NCT05105425

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

The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo Conrolled Pilot Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Roquette Freres · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2021-07-19
• Primary completion: 2023-08-07
• Completion: 2023-08-07
• First posted: 2021-11-03
• Last updated: 2024-04-25

Locations

2 sites across 1 country: France