The Effects of Daily Supplementation of a Soluble Fiber on the Fecal Microbiota in Volunteers.

NCT07846254 | Recruiting

• 1 other identifier: PEC24113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

dietary fiber; microbiota; stool collection; shotgun

Outcome Measures

Primary Outcomes (1)

• Relative abundance of Parabacteroides genus

  Relative abundance of Parabacteroides genus (assessed via shotgun metagenomics)

  After 4-week consumption

Secondary Outcomes (5)

• Comparisons at V2 of relative abundance of intestinal microbiota: Relative abundance of Bacteroides genus, Species (formerly defined as Clostridium Cluster IV and XIV), Bacillota phylum, Overall composition at the taxonomic level

  After 4-week consumption

• Comparisons at V2 of bowel movements: stool frequency

  After 4-week consumption

• Comparisons at V2 of bowel movements: stool consistency

  After 4-week consumption

• Comparisons at V2 of digestive well-being and bowel transit

  after 4-week consumption

• Occurrence of adverse events (AEs) and especially gastrointestinal AEs

  after 4-weeks consumption

Study Arms (2)

NUTRIOSE® soluble fiber

ACTIVE COMPARATOR

1 sachet to be taken at breakfast during 4 weeks

Dietary Supplement: NUTRIOSE®

GLUCIDEX® IT19 maltodextrin

PLACEBO COMPARATOR

1 sachet to be taken at breakfast during 4 weeks

Dietary Supplement: Active comparator

Interventions

NUTRIOSE® DIETARY_SUPPLEMENT

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).

NUTRIOSE® soluble fiber

Active comparator DIETARY_SUPPLEMENT

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).

GLUCIDEX® IT19 maltodextrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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);
• 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);
• 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.

Sponsors & Collaborators

• Roquette Freres: lead
• BioFortis: collaborator

Study Sites (1)

Mérieux NutriSciences

Addison, Illinois, 60101, United States

RECRUITING

MeSH Terms

Interventions

NUTRIOSE

Central Study Contacts

Elizabeth Antoo, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: September 29, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

US (1)