Enriched QUARTET® Hen Eggs and Cardiovascular Function

Selenium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04564690
• Other study ID #: #KK.01.1.1.01.0010
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2020
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Ines Drenjancevic, MD, PhD
• Phone: +385912241406
• Email: ines.drenjancevic[@]mefos.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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
• Regular hen eggs
Consumption of three regular hen eggs per day for three weeks

Locations

Country	Name	City	State
Croatia	Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

References & Publications (3)

Stupin A, Mihalj M, Kolobaric N, Šušnjara P, Kolar L, Mihaljevic Z, Matic A, Stupin M, Jukic I, Kralik Z, Grcevic M, Kralik G, Šeric 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). pii: E4149. doi: 10.3390/ijms21114149. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Macrovascular reactivity - FMD of brachial artery	Flow mediated dilation (FMD) of brachial artery measured by ultrasound.	3 weeks
Primary	Macrovascular reactivity - TCD of cerebral blood vessels	Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).	3 weeks
Primary	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
Primary	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
Primary	Oxidative stress - antioxidative enzymes	Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.	3 weeks
Primary	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
Primary	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
Primary	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	Blood pressure	Measurement of systolic and diastolic blood pressure.	3 weeks
Secondary	Serum lipid profile	Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol	3 weeks
Secondary	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
Secondary	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