Enriched QUARTET® Hen Eggs and Cardiovascular Function

Not Applicable

• Conditions: n-3 Polyunsaturated Fatty Acids; Selenium; Vitamin E; Lutein
• Interventions: Dietary Supplement: Regular hen eggs; Dietary Supplement: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein)

• Registration Number: NCT04564690
• Lead Sponsor: Josip Juraj Strossmayer University of Osijek

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-02
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25
• Study Start: 2020-10-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria for Healthy Volunteers:

• oral contraceptives
• drugs that could affect endothelium
• hypertension
• coronary artery disease
• diabetes
• hyperlipidaemia
• renal impairment
• cerebrovascular and peripheral artery disease

Exclusion Criteria for Cardiac Patients:

• 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)
• active bleeding (hematuria, GI tract, menorrhagia)
• fresh ICV (6 weeks)
• neurodegenerative diseases and epilepsy
• significant anemia (Hg <110 (men), <100 (women))
• condition after resuscitation (3 months)
• therapy that significantly affects vascular or immune function (monoclonal antibodies, immunosuppressants, systemic corticosteroids ...)
• chronic respiratory failure and conditions of chronic hypoxemia
• sepsis and chronic active infections with systemic inflammatory response (active tuberculosis, etc.)
• untreated thyroid disease
• active abuse of alcohol and drugs
• liver failure (advanced liver disease with impaired synthetic and metabolic function)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
T helper lymphocyte differentiation	3 weeks	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.
Endothelial cell activation	3 weeks	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).
Microvascular reactivity	3 weeks	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)
Macrovascular reactivity - FMD of brachial artery	3 weeks	Flow mediated dilation (FMD) of brachial artery measured by ultrasound.
Macrovascular reactivity - TCD of cerebral blood vessels	3 weeks	Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).
Oxidative stress - thiobarbituric acid reactive substances (TBARS)	3 weeks	Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
Oxidative stress - antioxidative enzymes	3 weeks	Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.
Oxidative stress - ferric-reducing ability of plasma (FRAP)	3 weeks	Measurement of biomarkers of oxidative stress level. Ferric-reducing ability of plasma (FRAP) - biomarker of plasma antioxidant capacity.
Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	3 weeks	Measurement of systolic and diastolic blood pressure.
Serum lipid profile	3 weeks	Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol
Body composition	3 weeks	Body composition and body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg).
Body fluid status	3 weeks	Body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L) and Body Density (kg/L).

Trial Locations

Locations (1)

Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek; 🇭🇷 Osijek, Croatia