- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02689791
Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults
February 18, 2016 updated by: James Hollis, Iowa State University
A randomized, single-blind, cross-over study was conducted to determine the effect of replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite and food intake in healthy adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 18.5-29.9 kg/m2
- Regular breakfast consumers (>5 days/week)
Exclusion Criteria:
- not weight stable (?3 kg weight change in previous 3 months)
- use/used tobacco products
- presence of acute or chronic illness
- restrained eater (>13 on the restraint section of the three-factor eating questionnaire)
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
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control (SWF)
Standard Wheat Flour (SWF) Muffins
|
|
|
Experimental: Resistant Starch Type 4
Resistant Wheat Starch Muffins
|
single dose 26g fiber given at the breakfast meal
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caloric intake
Time Frame: Single Day
|
calories consumed at post-treatment lunch meal and total calories consumed on the treatment day
|
Single Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale measures of subjective appetite
Time Frame: Single Day
|
0-100mm scale to assess hunger, fullness, thirst, desire to eat and prospective consumption
|
Single Day
|
|
Serum concentrations of biomarkers of appetite
Time Frame: 150 minutes
|
CCK, ghrelin, PYY3-36 and GLP-1
|
150 minutes
|
|
Plasma concentrations of biomarkers of glycemic response
Time Frame: 150 minutes
|
Glucose, Insulin, GLP-1
|
150 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
February 7, 2016
First Submitted That Met QC Criteria
February 18, 2016
First Posted (Estimate)
February 24, 2016
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IowaSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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