Fiber Tolerance Study

NCT ID: NCT06115057

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2023-12-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Fiber

Group Type: EXPERIMENTAL

Fiber

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NCRU (Nutrition Clinical Research Unit)

UNKNOWN

Sponsor Role: collaborator

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nutrition Clinical Research Unit

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

NL84292.056.23

Identifier Type: OTHER

Identifier Source: secondary_id

23REX0058665

Identifier Type: -

Identifier Source: org_study_id