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

n-3 Polyunsaturated Fatty Acids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725486
• Other study ID #: 2158614622108
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Ines Drenjancevic
• Phone: +385-31-51-28-00
• Email: ines.drenjancevic[@]mefos.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• n-3 Polyunsaturated Fatty Acids

Intervention

Dietary Supplement:
• N-3 PUFAs Chicken Meet
Intake of n-3 PUFAs enriched chicken meet for three weeks.
• Regular Chicken Meet
Intake of regular chicken meet for three weeks.

Locations

Country	Name	City	State
Croatia	Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Macrovascular endothelial function	Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound.	3 weeks
Primary	Cerebrovascular reactivity	Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD).	3 weeks
Secondary	Lipid profile	Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.	3 weeks
Secondary	Oxidative stress status	Measurement of Thiobarbituric Acid Reactive Substances (TBARS).	3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Oxidative stress status	Measurement of Ferric-Reducing Ability of Plasma (FRAP).	3 weeks
Secondary	Oxidative stress status	Measurement of enzyme activity assay of glutathione peroxidase (GPx).	3 weeks