- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04564690
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
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- 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
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Osijek, Croatia, 31000
- Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek
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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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: QUARTET®
Consumption of three QUARTET® (n-3 PUFA, selenium, vitamin E, lutein enriched) hen eggs per day for three weeks
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Consumption of three QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) per day for three weeks
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EXPERIMENTAL: Control
Consumption of three regular hen eggs per day for three weeks
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Consumption of three regular hen eggs per day for three weeks
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What is the study measuring?
Primary Outcome Measures
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
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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.
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3 weeks
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Microvascular reactivity
Time Frame: 3 weeks
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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)
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3 weeks
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Macrovascular reactivity - FMD of brachial artery
Time Frame: 3 weeks
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Flow mediated dilation (FMD) of brachial artery measured by ultrasound.
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3 weeks
|
Macrovascular reactivity - TCD of cerebral blood vessels
Time Frame: 3 weeks
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Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).
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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.
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3 weeks
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Oxidative stress - ferric-reducing ability of plasma (FRAP)
Time Frame: 3 weeks
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Measurement of biomarkers of oxidative stress level.
Ferric-reducing ability of plasma (FRAP) - biomarker of plasma antioxidant capacity.
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3 weeks
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Oxidative stress - antioxidative enzymes
Time Frame: 3 weeks
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Measurement of biomarkers of oxidative stress level.
Plasma concentration of antioxidative enzymes.
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3 weeks
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T helper lymphocyte differentiation
Time Frame: 3 weeks
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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.
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3 weeks
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Endothelial cell activation
Time Frame: 3 weeks
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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).
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: 3 weeks
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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).
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3 weeks
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Blood pressure
Time Frame: 3 weeks
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Measurement of systolic and diastolic blood pressure.
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3 weeks
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Serum lipid profile
Time Frame: 3 weeks
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Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol
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3 weeks
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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).
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3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- 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.
- 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.
- 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.
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)
October 1, 2020
Primary Completion (ANTICIPATED)
July 1, 2022
Study Completion (ANTICIPATED)
July 1, 2022
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
September 21, 2020
First Posted (ACTUAL)
September 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2020
Last Update Submitted That Met QC Criteria
September 21, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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