Healthy VolunteersNUTRIPOWERNCT07846254
The Effects of Daily Supplementation of a Soluble Fiber on the Fecal Microbiota in Volunteers.
A study testing NUTRIOSE® and Active comparator in people with Healthy Volunteers, run by Roquette Freres at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NUTRIOSE® and Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mérieux NutriSciences
Addison, Illinois, 60101
Elizabeth Antoo, Dr, 630-617-2000, elizabeth.antoo@mxns.com
About this study
Official title: The Effects of Daily Supplementation of NUTRIOSE® on the Fecal Microbiota in Healthy Adult Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo-controlled Study
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
- Being tested
- NUTRIOSE®, Active comparator
- Keywords
- dietary fiber, microbiota, stool collection, shotgun
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Active comparatorDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| NUTRIOSE® soluble fiber | Active comparator | 1 sachet to be taken at breakfast during 4 weeks Receives: Dietary Supplement: NUTRIOSE® |
| GLUCIDEX® IT19 maltodextrin | Placebo comparator | 1 sachet to be taken at breakfast during 4 weeks Receives: Dietary Supplement: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of Parabacteroides genus
Relative abundance of Parabacteroides genus (assessed via shotgun metagenomics)
Measured: 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
Assessed via Shotgun metagenomics analysis
Measured: After 4-week consumption
Comparisons at V2 of bowel movements: stool frequency
Mean number of stools per day (assessed on a 7-day diary before each visit, from V2-1 to V2-7 days)
Measured: After 4-week consumption
Comparisons at V2 of bowel movements: stool consistency
Proportion of each stool consistency type group 1-2, 3-5 and 6-7 (assessed on the 7-point Bristol stool scale [BSS], from V2-1 to V2-7 days)
Measured: After 4-week consumption
Comparisons at V2 of digestive well-being and bowel transit
7-point Likert scale (0 to 7): Patient global impression of change (PGI-C), for intestinal well-being and bowel transit.
Measured: after 4-week consumption
Occurrence of adverse events (AEs) and especially gastrointestinal AEs
Measured: after 4-weeks consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start31 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roquette Freres
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846254
- Sponsor's protocol ID
- PEC24113
- Acronym
- NUTRIPOWER
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Daily Supplementation of NUTRIOSE® on the Fecal Microbiota in Healthy Adult Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07846254
- Acronym / sponsor ID
- NUTRIPOWER / PEC24113
- Conditions
- Healthy Volunteers
- Keywords
- dietary fiber, microbiota, stool collection, shotgun
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roquette FreresIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NUTRIOSE® soluble fiber | Active comparator | Dietary Supplement: NUTRIOSE®1 sachet to be taken at breakfast during 4 weeks |
| GLUCIDEX® IT19 maltodextrin | Placebo comparator | Dietary Supplement: Active comparator1 sachet to be taken at breakfast during 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | NUTRIOSE® soluble fiber |
| Active comparatorAfter 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). | Dietary supplement | GLUCIDEX® IT19 maltodextrin |
Primary outcome
Relative abundance of Parabacteroides genus
Time frame: After 4-week consumption
Relative abundance of Parabacteroides genus (assessed via shotgun metagenomics)
5 secondary outcomes
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
Time frame: After 4-week consumption
Comparisons at V2 of bowel movements: stool frequency
Time frame: After 4-week consumption
Comparisons at V2 of bowel movements: stool consistency
Time frame: After 4-week consumption
Comparisons at V2 of digestive well-being and bowel transit
Time frame: after 4-week consumption
Occurrence of adverse events (AEs) and especially gastrointestinal AEs
Time frame: after 4-weeks consumption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRIOSE® and Active comparator in people with Healthy Volunteers, run by Roquette Freres at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Antoo, MD (630-617-2000, elizabeth.antoo@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of Parabacteroides genus (time frame: After 4-week consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.