- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560000
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite
March 13, 2013 updated by: University of Minnesota
The objective of this study is to determine the satiety value of different bran fibers on appetite & subsequent food intake with acute consumption.
Satiety will be measured subjectively by visual analogue scales (VAS).
Study Overview
Detailed Description
Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55108
- University of Minnesota
-
-
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 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- healthy women between the ages of 18-40
- body mass index between 18.5-29.9kg/m2
- eat breakfast regularly
- nonsmoking
- not taking weight loss medications
- non-dieting (weight stable over the past 3 months)
- spoken and written English literacy.
Exclusion Criteria:
- antibiotic use within the past 6 months
- cardiovascular disease
- diabetes mellitus
- cancer in the past 5 years
- renal or hepatic disease
- recent bacterial infection
- gastrointestinal conditions affecting digestion or absorption
- weight loss>5kg in prior 3 months (intentional or unintentional)
- history of drug or alcohol abuse in prior 6 months
- food allergies
- high fiber intake(3 or more servings of high fiber foods per day)
- lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
- restrained eater(score>10 on the dietary restraint factor of the Three Factor Eating Questionnaire)
- concurrent or recent (within 30 days) participation in an intervention study.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: fiber
|
Wheat, barley, oat and bran fibers added to a breakfast product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Satiety response
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (Estimate)
March 21, 2012
Study Record Updates
Last Update Posted (Estimate)
March 15, 2013
Last Update Submitted That Met QC Criteria
March 13, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 1202E10321
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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