Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity

Omega-3 Polyunsaturated Fatty Acids Clinical Trial

Official title:

Effect of Omega-3 Fatty Acids Enriched Chicken Eggs Consumption on Microvascular Reactivity and Lipid Profile in Young Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02720250
• Other study ID #: 2158610714114
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: March 29, 2016
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Ana Stupin, MD, PhD
• Phone: +385915134958
• Email: anacavka[@]mefos.hr
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Science, Education and Sports
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Omega-3 Polyunsaturated Fatty Acids

Intervention

Dietary Supplement:
• Omega-3 chicken eggs
Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
• Regular chicken eggs
Intake of 3 regular chicken eggs per day for three weeks.

Locations

Country	Name	City	State
Croatia	Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	lipid profile	Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.	Three weeks	No