- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588600
Effects of Fiber on Satiety
April 20, 2016 updated by: Ingredion Incorporated
Effects of Fiber on Satiety and Food Intake in Men and Women
The effects of a dietary fiber on hunger and food intake will be tested in men and women.
Participants will receive fiber as part of a breakfast meal on two occasions.
On another occasion, participants will receive the same breakfast, without added fiber.
Their feelings of hunger and fullness will be measured over the day.
They will be offered lunch, dinner and an evening snack and how much they eat will be recorded.
It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.
Study Overview
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
-
Liverpool, United Kingdom, L69 7ZA
- Kissileff Laboratory for the Study of Human Ingestive Behavior
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- normal-weight adults
Exclusion Criteria:
- eating disorders,
- on medications that affect food intake,
- pregnant or lactating,
- non-breakfast eaters
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Breakfast without fiber
|
Fiber added to breakfast
|
|
Experimental: Low-dose
Low-dose of fiber in breakfast
|
Fiber added to breakfast
|
|
Experimental: High-dose
high dose of fiber added to breakfast
|
Fiber added to breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake
Time Frame: 24-hr food intake, on three occasions within 3 weeks
|
24-hour Food intake will be measured 3 times
|
24-hr food intake, on three occasions within 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite ratings
Time Frame: Hourly, over 8 hrs, on 3 days within a 3-week period
|
Ratings of hunger and fullness will be assessed 18 times
|
Hourly, over 8 hrs, on 3 days within a 3-week period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason Halford, PhD, University of Liverpool
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
April 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
April 10, 2012
First Submitted That Met QC Criteria
April 27, 2012
First Posted (Estimate)
May 1, 2012
Study Record Updates
Last Update Posted (Estimate)
April 21, 2016
Last Update Submitted That Met QC Criteria
April 20, 2016
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UL001
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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