Chicory Fiber Effect on Satiety and GI Tolerance

The Effects of 2 Inulin Sources on Satiety and Gastrointestinal Tolerance

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

Study Overview

• Status: Terminated
• Conditions: Diet, Healthy
• Intervention / Treatment: Other: food containing dietary fiber

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satiety	subjective instrument to assess how full you feel	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal response	subjective description of any GI symptoms	24 hours

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (ACTUAL): August 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY000179126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No