Status:
COMPLETED
Evaluation of the Effect of a Soluble Fiber Consumption on Immunity Response
Lead Sponsor:
CEN Biotech
Collaborating Sponsors:
Roquette Freres
Conditions:
Immune Response
Eligibility:
All Genders
50-70 years
Phase:
NA
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 w...
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 day...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05313451
Start Date
February 7 2022
End Date
August 18 2022
Last Update
December 26 2023
Active Locations (1)
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1
CEN Nutriment
Dijon, Bourgogne-Franche-Comté, France, 21000