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Gastrointestinal Toleration of Inulin Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00958529
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Healthy Dietary Supplement: Inulin Fiber Supplement

Detailed Description:
0, 5, and 10 grams of inulin

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance
Study Start Date : August 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: inulin
0, 5, 10 g inulin
Dietary Supplement: Inulin Fiber Supplement
Orange juice fortified with 0, 5g, and 10g of 2 inulin products


Outcome Measures

Primary Outcome Measures :
  1. Gastrointestinal Tolerance Score [ Time Frame: Aug 2008 thru Oct 2008 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958529


Locations
United States, Minnesota
University of Minnesota: Nutrition and Food Science Department
Minneapolis, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Cargill
Investigators
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00958529     History of Changes
Other Study ID Numbers: 0805M32121
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
fiber
inulin
gastrointestinal tolerance