Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

NCT06992323 | Active Not Recruiting

• 1 other identifier: HYDROXYOMEGA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiovascular risk; omega 3; hydroxytyrosol; hypertriglyceridemia

Outcome Measures

Primary Outcomes (14)

• Total cholesterol concentration

  Total cholesterol in serum samples will be determined following reference methods recommended by the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC) using the Roche Cobas Integra 400 plus analyser (Roche Diagnostics).

  12 months

• HDL-C, LDL-C, VLDL-C, and triglyceride concentrations

  Measured in serum using reference or enzymatic methods recommended by SEQC.

  12 months

• Apolipoprotein A1 and B concentrations

  Measured with clinical chemistry methods based on SEQC guidelines.

  12 months

• Aminotransferases: AST (ASAT) and ALT (ALAT) enzyme activity

  Measured using enzymatic methods.

  12 months

• Uric acid, creatinine and glucose concentrations

  Measured using standardised spectrophotometric methods.

  12 months

• Endothelial biomarkers

  VCAM-1, ICAM-1, eNOS, E-selectin, and P-selectin concentrations will be measured in serum using ELISA.

  12 months

• Platelet function markers

  Leukotriene B4 and prostaglandin E2 will be measured in serum using ELISAs (Cayman kits).

  12 months

• Serum cytokines (IL-6, IFN-γ, TNF-α, IL-10)

  Serum concentrations of interleukin-6 (IL-6), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10) will be determined using ELISA. These biomarkers reflect both pro- and anti-inflammatory responses.

  12 months

• C-Reactive Protein (CRP)

  CRP will be measured using an automated ultrasensitive turbidimetric method (AU2700 Biochemistry analyser, Olympus).

  12 months

• Oxidized LDL and 8-hydroxy-2'-deoxyguanosine (8-OHdG)

  LDLox and 8-OHdG will be measured in serum using ELISA.

  12 months

• Lipid peroxidation (TBARS)

  TBARS will be measured as µM MDA equivalents using ELISA.

  12 months

• TAS will be assessed using a colorimetric assay or ELISA.

  TAS will be assessed using a colorimetric assay or ELISA.

  12 months

• Total oxidative status (TOS)

  TOS will be measured using ELISA.

  12 months

• Antioxidant enzyme activities (NOX, GSH, GPx, SOD)

  NADPH oxidase (NOX), glutathione (GSH), glutathione peroxidase (GPx), and superoxide dismutase (SOD) will be measured using ELISA-based methods.

  12 months

Secondary Outcomes (10)

• Systolic and Diastolic Blood Pressure

  12 months

• Resting Heart Rate

  12 months

• Fecal Short Chain Fatty Acids (SCFAs) Concentration

  12 months

• Fecal Lactate Concentration

  12 months

• Gut Microbiota Composition (16S rRNA Gene Profiling)

  12 months

Study Arms (3)

EPA + HT

EXPERIMENTAL

EPA + HT: intake of 2 g/d of EPA and 15 mg/d of HT (3 Type-1 capsules, EPA + HT)

Dietary Supplement: EPA + HT

EPA

EXPERIMENTAL

EPA: intake of 2 g/d of EPA (3 Type-2 capsules, EPA)

Dietary Supplement: EPA

Sunflower oil (SO)

ACTIVE COMPARATOR

Sunflower Oil (SO): intake of 2 g/d of SO (3 Type-3 capsules, Placebo)

Dietary Supplement: Sunflower Oil

Interventions

EPA + HT DIETARY_SUPPLEMENT

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)

EPA + HT

EPA DIETARY_SUPPLEMENT

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)

EPA

Sunflower Oil DIETARY_SUPPLEMENT

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)

Sunflower oil (SO)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 70 years old
• Hypertriglyceridemia (150-250 mg/dl) or normal levels of triglycerides levels (\<150 mg/dl)

You may not qualify if:

• Presence of chronic illnesses
• Currently undergoing pharmacological treatment
• Smoking
• Pregnancy
• Adherence to a vegetarian or vegan diet

Sponsors & Collaborators

• National Research Council, Spain: lead
• Beps Holding GmbH: collaborator
• Olivenova Health Sl: collaborator

Study Sites (1)

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

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Raquel Mateos Briz Tenured Scientist

  National Research Council (CSIC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Chronic, randomized, controlled, cross-over, double-blind, and free-living study

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 28, 2025
• Study Start: February 17, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-04

Locations

ES (1)