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

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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: fish oil

Detailed Description

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:

1. NK cell activity using a mixed culture of PBMC with target cells (ability to inhibit tumor cell proliferation) assessed by flow cytometry.
2. 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.
3. 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).
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 92-213
    • Department of Periodontology and Oral Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fish oil; Healthy individuals will be taking the 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.	Dietary supplement: fish oil; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peripheral blood NK cell activity	NK cell activity using a mixed culture of PBMC with target cells (ability to inhibit tumor cell proliferation) assessed by flow cytometry.	baseline, 90 days
Change in the number and percentage of peripheral blood NK cells, CD8 cells, CD4 cells, CD19 cells	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.	baseline, 90 days
Change in the production of cytokines (INF-α, INF-β, INF-γ, IL-6 and TNF) by peripheral blood mononuclear cells	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).	baseline, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum lipid content	Analysis of lipid composition using gas/spectrum chromotography	baseline, 90 days
Change in in lipid content in PBMC lyophilisates	Analysis of lipid composition using gas/spectrum chromotography	baseline, 90 days

Collaborators and Investigators

• Sponsor: Marinex International Sp. z o.o.
• Investigators: Principal Investigator: Natalia Lewkowicz, prof., Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 10, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: fish oil; antiviral immune reponse
• Other Study ID Numbers: RNN/52/22/KE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No