- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02720250
Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ana Stupin, MD, PhD
- Phone Number: +385915134958
- Email: anacavka@mefos.hr
Study Locations
-
-
-
Osijek, Croatia, 31000
- Recruiting
- Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
-
Contact:
- Ana Stupin, MD, PhD
- Phone Number: '385915134598
- Email: anacavka@mefos.hr
-
Contact:
- Ines Drenjancevic, MD, PhD
- Phone Number: '385912241406
- Email: ines.drenjancevic@mefos.hr
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Sub-Investigator:
- Marko Stupin, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- oral contraceptives
- drugs that could affect endothelium
- hypertension
- coronary artery disease
- diabetes
- hyperlipidaemia
- renal impairment
- cerebrovascular and peripheral artery disease
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3
Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
|
Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
|
Experimental: Regular
Intake of 3 regular chicken eggs per day for three weeks.
|
Intake of 3 regular chicken eggs per day for three weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Three weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lipid profile
Time Frame: Three weeks
|
Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.
|
Three weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ines Drenjancevic, MD, PhD, Faculty of Medicine, University of Osijek, Croatia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2158610714114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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