- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958529
Gastrointestinal Toleration of Inulin Products
February 9, 2017 updated by: University of Minnesota
Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
0, 5, and 10 grams of inulin
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55108
- University of Minnesota: Nutrition and Food Science Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: inulin
0, 5, 10 g inulin
|
Orange juice fortified with 0, 5g, and 10g of 2 inulin products
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gastrointestinal Tolerance Score
Time Frame: Aug 2008 thru Oct 2008
|
Aug 2008 thru Oct 2008
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joanne L Slavin, PhD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
August 12, 2009
First Submitted That Met QC Criteria
August 12, 2009
First Posted (Estimate)
August 13, 2009
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0805M32121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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