Gastrointestinal Toleration of Inulin Products

NCT ID: NCT00958529

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

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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

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0, 5, and 10 grams of inulin

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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inulin

0, 5, 10 g inulin

Group Type EXPERIMENTAL

Inulin Fiber Supplement

Intervention Type DIETARY_SUPPLEMENT

Orange juice fortified with 0, 5g, and 10g of 2 inulin products

Interventions

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Inulin Fiber Supplement

Orange juice fortified with 0, 5g, and 10g of 2 inulin products

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cargill

INDUSTRY

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne L Slavin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota: Nutrition and Food Science Department

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0805M32121

Identifier Type: -

Identifier Source: org_study_id

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