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

NCT ID: NCT05502172

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2024-07-12

Brief Summary

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.

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.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fish oil

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BioMarine®Medical Immuno&Neuro Lipids

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marinex International Sp. z o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Natalia Lewkowicz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalia Lewkowicz, prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz

Locations

Department of Periodontology and Oral Diseases

Lodz, , Poland

Countries

Poland

Other Identifiers

RNN/52/22/KE

Identifier Type: -

Identifier Source: org_study_id