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Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

NCT06992323 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

  • Hypertriglyceridemia
  • Normal

Interventions

DIETARY_SUPPLEMENT

EPA + HT

Volunteers will consume during 12 weeks 2 g/d of EPA and 15 mg/d of HT, corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks)

DIETARY_SUPPLEMENT

EPA

Volunteers will consume during 12 weeks 2 g/d of EPA corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks)

DIETARY_SUPPLEMENT

Sunflower Oil

Volunteers will consume during 12 weeks 2 g/d of Sunflower Oil, corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks)

Sponsors & Collaborators

  • Beps Holding GmbH

    collaborator UNKNOWN

  • Olivenova Health Sl

    collaborator UNKNOWN

  • National Research Council, Spain

    lead OTHER_GOV

Principal Investigators

  • Raquel Mateos Briz Tenured Scientist · National Research Council (CSIC)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06992323 on ClinicalTrials.gov