Clinical Trial

Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

Study acronym: HydroxyOmega
Active, Not Recruiting
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Record status
This record was last updated May 28, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The primary aim of this study is to investigate the potential cardioprotective effects of daily nutritional doses of eicosapentaenoic acid (EPA) enriched with hydroxytyrosol (HT) on cardiovascular health, as well as its modulatory impact on the intestinal microbiota. This investigation will be conducted through a randomized, double-blind, crossover, and controlled nutritional intervention trial. The study population will include two cohorts: one with normotriglyceridemic individuals, and another with hypertriglyceridemic individuals. Participants will be randomly allocated to one of three intervention groups: (1) EPA+HT supplementation, (2) EPA alone, or (3) a placebo consisting of sunflower oil devoid of EPA.
Trial Details
NCT Number NCT06992323
Lead Sponsor National Research Council, Spain
Collaborators: Beps Holding GmbH, Olivenova Health Sl
Conditions Hypertriglyceridemia, Normal
Enrollment 68 participants
Start Date 2025-02-17
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-28