Enriched QUARTET® Hen Eggs and Cardiovascular Function

Josip Juraj Strossmayer University of Osijek

Status: Unknown

Conditions: Lutein; n-3 Polyunsaturated Fatty Acids; Selenium; Vitamin E

Treatments: Dietary Supplement: Regular hen eggs; Dietary Supplement: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein)

Study type: Interventional

Funder types: Other

Identifiers

NCT04564690

#KK.01.1.1.01.0010

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

QUARTET®

Experimental group

Description:

Consumption of three QUARTET® (n-3 PUFA, selenium, vitamin E, lutein enriched) hen eggs per day for three weeks

Treatment:

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

Control

Experimental group

Description:

Consumption of three regular hen eggs per day for three weeks

Treatment:

Dietary Supplement: Regular hen eggs