Recruiting

NUTRIOSE®

Sponsor:

Roquette Freres

Code:

NCT07846254

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

NUTRIOSE®

Active comparator

Study Details

Brief summary:

The effects of daily supplementation with NUTRIOSE® on the fecal microbiota. The study aims to evaluate the ability of NUTRIOSE® to support a beneficial modulation of the intestinal microbiota in healthy volunteers, compared with a placebo.

Conditions

Healthy Volunteers

Study ID

NCT07846254

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and women aged ≥ 18 and ≤ 60 years;
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m²;
  • With a usual normal intestinal transit (according to BSS). According to stool questionnaire completed between V0 and V1, mean of the 7 days of completion, maximum 3 stools / day and 3 stools/week minimum and with mean normal consistency
  • Good general and mental health according to the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
  • Agreement to maintain lifestyle habits during the study (same dietary and physical habits);
  • Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form (ICF);
  • Affiliated with a social security scheme;

Exclusion Criteria:

  • Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder;
  • Suffering from gastrointestinal disorders such as celiac disease, Crohn's disease, functional constipation, irritable bowel syndrome or another gastrointestinal found to be inconsistent with the study according to the investigator;
  • Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, uncontrolled cardiac disease, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or another severe disorders found to be inconsistent with the conduct of the study by the investigator;
  • With a known food allergy or intolerance or hypersensitivity to any ingredient of the IP;
  • Pregnant or lactating women or intending to become pregnant within 6 months ahead;
  • Having undergone recent surgical procedure in the past 6 months or planned on the 2 months to come;
  • Under treatment which could significantly affect parameter(s) followed during the study according to the investigator or stopped less than 4 weeks before the V0 visit, i.e. medication with impact on intestinal transit such as anti-diarrheal, anti-spasmodic,antidepressants antibiotics, antacids, laxative, antifungal, NSAI, anti-vomiting, GLP-1 receptor agonists, corticoids, opioids, narcotic analgesic and biliary acids chelator, and chronic hormonal treatment started less than 3 months ago (i.e. new method of hormonal contraception, thyroidal trouble treatment);
  • Regular intake of dietary supplements or "health foods", or products known to impact intestinal microbiota, containing or rich in prebiotics, probiotics, symbiotic, fibre, fermented milk or yogurt, kefir, ultra-yeast, vitamins and minerals, or stopped less than 3 months before the inclusion visit.
  • With significant change in dietary or physical activity habits in the 3 months before randomization (no hyper or hypocaloric diet, no high-protein diet, no prolonged fasting for more than one week, no planned change in the level of sports activity in the next 3 months);
  • Taking part in another clinical study or being in the exclusion period of a previous clinical study;
  • Under legal protection (guardianship, wardship) or deprived of his rights following the administrative or judicial decision;
  • Presenting psychological or linguistic incapability to sign the ICF;
  • Impossible to contact in case of emergency.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: NUTRIOSE® soluble fiber

1 sachet to be taken at breakfast during 4 weeks

placebo comparator: GLUCIDEX® IT19 maltodextrin

1 sachet to be taken at breakfast during 4 weeks

Interventions

NUTRIOSE®

After randomization (V1 visit), the subjects will consume per os, from V1 to V2, 1 sachet per day, in the morning, of 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).

Active comparator

After randomization (V1 visit), the subjects will consume per os, from V1 to V2, 1 sachet per day, in the morning, of GLUCIDEX® IT19 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).

Primary outcome measure

  • Relative abundance of Parabacteroides genus [ Time Frame: After 4-week consumption ]

Central Contacts and Locations

Central contacts

Elizabeth Antoo, MD

630-617-2000elizabeth.antoo@mxns.com

Locations

Mérieux NutriSciences

Recruiting

Addison, Illinois, United States, 60101

Contacts

Elizabeth Antoo, Dr

630-617-2000elizabeth.antoo@mxns.com

More Information

Sponsor

Roquette Freres

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • dietary fiber
  • microbiota
  • stool collection
  • shotgun

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Roquette Freres on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.