Enriched QUARTET® Hen Eggs and Cardiovascular Function

NCT04564690 | Unknown

• 1 other identifier: #KK.01.1.1.01.0010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Role of oxidative stress in the development of cardiovascular diseases is well known and extensively investigated, because of its direct effects on vascular function, but also on the activation of the immune response. Thus, food products that could increase the antioxidant capacity of the vascular system would also act protective against cardiovascular diseases. However, we lack systematic clinical and pre-clinical research with food products instead of food supplements, which would result in consistent and repeatable results. Many studies have proven the effectiveness of n-3 polyunsaturated fatty acids (n-3 PUFA) in improvement of endothelial function, improvement of elasticity of the vascular wall and the anti-inflammatory effects in patients with chronic diseases, such as metabolic syndrome, if they are taken as an pharmacological preparation. Our research group recently reported that favorable anti-inflammatory properties of n-3 PUFA enriched hen eggs potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals. In addition, this study aimed to determine the effect of QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein; QUARTET No. 012743696, 2014.) consumption on cardiovascular function in both healthy individuals and cardiovascular patients.

Conditions

n-3 Polyunsaturated Fatty Acids; Selenium; Vitamin E; Lutein

Keywords

n-3 polyunsaturated fatty acids; selenium; vitamin E; lutein; vascular function; endothelium; cardiovascular health

Outcome Measures

Primary Outcomes (9)

• Microvascular reactivity

  Forearm skin microvascular reactivity in response to: vascular occlusion (post-occlusion reactive hyperemia, PORH); iontophoresis of acetylcholine (endothelium-dependent) and sodium nitroprusside (endothelium-independent); and local thermal hyperemia (LTH, NO-dependent vasodilation), measured by laser Doppler flowmetry (LDF)

  3 weeks

• Macrovascular reactivity - FMD of brachial artery

  Flow mediated dilation (FMD) of brachial artery measured by ultrasound.

  3 weeks

• Macrovascular reactivity - TCD of cerebral blood vessels

  Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).

  3 weeks

• Oxidative stress - thiobarbituric acid reactive substances (TBARS)

  Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.

  3 weeks

• Oxidative stress - ferric-reducing ability of plasma (FRAP)

  Measurement of biomarkers of oxidative stress level. Ferric-reducing ability of plasma (FRAP) - biomarker of plasma antioxidant capacity.

  3 weeks

• Oxidative stress - antioxidative enzymes

  Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.

  3 weeks

• T helper lymphocyte differentiation

  Regulatory T cells (Treg, Foxp3) and Th17 cells will be determined measuring intracellular expression for distinct Th17 markers by using FACS Canto II flow cytometer system.

  3 weeks

• Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration

  Measurement of serum protein concentration (pg/mL) of various pro- and anti-inflammatory cytokines, chemokines, growth factors and soluble cell adhesion molecules by kits and panels for multiplex protein quantitation using the Luminex 200 instrument platform.

  3 weeks

• Endothelial cell activation

  Measurement of serum protein concentration of cell adhesion molecules (e.g. intercellular adhesion molecule 1 - ICAM-1, vascular cell adhesion protein 1 - VCAM-1, and E-selectin) by commercially available ELISA kits, or by multiplex assay kits for the Luminex platform (Luminex® 100/200™ System).

  3 weeks

Secondary Outcomes (4)

• Blood pressure

  3 weeks

• Serum lipid profile

  3 weeks

• Body composition

  3 weeks

• Body fluid status

  3 weeks

Study Arms (2)

QUARTET®

EXPERIMENTAL

Consumption of three QUARTET® (n-3 PUFA, selenium, vitamin E, lutein enriched) hen eggs per day for three weeks

Dietary Supplement: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein)

Control

EXPERIMENTAL

Consumption of three regular hen eggs per day for three weeks

Dietary Supplement: Regular hen eggs

Interventions

QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) DIETARY_SUPPLEMENT

Consumption of three QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) per day for three weeks

QUARTET®

Regular hen eggs DIETARY_SUPPLEMENT

Consumption of three regular hen eggs per day for three weeks

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers (sedentary)
• healthy volunteers (athletes)
• cardiac patients (patients with acute myocardial infarction, hypertensive patients with/without hypertensive heart disease, heart failure patients)

You may not qualify if:

• oral contraceptives
• drugs that could affect endothelium
• hypertension
• coronary artery disease
• diabetes
• hyperlipidaemia
• renal impairment
• cerebrovascular and peripheral artery disease
• known malignant disease
• hereditary metabolic diseases and other hereditary systemic diseases
• autoimmune diseases or systemic diseases with immunopathology
• unregulated hypertension
• recent surgery (3 months)
• recent significant trauma (6 months)
• renal insufficiency (except in diabetic patients unless Endogenous Creatinine Clearance \> 60ml / min)

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek

Osijek, 31000, Croatia

Location

Related Publications (4)

• Stupin A, Rasic L, Matic A, Stupin M, Kralik Z, Kralik G, Grcevic M, Drenjancevic I. Omega-3 polyunsaturated fatty acids-enriched hen eggs consumption enhances microvascular reactivity in young healthy individuals. Appl Physiol Nutr Metab. 2018 Oct;43(10):988-995. doi: 10.1139/apnm-2017-0735. Epub 2018 Apr 10.

  PMID: 29633621 BACKGROUND

• Stupin M, Kibel A, Stupin A, Selthofer-Relatic K, Matic A, Mihalj M, Mihaljevic Z, Jukic I, Drenjancevic I. The Physiological Effect of n-3 Polyunsaturated Fatty Acids (n-3 PUFAs) Intake and Exercise on Hemorheology, Microvascular Function, and Physical Performance in Health and Cardiovascular Diseases; Is There an Interaction of Exercise and Dietary n-3 PUFA Intake? Front Physiol. 2019 Aug 30;10:1129. doi: 10.3389/fphys.2019.01129. eCollection 2019.

  PMID: 31543828 BACKGROUND

• Stupin A, Mihalj M, Kolobaric N, Susnjara P, Kolar L, Mihaljevic Z, Matic A, Stupin M, Jukic I, Kralik Z, Grcevic M, Kralik G, Seric V, Drenjancevic I. Anti-Inflammatory Potential of n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption in Improving Microvascular Endothelial Function of Healthy Individuals-Clinical Trial. Int J Mol Sci. 2020 Jun 10;21(11):4149. doi: 10.3390/ijms21114149.

  PMID: 32532035 BACKGROUND

• Susnjara P, Kolobaric N, Matic A, Mihaljevic Z, Stupin A, Marczi S, Drenjancevic I. Consumption of Hen Eggs Enriched with n-3 Polyunsaturated Fatty Acids, Selenium, Vitamin E and Lutein Incites Anti-Inflammatory Conditions in Young, Healthy Participants - A Randomized Study. Front Biosci (Landmark Ed). 2022 Dec 27;27(12):332. doi: 10.31083/j.fbl2712332.

  PMID: 36624951 DERIVED

MeSH Terms

Interventions

Fatty Acids, Omega-3; Selenium; Vitamin E; Lutein

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Chalcogens; Elements; Inorganic Chemicals; Minerals; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Ines Drenjancevic, MD, PhD

CONTACT

+385912241406; ines.drenjancevic@mefos.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Scientific center of excellence for personalized health care

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: September 25, 2020
• Study Start: October 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)