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Enriched QUARTET® Hen Eggs and Cardiovascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564690
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ines Drenjancevic, 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.

Condition or disease Intervention/treatment Phase
n-3 Polyunsaturated Fatty Acids Selenium Vitamin E Lutein Dietary Supplement: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) Dietary Supplement: Regular hen eggs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Enriched QUARTET® Hen Eggs on Cardiovascular Function in Cardiovascular Patients and Healthy Individuals
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

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

Experimental: Control
Consumption of three regular hen eggs per day for three weeks
Dietary Supplement: Regular hen eggs
Consumption of three regular hen eggs per day for three weeks




Primary Outcome Measures :
  1. Microvascular reactivity [ Time Frame: 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)

  2. Macrovascular reactivity - FMD of brachial artery [ Time Frame: 3 weeks ]
    Flow mediated dilation (FMD) of brachial artery measured by ultrasound.

  3. Macrovascular reactivity - TCD of cerebral blood vessels [ Time Frame: 3 weeks ]
    Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).

  4. Oxidative stress - thiobarbituric acid reactive substances (TBARS) [ Time Frame: 3 weeks ]
    Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.

  5. Oxidative stress - ferric-reducing ability of plasma (FRAP) [ Time Frame: 3 weeks ]
    Measurement of biomarkers of oxidative stress level. Ferric-reducing ability of plasma (FRAP) - biomarker of plasma antioxidant capacity.

  6. Oxidative stress - antioxidative enzymes [ Time Frame: 3 weeks ]
    Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.

  7. T helper lymphocyte differentiation [ Time Frame: 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.

  8. Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration [ Time Frame: 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.

  9. Endothelial cell activation [ Time Frame: 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).


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 weeks ]
    Measurement of systolic and diastolic blood pressure.

  2. Serum lipid profile [ Time Frame: 3 weeks ]
    Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol

  3. Body composition [ Time Frame: 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).

  4. Body fluid status [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564690


Contacts
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Contact: Ines Drenjancevic, MD, PhD +385912241406 ines.drenjancevic@mefos.hr

Locations
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Croatia
Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek
Osijek, Croatia, 31000
Contact: Ines Drenjancevic, MD, PhD    +385912241406    ines.drenjancevic@mefos.hr   
Sponsors and Collaborators
Josip Juraj Strossmayer University of Osijek
Publications:
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Responsible Party: Ines Drenjancevic, Head of Scientific center of excellence for personalized health care, Josip Juraj Strossmayer University of Osijek
ClinicalTrials.gov Identifier: NCT04564690    
Other Study ID Numbers: #KK.01.1.1.01.0010
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek:
n-3 polyunsaturated fatty acids
selenium
vitamin E
lutein
vascular function
endothelium
cardiovascular health
Additional relevant MeSH terms:
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Vitamin E
Selenium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements