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The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers.

NCT05105425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-04-25

No results posted yet for this study

Summary

The effects of daily supplementation of the NUTRIOSE® on the fecal microbiota. The hypothesis of the study is that the NUTRIOSE® is able to modulate the intestinal microbiota in a positive way, compare to a placebo, in healthy volunteers.

Conditions

  • Healthy Male Volunteers

Interventions

DIETARY_SUPPLEMENT

NUTRIOSE®

After randomization (V2 visit), the subjects will consume per os, from V2 to V3, 1 sachet of 15g per day, in the morning, of active formula (NUTRIOSE®) during 4 weeks. They will consume 1 sachet in the morning. Powder will have to be mixed with usual beverage of the subject (whatever the type of drink, cold or hot).

DIETARY_SUPPLEMENT

GLUCIDEX® IT21 (Placebo)

After randomization (V2 visit), the subjects will consume per os, from V2 to V3, 1 sachet of 15g per day, in the morning, of placebo during 4 weeks. They will consume 1 sachet in the morning. Powder will have to be mixed with usual beverage of the subject (whatever the type of drink, cold or hot).

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Roquette Freres

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2023-08-07
Completion
2023-08-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105425 on ClinicalTrials.gov