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Chicory Fiber Effect on Satiety and GI Tolerance

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ClinicalTrials.gov Identifier: NCT04067362
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The investigators are comparing 2 fiber treatments to a fiber free treatment for acute satiety and GI response.

Condition or disease Intervention/treatment Phase
Diet, Healthy Other: food containing dietary fiber Not Applicable

Detailed Description:
The investigators are measuring satiety and GI response after subjects consume 3 acute breakfast meals: 1. fiber-free control; 2. chicory root flour containing inulin; 3. inulin fiber supplement. After breakfast, subjects will complete subjective satiety instruments and describe any GI symptoms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of 2 Inulin Sources on Satiety and Gastrointestinal Tolerance
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Placebo Comparator: no fiber
Breakfast with hot chocolate with no fiber
Other: food containing dietary fiber
commercially available chicory root flour and chicory root fiber

Experimental: chicory root flour
Breakfast with hot chocolate with chicory root flour
Other: food containing dietary fiber
commercially available chicory root flour and chicory root fiber

Experimental: chicory root fiber supplement
Breakfast with hot chocolate with chicory root fiber supplement
Other: food containing dietary fiber
commercially available chicory root flour and chicory root fiber




Primary Outcome Measures :
  1. satiety [ Time Frame: 2 hours ]
    subjective instrument to assess how full you feel


Secondary Outcome Measures :
  1. Gastrointestinal response [ Time Frame: 24 hours ]
    subjective description of any GI symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

no food allergies; healthy; willing to consume breakfast in laboratory setting; usual low fiber diet;

Exclusion Criteria:

smokers, taking dietary supplements containing fiber

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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): NCT04067362


Locations
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United States, Minnesota
University of Minnesota Recruiting
Saint Paul, Minnesota, United States, 55108
Contact: Joanne L Slavin, PhD    612-624-7234    jslavin@umn.edu   
Principal Investigator: Joanne L Slavin, PhD         
Sponsors and Collaborators
University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04067362     History of Changes
Other Study ID Numbers: STUDY000179126
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No