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

Not Applicable

Recruiting

• Conditions: n-3 Polyunsaturated Fatty Acids
• Interventions: Dietary Supplement: Regular Chicken Meet; Dietary Supplement: N-3 PUFAs Chicken Meet

• Registration Number: NCT05725486
• Lead Sponsor: Josip Juraj Strossmayer University of Osijek

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-01-24
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Regular Chicken Meet	Intake of regular chicken meet for three weeks
n-3 PUFA	N-3 PUFAs Chicken Meet	Intake of n-3 PUFAs enriched chicken meet for three weeks

Primary Outcome Measures

Name	Time	Method
Microvascular endothelial function	3 weeks	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).
Cerebrovascular reactivity	3 weeks	Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD).
Macrovascular endothelial function	3 weeks	Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound.

Secondary Outcome Measures

Name	Time	Method
Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration	3 weeks	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.
Lipid profile	3 weeks	Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.
Oxidative stress status	3 weeks	Measurement of enzyme activity assay of glutathione peroxidase (GPx).
Systemic hemodynamics	3 weeks	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).
Body composition	3 weeks	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).
Body fluid status	3 weeks	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).

Trial Locations

Locations (1)

Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek; 🇭🇷 Osijek, Croatia