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

NCT05725486 | Unknown

• 1 other identifier: 2158614622108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

n-3 Polyunsaturated Fatty Acids

Keywords

n-3 polyunsaturated fatty acids; vascular function; endothelium; oxidative stress; inflammation; microcircularion; macrocirculation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Lipid profile

  3 weeks

• Oxidative stress status

  3 weeks

• Systemic hemodynamics

  3 weeks

• Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration

  3 weeks

• Body composition

  3 weeks

Study Arms (2)

n-3 PUFA

EXPERIMENTAL

Intake of n-3 PUFAs enriched chicken meet for three weeks

Dietary Supplement: N-3 PUFAs Chicken Meet

Control

EXPERIMENTAL

Intake of regular chicken meet for three weeks

Dietary Supplement: Regular Chicken Meet

Interventions

N-3 PUFAs Chicken Meet DIETARY_SUPPLEMENT

Intake of n-3 PUFAs enriched chicken meet for three weeks.

n-3 PUFA

Regular Chicken Meet DIETARY_SUPPLEMENT

Intake of regular chicken meet for three weeks.

Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek

Osijek, 31000, Croatia

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ines Drenjancevic

CONTACT

+385-31-51-28-00; ines.drenjancevic@mefos.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• 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: January 24, 2023
• First Posted: February 13, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

CR (1)