Chicory Fiber Effect on Satiety and GI Tolerance

• Sponsor: University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04067362
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 8
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual 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: Sep 1, 2019
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Apr 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. satiety [2 hours]

   subjective instrument to assess how full you feel

Secondary Outcome Measures

1. Gastrointestinal response [24 hours]

   subjective description of any GI symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Saint Paul	Minnesota	United States	55108

Sponsors and Collaborators

• University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04067362
• Other Study ID Numbers: STUDY000179126
• First Posted: Aug 26, 2019
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 8, 2020