Erythrodiol in Pomace Olive Oil as a Protective Agent Against Atherosclerosis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSpanish National Research Council

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Low erythrodiol dose
  • Medium erythrodiol dose
  • High erythrodiol dose

Treatment groups

22 Participants
are divided into 3 treatment groups