Gastrointestinal Tolerance of Dietary FiberEarly Phase 1GitomixNCT06115057
Fiber Tolerance Study
A Early Phase 1 study testing Fiber in people with Gastrointestinal Tolerance of Dietary Fiber, run by Nutricia Research at 1 site in Netherlands.
Trial summary
Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Read more about this study
- Who is it for?
- Ages 45 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance of Dietary Fiber
- What is being tested?
- Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Oct 2023to 22 Dec 2023
- Phase
- Early Phase 1
- 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 45 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 45 and ≤ 70 years
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed consent form
- Willingness and ability to comply with the protocol
- Good general health
- Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening.
Who cannot join
- Presence or history of chronic gastrointestinal disorders (e.g. stomach ulcers, ulcerative colitis, Crohn's disease) or history of abdominal surgery with resection of the bowel (small or large intestine).
- Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:
- autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus).
- eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder).
- intestinal/gastrointestinal disorder due to a stroke.
- Chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) that cannot be controlled with the use of medication/therapy.
Show all 11Show fewer
- Severe acute liver disease or chronic liver disease.
- Severe or chronic kidney disease or need for hemodialysis.
- Colonoscopy, irrigoscopy or other bowel cleansing, or other surgical procedures related to the gastrointestinal tract (eg. colon polypectomy, appendectomy) or for which use of systemic antibiotics within 1 month before the screening is required or scheduled during participation in the study.
- Use of enemas, laxatives, antacids, proton pump inhibitors, prokinetics (e.g. metoclopramide, drugs that affect motility), digestive enzymes, narcotic/morphine analgesics within 1 week prior to screening or intended use during participation in the study.
- Following a vegetarian or vegan diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women
Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.
- Being tested
- Fiber
- Keywords
- Fiber Tolerance Gastro-intestinal Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberDietary supplement
Subjects in this study are to consume the study product twice daily during regular meals.
The fiber mix consists of different types of dietary fiber that are individually well tolerated for human consumption.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Fiber Receives: Dietary Supplement: Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSRS change
Change from baseline in the reported severity of GI symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) for diarrhea dimension at week 4 post-baseline.
Measured: 4 weeks
Secondary outcomes (2)
GSRS change
Weekly changes from baseline in the reported severity of GI symptoms assessed by the GSRS for diarrhea dimension at week 1, week 2, and week 3 post-baseline.
Measured: week 1, week 2, week 3,
GSRS change
Weekly changes from baseline in the reported severity of GI symptoms assessed by the GSRS for abdominal pain, constipation, indigestion, and reflux dimensions at week 1, week 2, week 3, and week 4.
Measured: week 1, week 2, week 3, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start4 Oct 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 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 Gastrointestinal Tolerance of Dietary FiberStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, single-arm, single-site
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NCRU (Nutrition Clinical Research Unit)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115057
- Sponsor's protocol ID
- 23REX0058665
- Other IDs
- NL84292.056.23
- Acronym
- Gitomix
- Status last verified
- Feb 2024
- First submitted
- 18 Sep 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dopheide L, Kozior M, Buco A, van Bergenhenegouwen J, Tims S, de Vogel-van den Bosch J, Roberts J, Jonkers D, Harvey L, van Helvoort A. A Diverse Fiber Mixture, Reflective of a Nutritionally Balanced Diet, Is Well Tolerated by Healthy Adults. Curr Dev Nutr. 2026 Apr 18;10(6):107695. doi: 10.1016/j.cdnut.2026.107695. eCollection 2026 Jun.
PubMed 42231910
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women
- ClinicalTrials.gov ID
- NCT06115057
- Acronym / sponsor ID
- Gitomix / 23REX0058665
- Keywords
- Fiber Tolerance Gastro-intestinal Safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Collaborators
- NCRU (Nutrition Clinical Research Unit)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 2 Nov 2023 (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.
Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, single-arm, single-site
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: FiberFiber |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 45 and ≤ 70 years
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed consent form
- Willingness and ability to comply with the protocol
- Good general health
Key exclusion criteria (11 listed)
- Presence or history of chronic gastrointestinal disorders (e.g. stomach ulcers, ulcerative colitis, Crohn's disease) or history of abdominal surgery with resection of the bowel (small or large intestine).
- Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:
- Chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) that cannot be controlled with the use of medication/therapy.
- Severe acute liver disease or chronic liver disease.
- Severe or chronic kidney disease or need for hemodialysis.
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 |
|---|---|---|
| FiberSubjects in this study are to consume the study product twice daily during regular meals. The fiber mix consists of different types of dietary fiber that are individually well tolerated for human consumption. | Dietary supplement | Intervention |
Primary outcome
GSRS change
Time frame: 4 weeks
Change from baseline in the reported severity of GI symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) for diarrhea dimension at week 4 post-baseline.
2 secondary outcomes
GSRS change
Time frame: week 1, week 2, week 3,
GSRS change
Time frame: week 1, week 2, week 3, week 4
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 6 Feb 2024.
- Derived from this study: PubMed 42231910Dopheide L, Kozior M, Buco A, van Bergenhenegouwen J, Tims S, de Vogel-van den Bosch J, Roberts J, Jonkers D, Harvey L, van Helvoort A. A Diverse Fiber Mixture, Reflective of a Nutritionally Balanced Diet, Is Well Tolerated by Healthy Adults. Curr Dev Nutr. 2026 Apr 18;10(6):107695. doi: 10.1016/j.cdnut.2026.107695. eCollection 2026 Jun.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fiber in people with Gastrointestinal Tolerance of Dietary Fiber, run by Nutricia Research at 1 site in Netherlands.
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 6 inclusion and 11 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 6 Feb 2024. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
GSRS change (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 NCT06115057, 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 6 Feb 2024.