Enriched QUARTET® Hen Eggs and Cardiovascular Function

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Enriched QUARTET® Hen Eggs on Cardiovascular Function in Cardiovascular Patients and Healthy Individuals

Conditions
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Lutein, n-3 Polyunsaturated Fatty Acids, Selenium, Vitamin E

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QUARTET®<br>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)<br>* Consumption of three QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) per day for three weeks<br>|
| Experimental: Control<br>Consumption of three regular hen eggs per day for three weeks | Dietary Supplement: Regular hen eggs<br>* Consumption of three regular hen eggs per day for three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measurement of systolic and diastolic blood pressure. | 3 weeks | 
| Serum lipid profile | Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol | 3 weeks | 
| Body composition | 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). | 3 weeks | 
| Body fluid status | 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). | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3 polyunsaturated fatty acids, selenium, vitamin E, lutein, vascular function, endothelium, cardiovascular health