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OpenTrials
Completed

NCT Number: NCT06115057

Fiber Tolerance Study

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.

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Key information

Age range

45 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Nutrition Clinical Research Unit

Utrecht, 3584CT, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. GSRS change

    Time frame: week 1, week 2, week 3,

    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.

  2. GSRS change

    Time frame: week 1, week 2, week 3, week 4

    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.

Other outcomes

  1. GSRS

    Time frame: week 1, week 2, week 3, week 4

    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].

  2. BSFC

    Time frame: week 1, week 4

    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.

  3. Defecation frequency

    Time frame: week 1, week 2, week 3, week 4

    Weekly average frequency of defecation, derived from the number of faecal form types assessed by the Bristol Stool Form Chart.

  4. DQLQ

    Time frame: 4 weeks

    Digestion-associated Quality of life assessed by the Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline and at week 4 post-baseline.

  5. Stool

    Time frame: week 2, week 3, week 4

    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

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Collaborators

  • NCRU (Nutrition Clinical Research Unit)

Registry information

Official study title

The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women

Acronym: Gitomix

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.