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
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 30, 2016
March 1, 2016
1.8 years
March 22, 2016
March 29, 2016
Conditions
Keywords
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
EXPERIMENTALIntake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
Regular
EXPERIMENTALIntake of 3 regular chicken eggs per day for three weeks.
Interventions
Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
Intake of 3 regular chicken eggs per day for three weeks.
Eligibility Criteria
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
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
- PRINCIPAL INVESTIGATOR
Ines Drenjancevic, MD, PhD
Faculty of Medicine, University of Osijek, Croatia
Central Study Contacts
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