Fiber Tolerance Study

NCT06115057 | Completed Early Phase 1

• 2 other identifiers: 23REX0058665NL84292.056.23
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.

Conditions

Gastrointestinal Tolerance of Dietary Fiber

Keywords

Fiber Tolerance Gastro-intestinal Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• GSRS change

  week 1, week 2, week 3,

• GSRS change

  week 1, week 2, week 3, week 4

Other Outcomes (5)

• GSRS

  week 1, week 2, week 3, week 4

• BSFC

  week 1, week 4

• Defecation frequency

  week 1, week 2, week 3, week 4

Study Arms (1)

Intervention

EXPERIMENTAL

Fiber

Dietary Supplement: Fiber

Interventions

Fiber DIETARY_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.

Intervention

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nutricia Research: lead
• NCRU (Nutrition Clinical Research Unit): collaborator

Study Sites (1)

Nutrition Clinical Research Unit

Utrecht, 3584CT, Netherlands

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, single-arm, single-site

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: November 2, 2023
• Study Start: October 4, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)