Skip to main content
OpenTrials
Completed

NCT Number: NCT05502172

Effects of Nutritional Intervention With Fish-derived Lipids in Improving Antiviral Immunity

The aim of the study is to evaluate the effects of fish-derived lipids on antiviral immunity in healthy individuals. The study will be conducted on a group of 30 healthy volunteers recruited at the Department of Periodontology and Oral Diseases of the Medical University of Lodz. These people will take a composition of fish-derived oils (BioMarine®Medical Immuno & Neuro Lipids) at a dose of 0.5 ml / kg body weight per day in two / three divided doses for 90 days. BioMarine®Medical Immuno & Neuro Lipids is food for special medical purposes. At baseline and after 90 days, blood samples will be taken from the test subjects in order to evaluate the selected parameters of antiviral immunity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral Diseases

Lodz, 92-213, Poland

About this study

The proposed clinical trial involving a nutritional intervention aims to assess the effect of a composition of fish oils containing, inter alia, WWKT omega-3 EPA and DHA, alkylglycerols and squalene on selected parameters of antiviral immunity in healthy people. The proposed daily dose of BioMarine®Medical Immuno & Neuro Lipids is 0.5 ml / kg b.w., which in practice for a person weighing 60 kg will mean a daily consumption of 30 mL of oil (including 1.6 g EPA, 9.1 g DHA, 2 5 g of alkylglycerols and 2.6 g of squalene).

At baseline, 15 ml of blood will be drawn in order to determine the parameters of the antiviral response.

The following immunological parameters will be tested:

  • NK cell activity using a mixed culture of PBMC with target cells (ability to inhibit tumor cell proliferation) assessed by flow cytometry.
  • Absolute number and percentage of NK cells (CD16 + CD56 +), cytotoxic (CD8 +), helper (CD4 +) lymphocytes, B (CD19 +) lymphocytes in the total pool of peripheral blood mononuclear cells (PBMC) by flow cytometry.
  • Ability of isolated PBMCs to synthesize INF-α, INF-β, INF-γ, IL-6 and TNF without and after polyclonal stimulation (PHA) and SARS-CoV-2 proteins (nucleocapside protein, SARS-CoV-2 spike protein ) in 42 h culture based on the determination of the level of protein released into the culture fluid and on the basis of mRNA expression for these factors. Analysis of PBMC post-culture supernatants (CBA technique with flow cytometer and gene expression analysis by qPCR).
  • Analysis of the composition of serum lipids and in PBMC lyophilisates after culture.

Blood sampling will be repeated after 90 days in order to determine the influence of the fish oils on the tested parameters.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • absence of systemic diseases;
  • no medications taken on a regular basis;
  • correct body weight in relation to height - 18.5 ≤ BMI ≤ 24.9

Exclusion criteria

  • lack of consent the patient'sto the examination.
  • pregnant and lactating women;
  • smokers or non-smokers for less than 5 years;
  • any vaccinations in the period shorter than 1 month before the start of the study or planned during the study;
  • lack of declaration on reducing fats in the diet and avoiding highly processed fats and fried products.

Treatment and study plan

Fish Oil

Dietary Supplement

healthy individuals will be taking the composition of fish-deraivd oils BioMarine®Medical Immuno & Neuro Lipids at a dose of 0.5 ml / kg body weight per day in two / three divided doses for 90 days.

Other names: BioMarine®Medical Immuno&Neuro Lipids

Primary outcomes

  1. Change in peripheral blood NK cell activity

    Time frame: baseline, 90 days

    NK cell activity using a mixed culture of PBMC with target cells (ability to inhibit tumor cell proliferation) assessed by flow cytometry.

  2. Change in the number and percentage of peripheral blood NK cells, CD8 cells, CD4 cells, CD19 cells

    Time frame: baseline, 90 days

    Absolute number and percentage of NK cells (CD16 + CD56 +), cytotoxic (CD8 +), helper (CD4 +) lymphocytes, B (CD19 +) in the total pool of peripheral blood mononuclear cells (PBMC) by flow cytometry.

  3. Change in the production of cytokines (INF-α, INF-β, INF-γ, IL-6 and TNF) by peripheral blood mononuclear cells

    Time frame: baseline, 90 days

    Ability of isolated PBMCs to synthesize INF-α, INF-β, INF-γ, IL-6 and TNF without and after polyclonal stimulation (PHA) and SARS-CoV-2 proteins (nucleocapside protein, SARS-CoV-2 spike protein ) in 42 h culture based on the determination of the level of protein released into the culture fluid and on the basis of mRNA expression for these factors. Analysis of PBMC post-culture supernatants (CBA technique with flow cytometer and gene expression analysis by qPCR).

Secondary outcomes

  1. Change in serum lipid content

    Time frame: baseline, 90 days

    Analysis of lipid composition using gas/spectrum chromotography

  2. Change in in lipid content in PBMC lyophilisates

    Time frame: baseline, 90 days

    Analysis of lipid composition using gas/spectrum chromotography

Sponsors and collaborators

Lead sponsor

Marinex International Sp. z o.o.

Industry

Registry information

Official study title

Evaluation of the Effectiveness of Nutritional Intervention With Fish-derived Lipids in Improving Antiviral Immunity in Healthy People

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2022
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.