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

Sponsor
Josip Juraj Strossmayer University of Osijek (Other)
Overall Status
Recruiting
CT.gov ID
NCT05725486
Collaborator
(none)
50
1
2
21.9
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: N-3 PUFAs Chicken Meet
  • Dietary Supplement: Regular Chicken Meet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet on Cardiovascular Function
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Macrovascular endothelial function [3 weeks]

    Measurement of flow mediated dilation (FMD) of brachial artery using ultrasound.

  3. Cerebrovascular reactivity [3 weeks]

    Measurement of cerebrovascular blood flow using transcranial color Doppler (TCD).

Secondary Outcome Measures

  1. Lipid profile [3 weeks]

    Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.

  2. Oxidative stress status [3 weeks]

    Measurement of Thiobarbituric Acid Reactive Substances (TBARS).

  3. 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).

  4. 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.

  5. 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).

  6. 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).

  7. Oxidative stress status [3 weeks]

    Measurement of Ferric-Reducing Ability of Plasma (FRAP).

  8. Oxidative stress status [3 weeks]

    Measurement of enzyme activity assay of glutathione peroxidase (GPx).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossayer University of Osijek Osijek Croatia 31000

Sponsors and Collaborators

  • Josip Juraj Strossmayer University of Osijek

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ines Drenjancevic, Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek, Josip Juraj Strossmayer University of Osijek
ClinicalTrials.gov Identifier:
NCT05725486
Other Study ID Numbers:
  • 2158614622108
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ines Drenjancevic, Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek, Josip Juraj Strossmayer University of Osijek

Study Results

No Results Posted as of Feb 13, 2023