NCT04067362

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

August 21, 2019

Last Update Submit

October 5, 2020

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (1)

  • satiety

    subjective instrument to assess how full you feel

    2 hours

Secondary Outcomes (1)

  • Gastrointestinal response

    24 hours

Study Arms (3)

no fiber

PLACEBO COMPARATOR

Breakfast with hot chocolate with no fiber

Other: food containing dietary fiber

chicory root flour

EXPERIMENTAL

Breakfast with hot chocolate with chicory root flour

Other: food containing dietary fiber

chicory root fiber supplement

EXPERIMENTAL

Breakfast with hot chocolate with chicory root fiber supplement

Other: food containing dietary fiber

Interventions

food containing dietary fiberOTHER

commercially available chicory root flour and chicory root fiber

chicory root fiber supplementchicory root flourno fiber

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • smokers, taking dietary supplements containing fiber

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

September 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)