Nutrition, HealthyNCT05502172
Effects of Nutritional Intervention With Fish-derived Lipids in Improving Antiviral Immunity
A study testing fish oil in people with Nutrition, Healthy, run by Marinex International Sp. z o.o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePoland
- Study dates
- 18 Nov 2022to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- absence of systemic diseases;
- no medications taken on a regular basis;
- correct body weight in relation to height - 18.5 ≤ BMI ≤ 24.9
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Nutrition, Healthy
- Being tested
- fish oil
- Keywords
- fish oil, antiviral immune reponse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
Also called BioMarine®Medical Immuno&Neuro Lipids
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: baseline, 90 days
Secondary outcomes (2)
Change in serum lipid content
Analysis of lipid composition using gas/spectrum chromotography
Measured: baseline, 90 days
Change in in lipid content in PBMC lyophilisates
Analysis of lipid composition using gas/spectrum chromotography
Measured: baseline, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start18 Nov 2022
- Primary completion1 Feb 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinex International Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Natalia Lewkowicz, Medical University of Lodz
- Investigators
- Natalia Lewkowicz, prof., Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502172
- Sponsor's protocol ID
- RNN/52/22/KE
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Nutritional Intervention With Fish-derived Lipids in Improving Antiviral Immunity in Healthy People
- ClinicalTrials.gov ID
- NCT05502172
- Acronym / sponsor ID
- RNN/52/22/KE
- Conditions
- Nutrition, Healthy
- Keywords
- fish oil, antiviral immune reponse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Marinex International Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fish oil | Experimental | Dietary Supplement: fish oilHealthy 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- absence of systemic diseases;
- no medications taken on a regular basis;
- correct body weight in relation to height - 18.5 ≤ BMI ≤ 24.9
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish oilAlso: BioMarine®Medical Immuno&Neuro Lipidshealthy 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. | Dietary supplement | fish oil |
Primary outcome
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.
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.
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).
2 secondary outcomes
Change in serum lipid content
Time frame: baseline, 90 days
Change in in lipid content in PBMC lyophilisates
Time frame: baseline, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Lewkowicz, prof. principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil in people with Nutrition, Healthy, run by Marinex International Sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peripheral blood NK cell activity (time frame: baseline, 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.