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ACTIVE NOT RECRUITING
NCT06992323
NA

Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

Sponsor: National Research Council, Spain

View on ClinicalTrials.gov

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.

Official title: Cardiometabolic Properties of Omega-3 Funcionalized With Hydroxytyrosol in Healthy and Cardiovascular Risk Population

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2025-02-17

Completion Date

2026-12

Last Updated

2025-05-28

Healthy Volunteers

Yes

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)

Locations (1)

Institute of Food Science, Food Technology and Nutrition (ICTAN), CSIC

Madrid, Madrid, Spain