Effects of Dietary Fiber on Gastrointestinal Function

• Sponsor: Ingredion Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01495182
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Health	Other: Dietary fiber	N/A

Detailed Description

The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary Fiber - Dose 1 Dietary fiber will be added to study foods	Other: Dietary fiber; A proprietary fiber will be given to subjects
Experimental: Dietary Fiber - Dose 2 Dietary fiber will be added to study foods	Other: Dietary fiber; A proprietary fiber will be given to subjects
Active Comparator: Control Study foods with no added fiber will be given	Other: Dietary fiber; A proprietary fiber will be given to subjects

Outcome Measures

Primary Outcome Measures

1. Gastrointestinal tolerability [subjects will report weekly for 6 weeks]

   Questionnaire to assess symptoms such as nausea, bloating, and flatulence

Secondary Outcome Measures

1. Fecal output [subjects will collect fecal output for 12 days within a six-week period]

   Fecal weight and stool characteristics will be measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 54 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy men and women

• age 18 - 54 years

• BMI < 30 kg/m2

Exclusion Criteria:

• presence of GI or other serious diseases known to affect GI function

• recent use of antibiotics

• very high fiber intake

• use of medications known to affect GI function

• presence of allergies to study foods

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Provident Clinical Research and Consulting Inc	Glen Ellyn	Illinois	United States	60137

Sponsors and Collaborators

• Ingredion Incorporated

Investigators

• Principal Investigator: Kevin Maki, PhD, Provident Clinical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ingredion Incorporated
• ClinicalTrials.gov Identifier: NCT01495182
• Other Study ID Numbers: 002
• First Posted: Dec 19, 2011
• Last Update Posted: Apr 21, 2016
• Last Verified: Dec 1, 2011

• Keywords provided by Ingredion Incorporated: Dietary fiber; Gastrointestinal toleration; Fecal weight

Study Results

No Results Posted as of Apr 21, 2016