N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet and Cardiovascular Function

Effects of N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet on Cardiovascular Function

Evidence from multiple experimental, epidemiological, and clinical studies indicate that n-3 polyunsaturated fatty acids (n-3 PUFAs) may exert their cardiovascular (CV) protective effect, at least in part, by improving vascular endothelium-dependent function. Previously, the investigators demonstrated the significant beneficiary effect of consumption of n-3 PUFA-enriched hen eggs on microvascular endothelium-dependent reactivity, even in young healthy individuals.

The hypothesis of this research is that the consumption of n-3 PUFAs in the form of functionally enriched chicken meet has a beneficial effect on vascular reactivity measured in different vascular beds, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary individuals.

The main goal of this study is to investigate the influence of n-3 PUFAs functionally enriched chicken meet on vascular and endothelial function in a population of healthy young subjects and active athletes.

Study Overview

• Status: Recruiting
• Conditions: n-3 Polyunsaturated Fatty Acids
• Intervention / Treatment: Dietary supplement: N-3 PUFAs Chicken Meet; Dietary supplement: Regular Chicken Meet

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ines Drenjancevic; Phone Number: +385-31-51-28-00; Email: ines.drenjancevic@mefos.hr

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Recruiting
    • Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek
    • Contact: Ivana Jukić, MD, PhD; Email: ivana.jukic@mefos.hr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study
• young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study

Exclusion Criteria:

• smoking
• hypertension
• coronary disease
• diabetes
• hyperlipidemia
• kidney damage
• cerebrovascular and peripheral artery diseases
• and any other disease that could have an impact on vascular and endothelial function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: n-3 PUFA; Intake of n-3 PUFAs enriched chicken meet for three weeks	Dietary supplement: N-3 PUFAs Chicken Meet; Intake of n-3 PUFAs enriched chicken meet for three weeks.
EXPERIMENTAL: Control; Intake of regular chicken meet for three weeks	Dietary supplement: Regular Chicken Meet; Intake of regular chicken meet for three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular endothelial function	Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH).	3 weeks
Macrovascular endothelial function	Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound.	3 weeks
Cerebrovascular reactivity	Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD).	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.	3 weeks
Oxidative stress status	Measurement of Thiobarbituric Acid Reactive Substances (TBARS).	3 weeks
Systemic hemodynamics	Non-invasive assessment of systemic hemodynamics using impedance cardiography (CardioScreen 2000) - SV Stroke Volume (mL), CO Cardiac Output (L/min) and SVRI Systemic Vascular Resistance Index (dyn.s.cm-5 m2).	3 weeks
Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration	Measurement of serum protein concentration (pg/mL) of various pro- and anti-inflammatory cytokines, chemokines, growth factors and soluble cell adhesion molecules by kits and panels for multiplex protein quantitation using the Luminex 200 instrument platform.	3 weeks
Body composition	Body composition and body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg).	3 weeks
Body fluid status	Body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L).	3 weeks
Oxidative stress status	Measurement of Ferric-Reducing Ability of Plasma (FRAP).	3 weeks
Oxidative stress status	Measurement of enzyme activity assay of glutathione peroxidase (GPx).	3 weeks

Collaborators and Investigators

• Sponsor: Josip Juraj Strossmayer University of Osijek

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: n-3 polyunsaturated fatty acids; inflammation; vascular function; oxidative stress; endothelium; macrocirculation; microcircularion
• Other Study ID Numbers: 2158614622108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No