Effects of Dietary Fiber on Gastrointestinal Function | NCT01495182

Studies
Effects of Dietary Fiber on Gastrointestinal Function

NCT01495182

Sponsor

Ingredion Incorporated

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Gastrointestinal Health

Interventions

Dietary fiber

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 15, 2011

First Posted Date

Dec 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dietary Fiber - Dose 1	Experimental	Dietary fiber will be added to study foods	Other: Dietary fiber
Dietary Fiber - Dose 2	Experimental	Dietary fiber will be added to study foods	Other: Dietary fiber
Control	Active Comparator	Study foods with no added fiber will be given	Other: Dietary fiber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary fiber	Other	A proprietary fiber will be given to subjects	Control Dietary Fiber - Dose 1 Dietary Fiber - Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastrointestinal tolerability	Questionnaire to assess symptoms such as nausea, bloating, and flatulence	subjects will report weekly for 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fecal output	Fecal weight and stool characteristics will be measured	subjects will collect fecal output for 12 days within a six-week period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Maki, PhD	Provident Clinical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Provident Clinical Research and Consulting Inc		Glen Ellyn	Illinois	60137	United States

Intervention Browse Module

MeSH Terms

ID	Term
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided