Fiber Tolerance Study (Gitomix)

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance of Dietary Fiber
• Intervention / Treatment: Dietary supplement: Fiber

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584CT
    • Nutrition Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age ≥ 45 and ≤ 70 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
3. Signed consent form
4. Willingness and ability to comply with the protocol
5. Good general health
6. Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening.

Exclusion Criteria:

1. 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).

2. Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:

   1. autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus).
   2. eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder).
   3. intestinal/gastrointestinal disorder due to a stroke.
3. 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.
4. Severe acute liver disease or chronic liver disease.
5. Severe or chronic kidney disease or need for hemodialysis.
6. 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.
7. 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.
8. Following a vegetarian or vegan diet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Fiber	Dietary supplement: Fiber; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	week 1, week 2, week 3, week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GSRS	The reported severity of GI symptoms assessed by the GSRS between week 1 v week 2, week 1 v week 3, week 1 v week 4, week 2 v week 3, week 2 v week 4, and week 3 v week 4 [score].	week 1, week 2, week 3, week 4
BSFC	Weekly average faecal form type assessed by the Bristol Stool Form Chart at each defecation in the baseline week, at week 1, and week 4 post-baseline.	week 1, week 4
Defecation frequency	Weekly average frequency of defecation, derived from the number of faecal form types assessed by the Bristol Stool Form Chart.	week 1, week 2, week 3, week 4
DQLQ	Digestion-associated Quality of life assessed by the Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline and at week 4 post-baseline.	4 weeks
Stool	Microbiota and other outcome parameters assessed using collected faecal samples in the baseline week and every 7 days over 4 weeks post-baseline: Composition, diversity, and abundance of microbiota using 16S rRNA gene sequencing and processing; Short-chain fatty acids (SCFA); Branch-chain fatty acids (BCFA); Lactate; Ammonia; Calprotectin; Secretory immunoglobulin A (sIgA); pH	week 2, week 3, week 4

Collaborators and Investigators

• Sponsor: Nutricia Research
• Collaborators: NCRU (Nutrition Clinical Research Unit)

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Fiber Tolerance Gastro-intestinal Safety
• Other Study ID Numbers: 23REX0058665; NL84292.056.23 (Other Identifier: CCMO, The Netherlands)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No