Gastrointestinal Toleration of Inulin Products | NCT00958529

Studies
Gastrointestinal Toleration of Inulin Products

NCT00958529

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Feb 10, 2017Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Inulin Fiber Supplement

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

Feb 2017

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

Aug 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Aug 12, 2009

First Submission Date that Met QC Criteria

Aug 12, 2009

First Posted Date

Aug 13, 2009Estimated

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

Feb 9, 2017

Last Update Posted Date

Feb 10, 2017Actual

Name	Class
Cargill	INDUSTRY

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 intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products.

The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.

Detailed Description

0, 5, and 10 grams of inulin

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
inulin	Experimental	0, 5, 10 g inulin	Dietary Supplement: Inulin Fiber Supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inulin Fiber Supplement	Dietary Supplement	Orange juice fortified with 0, 5g, and 10g of 2 inulin products	inulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastrointestinal Tolerance Score		Aug 2008 thru Oct 2008

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

english speaking
healthy men and women
18 and 60 years of age
non-smoking
non-dieting
BMI less than 30
standard diet consisting of no more than 15 grams fiber
not taking medications

Exclusion Criteria:

BMI more than 30
CVD
Diabetes Mellitus
cancer in prior 5 years
renal or hepatic disease
bacterial infection in past 2 weeks
more than 5 kg weight loss in past 3 months
history of drug or alcohol abuse in past 6 months
use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications
concurrent or recent intervention study participation
consumption of laxatives
history of gastrointestinal disorders
food allergies
pregnant or lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanne L Slavin, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota: Nutrition and Food Science Department		Minneapolis	Minnesota	55108	United States