Healthy Male VolunteersNUTRIBIOTENCT05105425
The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers.
A study testing NUTRIOSE® in people with Healthy Male Volunteers, run by Roquette Freres at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- NUTRIOSE®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jul 2021to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteer,
- Age between 18 and 60 years (limits included),
- BMI between 18.5 and 25 kg/m² (limits included),
- Having a high or a low usual fiber consumption,
- With a usual normal intestinal transit. According to stool questionnaire completed between V1 and V2, mean of the 7 days of completion, maximum 3 stools / day and 5 stools/weeks minimum and with mean normal consistency (from type 3 to type 5 of the BSFS and with a tolerance of 1 to 3 stools in deviation /week) according to the investigator's opinion,
- Non-smoking or with tobacco consumption < 5 cigarettes / day and agreeing to keep his smoking habits unchanged during the all duration of the study,
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- Weight stable within ± 5% in the last three months;
- No significant change in food habits or in physical activity in the 3 months before the study and agreeing to keep these habits unchanged throughout the study;
- Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme
- Agreeing to be registered on the national file of volunteers in biomedical research file.
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 or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- Lactose intolerant,
- Having undergone recent surgical procedure in the past 6 months or planned in 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 V1 visit, i.e. medication with impact on intestinal transit such as anti-diarrheal, anti-spasmodic, antidepressants antibiotics, antacids, laxative, antifungal, NSAI, antivomiting, 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 prebiotic, probiotic, synbiotics, fiber, fermented milk or yogurt, kefir, ultra-yeast, vitamins and minerals or stopped less than 3 months before the inclusion visit (V1);
- With a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian…) or stopped less than 3 months before the study,
- With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
- Consuming more than 3 standard drinks of alcoholic beverage or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
- Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded),
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Impossible to contact in case of emergency.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinical Investigation Unit of Biofortis Paris
Paris, 75012
Clinical Investigation Unit of Biofortis
Saint-Herblain, 44800
About this study
Official title: The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo Conrolled Pilot Study.
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
- Being tested
- NUTRIOSE®, GLUCIDEX® IT21 (Placebo)
- 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 (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).
GLUCIDEX® IT21 (Placebo)Dietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| NUTRIOSE® | Active comparator | 1 sachet to be taken at breakfast during 4 weeks Receives: Dietary Supplement: NUTRIOSE® |
| GLUCIDEX® IT21 | Placebo comparator | 1 sachet to be taken at breakfast during 4 weeks Receives: Dietary Supplement: GLUCIDEX® IT21 (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison at V3 of relative abundance of Parabacteroides genus in intestinal microbiota
Assessed via Shotgun metagenomics analysis
Measured: 4 weeks
Secondary outcomes (6)
Comparison at V4 of relative abundance of Parabacteroides genus in intestinal microbiota.
Assessed via Shotgun metagenomics analysis
Measured: 7 or 8 weeks
Comparisons at V3 and V4 of relative abundance of intestinal microbiota (Bacterial species of Parabacteroides genus, Bacteroides genus, Firmicutes phylum, the functional levels of the intestinal microbiota, ...)
Assessed via Shotgun metagenomics analysis
Measured: 2 weeks
Comparisons at V3 and V4 of intestinal parameters : Fecal pH
Assessed via laboratory analyse (no unit)
Measured: 2 weeks
Comparisons at V3 and V4 of intestinal parameters: Fecal short chain fatty acids (SCFA)
Assessed via laboratory analyse (µmol/g)
Measured: 2 weeks
Comparisons at V3 and V4 of intestinal parameters: Secretory immunoglobulin A in feces
Assessed via laboratory analyse (mg/g)
Measured: 2 weeks
The frequency of adverse events
Treatment-Emergent Adverse Events (TEAE), Serious treatment-emergent adverse events (STEAE), TEAEs leading to Investigational Product (IP) discontinuation, Treatment-Emergent Adverse Reaction (TEAR) and gastro-intestinal TEAE.
Measured: 7 or 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start19 Jul 2021
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male 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
- 124 participants (actual)
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
- NCT05105425
- Sponsor's protocol ID
- 2020-A03403-36
- Acronym
- NUTRIBIOTE
- Status last verified
- Apr 2024
- First submitted
- 1 Jul 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perreau C, Tomassi D, Capronnier O, Carton T, Thabuis C, Guerin-Deremaux L. Resistant dextrin promotes beneficial fecal bacteria in high and low fiber diet populations: a randomized, double-blinded, controlled pilot study. Front Nutr. 2026 May 20;13:1810842. doi: 10.3389/fnut.2026.1810842. eCollection 2026.
PubMed 42245546
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. 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 Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo Conrolled Pilot Study.
- ClinicalTrials.gov ID
- NCT05105425
- Acronym / sponsor ID
- NUTRIBIOTE / 2020-A03403-36
- Conditions
- Healthy Male Volunteers
- Keywords
- Dietary fiber, Microbiota, Stool collection, Shotgun
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Roquette FreresIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 3 Nov 2021 (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 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.
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® | Active comparator | Dietary Supplement: NUTRIOSE®1 sachet to be taken at breakfast during 4 weeks |
| GLUCIDEX® IT21 | Placebo comparator | Dietary Supplement: GLUCIDEX® IT21 (Placebo)1 sachet to be taken at breakfast during 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male volunteer,
- Age between 18 and 60 years (limits included),
- BMI between 18.5 and 25 kg/m² (limits included),
- Having a high or a low usual fiber consumption,
- With a usual normal intestinal transit. According to stool questionnaire completed between V1 and V2, mean of the 7 days of completion, maximum 3 stools / day and 5 stools/weeks minimum and with mean normal consistency (from type 3 to type 5 of the BSFS and with a tolerance of 1 to 3 stools in deviation /week) according to the investigator's opinion,
Key exclusion criteria (17 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 or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- Lactose intolerant,
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 (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 | NUTRIOSE® |
| 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). | Dietary supplement | GLUCIDEX® IT21 |
Primary outcome
Comparison at V3 of relative abundance of Parabacteroides genus in intestinal microbiota
Time frame: 4 weeks
Assessed via Shotgun metagenomics analysis
6 secondary outcomes
Comparison at V4 of relative abundance of Parabacteroides genus in intestinal microbiota.
Time frame: 7 or 8 weeks
Comparisons at V3 and V4 of relative abundance of intestinal microbiota (Bacterial species of Parabacteroides genus, Bacteroides genus, Firmicutes phylum, the functional levels of the intestinal microbiota, ...)
Time frame: 2 weeks
Comparisons at V3 and V4 of intestinal parameters : Fecal pH
Time frame: 2 weeks
Comparisons at V3 and V4 of intestinal parameters: Fecal short chain fatty acids (SCFA)
Time frame: 2 weeks
Comparisons at V3 and V4 of intestinal parameters: Secretory immunoglobulin A in feces
Time frame: 2 weeks
The frequency of adverse events
Time frame: 7 or 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 42245546Perreau C, Tomassi D, Capronnier O, Carton T, Thabuis C, Guerin-Deremaux L. Resistant dextrin promotes beneficial fecal bacteria in high and low fiber diet populations: a randomized, double-blinded, controlled pilot study. Front Nutr. 2026 May 20;13:1810842. doi: 10.3389/fnut.2026.1810842. eCollection 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUTRIOSE® in people with Healthy Male Volunteers, run by Roquette Freres at 2 sites in France.
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 12 inclusion and 17 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: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison at V3 of relative abundance of Parabacteroides genus in intestinal microbiota (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105425, which also lists 1 linked publication.
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 25 Apr 2024.