Erythrodiol in Pomace Olive Oil as a Protective Agent Against Atherosclerosis

NCT07422051 | Not Yet Recruiting Phase 2

• 1 other identifier: ORIVA24041961
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atherosclerosis Cardiovascular Disease

Keywords

Randomized postprandial crossover trial; Erythrodiol; Pomace olive oil; Atherosclerosis; Macrophages

Outcome Measures

Primary Outcomes (1)

• Plasma erythrodiol concentration

  4 months since the last intervention session

Secondary Outcomes (2)

• Plasma triglyceride concentration

  4 months since the last intervention session

• Inflammation marker concentration in plasma

  4 months since the last intervention session

Study Arms (3)

Low erythrodiol

ACTIVE COMPARATOR

Other: Low erythrodiol dose

Medium erythrodiol

ACTIVE COMPARATOR

Other: Medium erythrodiol dose

High erythrodiol

ACTIVE COMPARATOR

Other: High erythrodiol dose

Interventions

Low erythrodiol dose OTHER

Low erythrodiol dose

Low erythrodiol

Medium erythrodiol dose OTHER

Medium erythrodiol dose

Medium erythrodiol

High erythrodiol dose OTHER

High erythrodiol dose

High erythrodiol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish National Research Council: lead

Study Sites (1)

Instituto de la Grasa-CSIC

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Javier Perona S. Perona, PhD

CONTACT

34954611550; perona@ig.csic.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Researcher

Model Details: This study uses a randomized, postprandial, crossover interventional design, in which each participant receives all three test conditions (low, medium, and high erythrodiol doses) in separate visits. Participants act as their own controls, and each intervention is separated by a washout period of 4 weeks to avoid carry-over effects.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 19, 2026
• Study Start: February 21, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)