n-3 Polyunsaturated Fatty AcidsNCT04564690
Enriched QUARTET® Hen Eggs and Cardiovascular Function
A study testing QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) and Regular hen eggs in people with n-3 Polyunsaturated Fatty Acids and Selenium, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- n-3 Polyunsaturated Fatty Acids, Selenium, Vitamin E
- What is being tested?
- QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) and Regular hen eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers (sedentary)
- healthy volunteers (athletes)
- cardiac patients (patients with acute myocardial infarction, hypertensive patients with/without hypertensive heart disease, heart failure patients)
Who cannot join
- oral contraceptives
- drugs that could affect endothelium
- hypertension
- coronary artery disease
- diabetes
- hyperlipidaemia
Show all 26Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek
Osijek, 31000
Ines Drenjancevic, MD, PhD, +385912241406, ines.drenjancevic@mefos.hr
About this study
Official title: 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.
- Conditions
- n-3 Polyunsaturated Fatty Acids, Selenium, Vitamin E, Lutein
- Being tested
- QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein), Regular hen eggs
- Keywords
- n-3 polyunsaturated fatty acids, selenium, vitamin E, lutein, vascular function, endothelium, cardiovascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein)Dietary supplement
Consumption of three QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) per day for three weeks
Regular hen eggsDietary supplement
Consumption of three regular hen eggs per day for three weeks
| Study group | Role | What they receive |
|---|---|---|
| QUARTET® | Experimental | Consumption of three QUARTET® (n-3 PUFA, selenium, vitamin E, lutein enriched) hen eggs per day for three weeks Receives: Dietary Supplement: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) |
| Control | Experimental | Consumption of three regular hen eggs per day for three weeks Receives: Dietary Supplement: Regular hen eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular reactivity
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)
Measured: 3 weeks
Macrovascular reactivity - FMD of brachial artery
Flow mediated dilation (FMD) of brachial artery measured by ultrasound.
Measured: 3 weeks
Macrovascular reactivity - TCD of cerebral blood vessels
Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).
Measured: 3 weeks
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
Measured: 3 weeks
Oxidative stress - ferric-reducing ability of plasma (FRAP)
Measurement of biomarkers of oxidative stress level. Ferric-reducing ability of plasma (FRAP) - biomarker of plasma antioxidant capacity.
Measured: 3 weeks
Oxidative stress - antioxidative enzymes
Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.
Measured: 3 weeks
T helper lymphocyte differentiation
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.
Measured: 3 weeks
Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration
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.
Measured: 3 weeks
Endothelial cell activation
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).
Measured: 3 weeks
Secondary outcomes (4)
Blood pressure
Measurement of systolic and diastolic blood pressure.
Measured: 3 weeks
Serum lipid profile
Total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol
Measured: 3 weeks
Body composition
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).
Measured: 3 weeks
Body fluid status
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).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for n-3 Polyunsaturated Fatty AcidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564690
- Sponsor's protocol ID
- #KK.01.1.1.01.0010
- Status last verified
- Sep 2020
- First submitted
- 2 Jul 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29633621Stupin 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.
PubMed 31543828Stupin 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.
PubMed 32532035Susnjara 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.
PubMed 36624951
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enriched QUARTET® Hen Eggs on Cardiovascular Function in Cardiovascular Patients and Healthy Individuals
- ClinicalTrials.gov ID
- NCT04564690
- Acronym / sponsor ID
- #KK.01.1.1.01.0010
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QUARTET® | Experimental | Dietary Supplement: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein)Consumption of three QUARTET® (n-3 PUFA, selenium, vitamin E, lutein enriched) hen eggs per day for three weeks |
| Control | Experimental | Dietary Supplement: Regular hen eggsConsumption of three regular hen eggs per day for three weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy volunteers (sedentary)
- healthy volunteers (athletes)
- cardiac patients (patients with acute myocardial infarction, hypertensive patients with/without hypertensive heart disease, heart failure patients)
Key exclusion criteria (26 listed)
- oral contraceptives
- drugs that could affect endothelium
- hypertension
- coronary artery disease
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | QUARTET® |
| Regular hen eggsConsumption of three regular hen eggs per day for three weeks | Dietary supplement | Control |
Primary outcome
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)
Macrovascular reactivity - FMD of brachial artery
Time frame: 3 weeks
Flow mediated dilation (FMD) of brachial artery measured by ultrasound.
Macrovascular reactivity - TCD of cerebral blood vessels
Time frame: 3 weeks
Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).
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.
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.
Oxidative stress - antioxidative enzymes
Time frame: 3 weeks
Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.
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.
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.
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).
4 secondary outcomes
Blood pressure
Time frame: 3 weeks
Serum lipid profile
Time frame: 3 weeks
Body composition
Time frame: 3 weeks
Body fluid status
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 29633621Stupin 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.
- Background: PubMed 31543828Stupin 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.
- Background: PubMed 32532035Stupin 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.
- Derived from this study: PubMed 36624951Susnjara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) and Regular hen eggs in people with n-3 Polyunsaturated Fatty Acids and Selenium, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines Drenjancevic, MD, PhD (+385912241406, ines.drenjancevic@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular reactivity (time frame: 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564690, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.