Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol

NCT ID: NCT06992323

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-12-31

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.

Detailed Description

The product to be tested is a combination of two key components: an oily preparation containing 97% eicosapentaenoic acid (EPA) and a natural extract (Oleacore®) with a high hydroxytyrosol content (10%). Oleacore® is naturally derived from olives using exclusively physical and mechanical methods and is commercialized by Olivenova Health SL (https://olivenova.com/es/). The EPA-97% component is supplied by Beeps Holding GMBH (https://bepsholding.com/el-holding/?lang=es). Three types of nutraceutical formulations will be prepared, and study participants will consume three capsules daily to achieve the following dosages:

1. 2 g of EPA + 15 mg of hydroxytyrosol (HT) (3 Type-1 capsules, EPA+HT),

2. 2 g of EPA (3 Type-2 capsules, EPA), and

3. 2 g of seed oil (sunflower) as a placebo (3 Type-3 capsules, Placebo).

The daily dose of 15 mg HT was selected based on the EFSA claim for the prevention of LDL oxidation , while the 2 g EPA dose was established following EFSA recommendations for triglyceride reduction.

A chronic, randomized, controlled, crossover, double-blind, free-living study design is proposed, spanning 46 weeks. Following a two-week washout period, during which the consumption of extra virgin olive oil, and olives will be restricted, participants will be grouped based on baseline characteristics (control or hypertriglyceridemia). They will then be randomized into three groups (randomization performed using SPSS software), such that one-third of participants will receive EPA+HT, another third will receive EPA without HT, and the remaining third will receive a placebo nutraceutical containing sunflower oil with no EPA or HT.

Each intervention phase will last 12 weeks. After completing one intervention, participants will undergo a four-week washout period before transitioning to the next intervention. Before the start of each phase, participants will be provided with all necessary capsules (EPA+HT, EPA, or placebo) along with detailed consumption guidelines.Volunteers will take the capsules with lunch and dinner.

Additionally, during the study, volunteers will consume a commercial olive oil with a minimal phenol content as their culinary oil. This olive oil will also be supplied by the research team for family use (1 L/2 weeks). Participants will be instructed to maintain their usual lifestyle throughout the study but will be restricted from consuming any other culinary oils apart from the one provided by the research group, as well as olives. Furthermore, the use of dietary supplements containing antioxidants, other than vitamins, will be prohibited.

Participants will attend the Human Nutrition Unit (UNH) at ICTAN-CSIC on six occasions, corresponding to the beginning and end of each intervention phase. Once eligibility has been confirmed based on the inclusion and exclusion criteria, participants will attend the UNH for signing the informed consent, receiving olive oil for household consumption, and receiving instructions to begin the study.

During visits V1-V6 (corresponding to the start and end of each intervention with the different nutraceuticals), participants will report to the UNH at ICTAN-CSIC. Upon arrival, they will provide a fasting urine sample from their first morning void and a stool sample collected within the previous 24 hours. Additionally, a trained nurse will collect a fasting blood sample (40 mL, distributed into tubes containing various anticoagulants).

Blood pressure and heart rate will also be measured. Furthermore, participants will undergo a comprehensive anthropometric and body composition assessment. Dietary habits and physical activity levels will be monitored and evaluated during these visits.

Compliance with the intervention will be monitored through monthly telephone follow-ups, the collection of unused capsules, and the measurement of specific biomarkers, including plasma phosphatidylcholine-EPA levels as a marker of omega-3 fatty acid intake and urinary HT metabolites.

Conditions

Hypertriglyceridemia; Normal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

EPA + HT

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

Group Type: EXPERIMENTAL

EPA + HT

Intervention Type: 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

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

Group Type: EXPERIMENTAL

EPA

Intervention Type: 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)

Sunflower oil (SO)

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

Group Type: ACTIVE_COMPARATOR

Sunflower Oil

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beps Holding GmbH

UNKNOWN

Sponsor Role: collaborator

Olivenova Health Sl

UNKNOWN

Sponsor Role: collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role: lead

Responsible Party

María Raquel Mateos Briz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel Mateos Briz Tenured Scientist

Role: PRINCIPAL_INVESTIGATOR

National Research Council (CSIC)

Locations

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

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

HYDROXYOMEGA

Identifier Type: -

Identifier Source: org_study_id