Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity

March 29, 2016 updated by: Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek

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

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

Study Locations

      • Osijek, Croatia, 31000
        • Recruiting
        • Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Marko Stupin, MD

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

  • 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ines Drenjancevic, MD, PhD, Faculty of Medicine, University of Osijek, Croatia

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.

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

March 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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