Department of Periodontology and Oral Diseases
Lodz, 92-213, Poland
NCT Number: NCT05502172
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.
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Notify Me20 year–40 year
All sexes
Interventional
Not applicable
Lodz, 92-213, Poland
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:
Blood sampling will be repeated after 90 days in order to determine the influence of the fish oils on the tested parameters.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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).
Time frame: baseline, 90 days
Analysis of lipid composition using gas/spectrum chromotography
Time frame: baseline, 90 days
Analysis of lipid composition using gas/spectrum chromotography
Marinex International Sp. z o.o.
Industry
Evaluation of the Effectiveness of Nutritional Intervention With Fish-derived Lipids in Improving Antiviral Immunity in Healthy People
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