NCT02720250

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 22, 2016

Last Update Submit

March 29, 2016

Conditions

Keywords

omega-3 fatty acids, microcirculation, laser Doppler flowmetry, lipid profile

Outcome Measures

Primary Outcomes (1)

  • 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).

    Three weeks

Secondary Outcomes (1)

  • lipid profile

    Three weeks

Study Arms (2)

Omega-3

EXPERIMENTAL

Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.

Dietary Supplement: Omega-3 chicken eggs

Regular

EXPERIMENTAL

Intake of 3 regular chicken eggs per day for three weeks.

Dietary Supplement: Regular chicken eggs

Interventions

Omega-3 chicken eggsDIETARY_SUPPLEMENT

Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.

Omega-3
Regular chicken eggsDIETARY_SUPPLEMENT

Intake of 3 regular chicken eggs per day for three weeks.

Regular

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- healthy volunteers

You may not qualify if:

  • oral contraceptives
  • drugs that could affect endothelium
  • hypertension
  • coronary artery disease
  • diabetes
  • hyperlipidaemia
  • renal impairment
  • cerebrovascular and peripheral artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology

Osijek, 31000, Croatia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26498129BACKGROUND

Study Officials

  • Ines Drenjancevic, MD, PhD

    Faculty of Medicine, University of Osijek, Croatia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Stupin, MD, PhD

CONTACT

Ines Drenjancevic, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations