Immune ResponseNUTIVACNCT05313451
Evaluation of the Effect of a Soluble Fiber Consumption on Immunity Response
A study testing Soluble fiber in people with Immune Response, run by CEN Biotech at 1 site in France.
Trial summary
At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day significantly increased the titer of antibodies… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Soluble fiber
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to 18 Aug 2022
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- Subject with a body mass index (BMI) of 18.0-30.0 kg/m 2
- Subject with regular upper respiratory tract infections(nasopharyngitis, flu-like illness, flu, cold...)
- Subject accepting the anti-influenza virus vaccination
- Subject agreeing to maintain lifestyle and dietary habits over the study
Main Exclusion Criteria:
- Subject having had the flu during the current season
- Subject having presented a viral or bacterial infection in the past 7 days prior to inclusion
- Subject with a known allergy to one of the compounds of products administered in the study or in accordance with indications of the vaccine
- Subject having presented manifestations of allergy during previous flu vaccinations
- Subject with ongoing gastrointestinal disease or chronic gastrointestinal disease (IBS, Crohn's disease, etc.)
- Suffering from diabetes, an autoimmune disease, a disease inflammation or a major or progressive pathology
- Pregnant women (negative urine pregnancy test for women of childbearing age), breastfeeding or planning a pregnancy in the coming months
- Subject who has already received the influenza vaccine for the current season
- Subject having received any vaccination during the last month prior to inclusion
- Subject who received antibiotic therapy within the last two month
- Taking any dietary supplements or enriched foods that are presented as having an action on immunity and/or on the intestinal sphere (prebiotics, probiotics, vitamins, plant extracts...) in the last month.
- Taking immunomodulatory or immunosuppressive drugs
- Taking any treatment that the investigator believes may interfere with investigation endpoints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Soluble Fiber Consumption on the Immune Response Post-influenza Vaccination in Healthy Subjects Aged 50 to 70 Years
At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day significantly increased the titer of antibodies directed against the H3N2 viral strain. The increase in bifidobacteria in the faeces confirmed that this effect was related to prebiotic capacities. The effect of prebiotics and probiotics on the immune response to influenza virus vaccination has been studied in two systematic reviews and meta-analyses. The authors show that the consumption of prebiotic fibers such as FOS, GOS, inulin, was also effective on the H3N2 strain, as on the H1N1 and B strains (antibody titers of 19.5%, 20.0% and 13.6% higher, respectively, compared to placebo).
The soluble fiber under study is a resistant dextrin meeting the definition of a prebiotic fibre. The prebiotic properties have been demonstrated in humans in several studies for doses ranging from 10 to 20 g/day. Similarly, studies show that the effects on immune functions are favorably impacted by a consumption of 10 g/day for 8 weeks . These results confirm those of a preclinical study conducted in mini-pigs.
The main objective of these study is to demonstrate that these prebiotic properties could help stimulate the post-vaccination immune response, and more specifically the production of antibodies directed against seasonal influenza viruses (following vaccination), and modulate the pro- and anti-inflammatory responses.
Read the detailed description
Screened participants who met the eligibility criteria are randomized either in the control or test (soluble fiber) group.
They are asked to ingest placebo or test product at 15 g/d dosing for 60 days (2 months) . At the end of the first month (30 days) they get vaccinated against influenza virus. The effect of soluble fiber on immune response is assessed by the comparison of HI titration 30 days after vaccination between groups.
- Conditions
- Immune Response
- Being tested
- Soluble fiber, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble fiberOther
15g/day during 2 months
PlaceboOther
Maltodextrin 15g/day during 2 months
| Study group | Role | What they receive |
|---|---|---|
| Soluble fiber | Experimental | Participants ingest 15 g daily of the experimental product for 2 months and receive the influenza vaccine at the end of the first month. Receives: Other: Soluble fiber |
| Placebo | Placebo comparator | Participants ingest 15 g daily of the placebo product for 2 months and receive the influenza vaccine at the end of the first month. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HI titers at 2 months
hemagglutination inhibition (HI) antibody titers after vaccination
Measured: at Month 1 (before influenza vaccination), at Month 2 (one month after influenza vaccination)
Secondary outcomes (5)
Intestinal Microbiota
The microbiota is characterized using the Shotgun bacterial DNA analysis method on feces samples
Measured: at month 0, At month 1, at month 2
Inflammatory biomarker
Interleukins
Measured: at month 0, at month 1, at month 2
Cytokin biomarker
Tumour Necrosis Factor alpha cytokin
Measured: at month 0, at month 1, at month 2
Incidence of Treatment on hematologic blood parameters
Complete blood count
Measured: at month 0, at month 1, at month 2
Incidence of Treatment on biochemical blood parameters
Transaminases
Measured: at month 0, at month 1, at month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start7 Feb 2022
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roquette Freres
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313451
- Sponsor's protocol ID
- 1699
- Acronym
- NUTIVAC
- Status last verified
- Aug 2023
- First submitted
- 2 Mar 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Soluble Fiber Consumption on the Immune Response Post-influenza Vaccination in Healthy Subjects Aged 50 to 70 Years
- ClinicalTrials.gov ID
- NCT05313451
- Acronym / sponsor ID
- NUTIVAC / 1699
- Conditions
- Immune Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Roquette Freres
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 6 Apr 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.
At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day significantly increased the titer of antibodies directed against the H3N2 viral strain. The increase in bifidobacteria in the faeces confirmed that this effect was related to prebiotic capacities. The effect of prebiotics and probiotics on the immune response to influenza virus vaccination has been studied in two systematic reviews and meta-analyses. The authors show that the consumption of prebiotic fibers such as FOS, GOS, inulin, was also effective on the H3N2 strain, as on the H1N1 and B strains (antibody titers of 19.5%, 20.0% and 13.6% higher, respectively, compared to placebo).
The soluble fiber under study is a resistant dextrin meeting the definition of a prebiotic fibre. The prebiotic properties have been demonstrated in humans in several studies for doses ranging from 10 to 20 g/day. Similarly, studies show that the effects on immune functions are favorably impacted by a consumption of 10 g/day for 8 weeks . These results confirm those of a preclinical study conducted in mini-pigs.
The main objective of these study is to demonstrate that these prebiotic properties could help stimulate the post-vaccination immune response, and more specifically the production of antibodies directed against seasonal influenza viruses (following vaccination), and modulate the pro- and anti-inflammatory responses.
Detailed description
Screened participants who met the eligibility criteria are randomized either in the control or test (soluble fiber) group.
They are asked to ingest placebo or test product at 15 g/d dosing for 60 days (2 months) . At the end of the first month (30 days) they get vaccinated against influenza virus. The effect of soluble fiber on immune response is assessed by the comparison of HI titration 30 days after vaccination between groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soluble fiber | Experimental | Other: Soluble fiberParticipants ingest 15 g daily of the experimental product for 2 months and receive the influenza vaccine at the end of the first month. |
| Placebo | Placebo comparator | Other: PlaceboParticipants ingest 15 g daily of the placebo product for 2 months and receive the influenza vaccine at the end of the first month. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Soluble fiber15g/day during 2 months | Other | Soluble fiber |
| PlaceboMaltodextrin 15g/day during 2 months | Other | Placebo |
Primary outcome
Change from baseline HI titers at 2 months
Time frame: at Month 1 (before influenza vaccination), at Month 2 (one month after influenza vaccination)
hemagglutination inhibition (HI) antibody titers after vaccination
5 secondary outcomes
Intestinal Microbiota
Time frame: at month 0, At month 1, at month 2
Inflammatory biomarker
Time frame: at month 0, at month 1, at month 2
Cytokin biomarker
Time frame: at month 0, at month 1, at month 2
Incidence of Treatment on hematologic blood parameters
Time frame: at month 0, at month 1, at month 2
Incidence of Treatment on biochemical blood parameters
Time frame: at month 0, at month 1, at month 2
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 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble fiber in people with Immune Response, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Dec 2023. 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 France. 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. Some participants in this study may receive a placebo. 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 from baseline HI titers at 2 months (time frame: at Month 1 (before influenza vaccination), at Month 2 (one month after influenza vaccination)). 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 26 Dec 2023.