n-3 Polyunsaturated Fatty AcidsNCT05725486
N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet and Cardiovascular Function
A study testing N-3 PUFAs Chicken Meet and Regular Chicken Meet in people with n-3 Polyunsaturated Fatty Acids, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
Evidence from multiple experimental, epidemiological, and clinical studies indicate that n-3 polyunsaturated fatty acids (n-3 PUFAs) may exert their cardiovascular (CV) protective effect, at least in part, by improving vascular endothelium-dependent function. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- n-3 Polyunsaturated Fatty Acids
- What is being tested?
- N-3 PUFAs Chicken Meet and Regular Chicken Meet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2022to 30 Jun 2024
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study
- young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study
Who cannot join
- smoking
- hypertension
- coronary disease
- diabetes
- hyperlipidemia
- kidney damage
- cerebrovascular and peripheral artery diseases
- and any other disease that could have an impact on vascular and endothelial function
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek
Osijek, 31000
Ivana Jukić, MD, PhD, ivana.jukic@mefos.hr
About this study
Official title: Effects of N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet on Cardiovascular Function
Evidence from multiple experimental, epidemiological, and clinical studies indicate that n-3 polyunsaturated fatty acids (n-3 PUFAs) may exert their cardiovascular (CV) protective effect, at least in part, by improving vascular endothelium-dependent function. Previously, the investigators demonstrated the significant beneficiary effect of consumption of n-3 PUFA-enriched hen eggs on microvascular endothelium-dependent reactivity, even in young healthy individuals.
The hypothesis of this research is that the consumption of n-3 PUFAs in the form of functionally enriched chicken meet has a beneficial effect on vascular reactivity measured in different vascular beds, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary individuals.
The main goal of this study is to investigate the influence of n-3 PUFAs functionally enriched chicken meet on vascular and endothelial function in a population of healthy young subjects and active athletes.
- Conditions
- n-3 Polyunsaturated Fatty Acids
- Being tested
- N-3 PUFAs Chicken Meet, Regular Chicken Meet
- Keywords
- n-3 polyunsaturated fatty acids, vascular function, endothelium, oxidative stress, inflammation, microcircularion, macrocirculation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-3 PUFAs Chicken MeetDietary supplement
Intake of n-3 PUFAs enriched chicken meet for three weeks.
Regular Chicken MeetDietary supplement
Intake of regular chicken meet for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFA | Experimental | Intake of n-3 PUFAs enriched chicken meet for three weeks Receives: Dietary Supplement: N-3 PUFAs Chicken Meet |
| Control | Experimental | Intake of regular chicken meet for three weeks Receives: Dietary Supplement: Regular Chicken Meet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular endothelial function
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH).
Measured: 3 weeks
Macrovascular endothelial function
Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound.
Measured: 3 weeks
Cerebrovascular reactivity
Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD).
Measured: 3 weeks
Secondary outcomes (8)
Lipid profile
Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.
Measured: 3 weeks
Oxidative stress status
Measurement of Thiobarbituric Acid Reactive Substances (TBARS).
Measured: 3 weeks
Systemic hemodynamics
Non-invasive assessment of systemic hemodynamics using impedance cardiography (CardioScreen 2000) - SV Stroke Volume (mL), CO Cardiac Output (L/min) and SVRI Systemic Vascular Resistance Index (dyn.s.cm-5 m2).
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
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).
Measured: 3 weeks
Oxidative stress status
Measurement of Ferric-Reducing Ability of Plasma (FRAP).
Measured: 3 weeks
Oxidative stress status
Measurement of enzyme activity assay of glutathione peroxidase (GPx).
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 posted13 Feb 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725486
- Sponsor's protocol ID
- 2158614622108
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nad T, Kos M, Stupin A, Drenjancevic I, Kolobaric N, Mihaljevic Z, Susnjara P, Damasek M, Kardum D, Jukic I. Improving Endothelium-Dependent Vasodilation with Dietary Intake of n-3 Polyunsaturated Fatty Acids-Enriched Chicken Meat: A Randomized Controlled Trial. Biomedicines. 2026 Apr 8;14(4):852. doi: 10.3390/biomedicines14040852.
PubMed 42072392
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet on Cardiovascular Function
- ClinicalTrials.gov ID
- NCT05725486
- Acronym / sponsor ID
- 2158614622108
- Conditions
- n-3 Polyunsaturated Fatty Acids
- Keywords
- n-3 polyunsaturated fatty acids, vascular function, endothelium, oxidative stress, inflammation, microcircularion, macrocirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
Evidence from multiple experimental, epidemiological, and clinical studies indicate that n-3 polyunsaturated fatty acids (n-3 PUFAs) may exert their cardiovascular (CV) protective effect, at least in part, by improving vascular endothelium-dependent function. Previously, the investigators demonstrated the significant beneficiary effect of consumption of n-3 PUFA-enriched hen eggs on microvascular endothelium-dependent reactivity, even in young healthy individuals.
The hypothesis of this research is that the consumption of n-3 PUFAs in the form of functionally enriched chicken meet has a beneficial effect on vascular reactivity measured in different vascular beds, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary individuals.
The main goal of this study is to investigate the influence of n-3 PUFAs functionally enriched chicken meet on vascular and endothelial function in a population of healthy young subjects and active athletes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA | Experimental | Dietary Supplement: N-3 PUFAs Chicken MeetIntake of n-3 PUFAs enriched chicken meet for three weeks |
| Control | Experimental | Dietary Supplement: Regular Chicken MeetIntake of regular chicken meet for three weeks |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study
- young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study
Key exclusion criteria (8 listed)
- smoking
- hypertension
- coronary disease
- diabetes
- hyperlipidemia
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 |
|---|---|---|
| N-3 PUFAs Chicken MeetIntake of n-3 PUFAs enriched chicken meet for three weeks. | Dietary supplement | n-3 PUFA |
| Regular Chicken MeetIntake of regular chicken meet for three weeks. | Dietary supplement | Control |
Primary outcome
Microvascular endothelial function
Time frame: 3 weeks
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH).
Macrovascular endothelial function
Time frame: 3 weeks
Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound.
Cerebrovascular reactivity
Time frame: 3 weeks
Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD).
8 secondary outcomes
Lipid profile
Time frame: 3 weeks
Oxidative stress status
Time frame: 3 weeks
Systemic hemodynamics
Time frame: 3 weeks
Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration
Time frame: 3 weeks
Body composition
Time frame: 3 weeks
Body fluid status
Time frame: 3 weeks
Oxidative stress status
Time frame: 3 weeks
Oxidative stress 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 13 Feb 2023.
- Derived from this study: PubMed 42072392Nad T, Kos M, Stupin A, Drenjancevic I, Kolobaric N, Mihaljevic Z, Susnjara P, Damasek M, Kardum D, Jukic I. Improving Endothelium-Dependent Vasodilation with Dietary Intake of n-3 Polyunsaturated Fatty Acids-Enriched Chicken Meat: A Randomized Controlled Trial. Biomedicines. 2026 Apr 8;14(4):852. doi: 10.3390/biomedicines14040852.
- Individual participant dataSharing planned: Undecided
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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 N-3 PUFAs Chicken Meet and Regular Chicken Meet in people with n-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 2 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 13 Feb 2023. 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 (+385-31-51-28-00, 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 endothelial function (time frame: 3 weeks). The study lists 3 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 NCT05725486, 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 13 Feb 2023.