Evaluation of the Effect of a Soluble Fiber Consumption on Immunity Response

NCT05313451 | Completed

• 1 other identifier: 1699
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Immune Response

Outcome Measures

Primary Outcomes (1)

• Change from baseline HI titers at 2 months

  hemagglutination inhibition (HI) antibody titers after vaccination

  at Month 1 (before influenza vaccination), at Month 2 (one month after influenza vaccination)

Secondary Outcomes (5)

• Intestinal Microbiota

  at month 0, At month 1, at month 2

• Inflammatory biomarker

  at month 0, at month 1, at month 2

• Cytokin biomarker

  at month 0, at month 1, at month 2

• Incidence of Treatment on hematologic blood parameters

  at month 0, at month 1, at month 2

• Incidence of Treatment on biochemical blood parameters

  at month 0, at month 1, at month 2

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Soluble fiber OTHER

15g/day during 2 months

Soluble fiber

Placebo OTHER

Maltodextrin 15g/day during 2 months

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject having had the flu during the current season
• 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 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.

Sponsors & Collaborators

• CEN Biotech: lead
• Roquette Freres: collaborator

Study Sites (1)

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 6, 2022
• Study Start: February 7, 2022
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-08

Locations

FR (1)