Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05313451
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2022-03-02
Brief Title:
Evaluation of the Effect of a Soluble Fiber Consumption on Immunity Response
Sponsor:
CEN Biotech
Organization:
CEN Biotech
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUTIVAC
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 8gday 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 195 200 and 136 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 gday Similarly studies show that the effects on immune functions are favorably impacted by a consumption of 10 gday 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
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 gday Similarly studies show that the effects on immune functions are favorably impacted by a consumption of 10 gday 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 gd 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
They are asked to ingest placebo or test product at 15 gd 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None