Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

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)

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)

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.

Eligibility

Primary outcome measure(s)

• Total cholesterol concentration — 12 months
  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).
• HDL-C, LDL-C, VLDL-C, and triglyceride concentrations — 12 months
  Measured in serum using reference or enzymatic methods recommended by SEQC.
• Apolipoprotein A1 and B concentrations — 12 months
  Measured with clinical chemistry methods based on SEQC guidelines.
• Aminotransferases: AST (ASAT) and ALT (ALAT) enzyme activity — 12 months
  Measured using enzymatic methods.
• Uric acid, creatinine and glucose concentrations — 12 months
  Measured using standardised spectrophotometric methods.
• Endothelial biomarkers — 12 months
  VCAM-1, ICAM-1, eNOS, E-selectin, and P-selectin concentrations will be measured in serum using ELISA.
• Platelet function markers — 12 months
  Leukotriene B4 and prostaglandin E2 will be measured in serum using ELISAs (Cayman kits).
• Serum cytokines (IL-6, IFN-γ, TNF-α, IL-10) — 12 months
  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.
• C-Reactive Protein (CRP) — 12 months
  CRP will be measured using an automated ultrasensitive turbidimetric method (AU2700 Biochemistry analyser, Olympus).
• Oxidized LDL and 8-hydroxy-2'-deoxyguanosine (8-OHdG) — 12 months
  LDLox and 8-OHdG will be measured in serum using ELISA.
• Lipid peroxidation (TBARS) — 12 months
  TBARS will be measured as µM MDA equivalents using ELISA.
• TAS will be assessed using a colorimetric assay or ELISA. — 12 months
  TAS will be assessed using a colorimetric assay or ELISA.
• Total oxidative status (TOS) — 12 months
  TOS will be measured using ELISA.
• Antioxidant enzyme activities (NOX, GSH, GPx, SOD) — 12 months
  NADPH oxidase (NOX), glutathione (GSH), glutathione peroxidase (GPx), and superoxide dismutase (SOD) will be measured using ELISA-based methods.

Trial sites (1)

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