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

August 10, 2024 updated by: Natalia Lewkowicz, Marinex International Sp. z o.o.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 90 days
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.
baseline, 90 days
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).
baseline, 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in serum lipid content
Time Frame: baseline, 90 days
Analysis of lipid composition using gas/spectrum chromotography
baseline, 90 days
Change in in lipid content in PBMC lyophilisates
Time Frame: baseline, 90 days
Analysis of lipid composition using gas/spectrum chromotography
baseline, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marinex International Sp. z o.o.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalia Lewkowicz, prof., Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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