Enriched QUARTET® Hen Eggs and Cardiovascular Function

NCT ID: NCT04564690

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

QUARTET®

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Control

Consumption of three regular hen eggs per day for three weeks

Group Type: EXPERIMENTAL

Regular hen eggs

Intervention Type: DIETARY_SUPPLEMENT

Consumption of three regular hen eggs per day for three weeks

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Regular hen eggs

Consumption of three regular hen eggs per day for three weeks

Intervention Type: DIETARY_SUPPLEMENT

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

• oral contraceptives
• drugs that could affect endothelium
• hypertension
• coronary artery disease
• diabetes
• hyperlipidaemia
• renal impairment
• cerebrovascular and peripheral artery disease

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: lead

Responsible Party

Ines Drenjancevic

Head of Scientific center of excellence for personalized health care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek

Osijek, , Croatia

Countries

Croatia

Central Contacts

Ines Drenjancevic, MD, PhD

Role: CONTACT

ines.drenjancevic@mefos.hr

+385912241406

Facility Contacts

Ines Drenjancevic, MD, PhD

Role: primary

ines.drenjancevic@mefos.hr

+385912241406

References

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.

Reference Type: BACKGROUND

PMID: 29633621 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31543828 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32532035 (View on PubMed)

Susnjara P, Kolobaric N, Matic A, Mihaljevic Z, Stupin A, Marczi S, Drenjancevic I. Consumption of Hen Eggs Enriched with n-3 Polyunsaturated Fatty Acids, Selenium, Vitamin E and Lutein Incites Anti-Inflammatory Conditions in Young, Healthy Participants - A Randomized Study. Front Biosci (Landmark Ed). 2022 Dec 27;27(12):332. doi: 10.31083/j.fbl2712332.

Reference Type: DERIVED

PMID: 36624951 (View on PubMed)

Other Identifiers

#KK.01.1.1.01.0010

Identifier Type: -

Identifier Source: org_study_id