Gastrointestinal Toleration of Inulin Products

This study has been completed.
Sponsor:
Collaborator:
Cargill
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00958529
First received: August 12, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 Intervention
Healthy
Dietary Supplement: Inulin Fiber Supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Gastrointestinal Tolerance Score [ Time Frame: Aug 2008 thru Oct 2008 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Inulin Fiber Supplement
    Orange juice fortified with 0, 5g, and 10g of 2 inulin products
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Joanne Slavin, University of Minnesota
ClinicalTrials.gov Identifier: NCT00958529     History of Changes
Other Study ID Numbers: 0805M32121
Study First Received: August 12, 2009
Last Updated: August 12, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014