Omega-3 Polyunsaturated Fatty AcidsNCT02720250
Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity
A study testing Omega-3 chicken eggs and Regular chicken eggs in people with Omega-3 Polyunsaturated Fatty Acids, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients. However, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Omega-3 Polyunsaturated Fatty Acids
- What is being tested?
- Omega-3 chicken eggs and Regular chicken eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- Mar 2016to Dec 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- oral contraceptives
- drugs that could affect endothelium
- hypertension
- coronary artery disease
- diabetes
- hyperlipidaemia
- renal impairment
- cerebrovascular and peripheral artery disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
Osijek, 31000
Ana Stupin, MD, PhD, '385915134598, anacavka@mefos.hr
Ines Drenjancevic, MD, PhD, '385912241406, ines.drenjancevic@mefos.hr
About this study
Official title: Effect of Omega-3 Fatty Acids Enriched Chicken Eggs Consumption on Microvascular Reactivity and Lipid Profile in Young Healthy Subjects
Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients.
However, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in healthy population.
This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on microvascular reactivity and lipid profile in young healthy subjects.
- Conditions
- Omega-3 Polyunsaturated Fatty Acids
- Being tested
- Omega-3 chicken eggs, Regular chicken eggs
- Keywords
- omega-3 fatty acids, microcirculation, laser Doppler flowmetry, lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 chicken eggsDietary supplement
Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
Regular chicken eggsDietary supplement
Intake of 3 regular chicken eggs per day for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks. Receives: Dietary Supplement: Omega-3 chicken eggs |
| Regular | Experimental | Intake of 3 regular chicken eggs per day for three weeks. Receives: Dietary Supplement: Regular chicken eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
microvascular reactivity
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation).
Measured: Three weeks
Secondary outcomes (1)
lipid profile
Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Omega-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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- Investigators
- Ines Drenjancevic, MD, PhD, Principal investigator, Faculty of Medicine, University of Osijek, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720250
- Sponsor's protocol ID
- 2158610714114
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
PubMed 26498129
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Fatty Acids Enriched Chicken Eggs Consumption on Microvascular Reactivity and Lipid Profile in Young Healthy Subjects
- ClinicalTrials.gov ID
- NCT02720250
- Acronym / sponsor ID
- 2158610714114
- Conditions
- Omega-3 Polyunsaturated Fatty Acids
- Keywords
- omega-3 fatty acids, microcirculation, laser Doppler flowmetry, lipid profile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Mar 2016 (estimated)
- 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.
Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients.
However, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in healthy population.
This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on microvascular reactivity and lipid profile in young healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3 chicken eggsIntake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks. |
| Regular | Experimental | Dietary Supplement: Regular chicken eggsIntake of 3 regular chicken eggs per day for three weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (8 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 |
|---|---|---|
| Omega-3 chicken eggsIntake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks. | Dietary supplement | Omega-3 |
| Regular chicken eggsIntake of 3 regular chicken eggs per day for three weeks. | Dietary supplement | Regular |
Primary outcome
microvascular reactivity
Time frame: Three weeks
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation).
1 secondary outcome
lipid profile
Time frame: Three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Background: PubMed 26498129Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
- Individual participant dataSharing planned: No
Related trials for Omega-3 Polyunsaturated Fatty Acids
Not yet recruiting
Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.
Cardio-pulmonary Bypass, Cardiovascular Diseases
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.
Ines Drenjancevic, MD, PhD principal investigator
Faculty of Medicine, University of Osijek, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 chicken eggs and Regular chicken eggs in people with Omega-3 Polyunsaturated Fatty Acids, 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 1 inclusion and 8 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 30 Mar 2016. 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 Ana Stupin, MD, PhD (+385915134958, anacavka@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: Three weeks). 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 NCT02720250, which also lists 1 linked publication.
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 30 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.