fat test meal enriched with a different doses of erythrodiol

Undergo serial postprandial assessments over several hours, including:

Blood sampling for lipids, glucose, inflammatory markers, and oxidative stress biomarkers Monitoring of subjective tolerability and adverse events

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 18 to 40 years. * Male or female volunteers. * Healthy individuals with no diagnosed diseases. * Normal-weight participants with a Body Mass Index (BMI) between 18.5 and 24.9 kg/m². * Ability to provide voluntary informed consent. * Willingness to comply with all study procedures. * Availability to participate in the two-phase selection process, including initial screening and subsequent laboratory tests. Exclusion Criteria: * Presence of any type of disease, including digestive, metabolic, endocrine, infectious, neoplastic conditions, or associated allergies and food intolerances. * Current use of any medication, except hormonal contraceptives. * Pregnant or breastfeeding women. * Participation in a clinical trial with an investigational product within the last 60 days, or current enrolment in a clinical trial. * Any physical or intellectual limitation that, in the opinion of the investigator, could impede following or completing the study protocol.

Primary outcome measure(s)

  • Plasma erythrodiol concentration — 4 months since the last intervention session

Trial sites (1)

FacilityCityRegionStatus
Instituto de la Grasa-CSIC Seville Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07422051 on ClinicalTrials.gov ↗ ← All trials in Spain