Enriched QUARTET® Hen Eggs and Cardiovascular Function

September 21, 2020 updated by: Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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)
3 weeks
Macrovascular reactivity - FMD of brachial artery
Time Frame: 3 weeks
Flow mediated dilation (FMD) of brachial artery measured by ultrasound.
3 weeks
Macrovascular reactivity - TCD of cerebral blood vessels
Time Frame: 3 weeks
Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).
3 weeks
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.
3 weeks
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.
3 weeks
Oxidative stress - antioxidative enzymes
Time Frame: 3 weeks
Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.
3 weeks
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.
3 weeks
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).
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
3 weeks
Blood pressure
Time Frame: 3 weeks
Measurement of systolic and diastolic blood pressure.
3 weeks
Serum lipid profile
Time Frame: 3 weeks
Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol
3 weeks
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).
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Josip Juraj Strossmayer University of Osijek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #KK.01.1.1.01.0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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