Clinical trial NCT04564690: Enriched QUARTET® Hen Eggs and Cardiovascular Function
Official title: Effect of Enriched QUARTET® Hen Eggs on Cardiovascular Function in Cardiovascular Patients and Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Microvascular reactivity
timeFrame: 3 weeks
measure: Macrovascular reactivity - FMD of brachial artery
timeFrame: 3 weeks
measure: Macrovascular reactivity - TCD of cerebral blood vessels
timeFrame: 3 weeks
measure: Oxidative stress - thiobarbituric acid reactive substances (TBARS)
timeFrame: 3 weeks
measure: Oxidative stress - ferric-reducing ability of plasma (FRAP)
timeFrame: 3 weeks
measure: Oxidative stress - antioxidative enzymes
timeFrame: 3 weeks
measure: T helper lymphocyte differentiation
timeFrame: 3 weeks
measure: Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration
timeFrame: 3 weeks
measure: Endothelial cell activation
timeFrame: 3 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 weeks
measure: Serum lipid profile
timeFrame: 3 weeks
measure: Body composition
timeFrame: 3 weeks
measure: Body fluid status
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek
Study officials:
References:
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.
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.
citation: 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.