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

NCT05502172 | Completed

• 1 other identifier: RNN/52/22/KE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition, Healthy

Keywords

fish oil; antiviral immune reponse

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in serum lipid content

  baseline, 90 days

• Change in in lipid content in PBMC lyophilisates

  baseline, 90 days

Study Arms (1)

fish oil

EXPERIMENTAL

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

Interventions

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.

Also known as: BioMarine®Medical Immuno&Neuro Lipids

fish oil

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marinex International Sp. z o.o.: lead

Study Sites (1)

Department of Periodontology and Oral Diseases

Lodz, 92-213, Poland

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Natalia Lewkowicz, prof.

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 16, 2022
• Study Start: November 18, 2022
• Primary Completion: February 1, 2024
• Study Completion: July 12, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)