Feeding BehaviorNCT02689791
Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults
A study testing Resistant Starch Type 4 in people with Feeding Behavior, run by Iowa State University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- Resistant Starch Type 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-29.9 kg/m2
- Regular breakfast consumers (>5 days/week)
Who cannot join
- 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)
About this study
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.
- Conditions
- Feeding Behavior
- Being tested
- Resistant Starch Type 4
- Keywords
- Appetite, Food Intake, Satiety Hormones
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Starch Type 4Dietary supplement
Also called Fibersym
single dose 26g fiber given at the breakfast meal
| Study group | Role | What they receive |
|---|---|---|
| Control (SWF) | No intervention | Standard Wheat Flour (SWF) Muffins |
| Resistant Starch Type 4 | Experimental | Resistant Wheat Starch Muffins Receives: Dietary Supplement: Resistant Starch Type 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake
calories consumed at post-treatment lunch meal and total calories consumed on the treatment day
Measured: Single Day
Secondary outcomes (3)
Visual analogue scale measures of subjective appetite
0-100mm scale to assess hunger, fullness, thirst, desire to eat and prospective consumption
Measured: Single Day
Serum concentrations of biomarkers of appetite
CCK, ghrelin, PYY3-36 and GLP-1
Measured: 150 minutes
Plasma concentrations of biomarkers of glycemic response
Glucose, Insulin, GLP-1
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Hollis, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689791
- Sponsor's protocol ID
- IowaSU
- Status last verified
- Feb 2016
- First submitted
- 7 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults
- ClinicalTrials.gov ID
- NCT02689791
- Acronym / sponsor ID
- IowaSU
- Conditions
- Feeding Behavior
- Keywords
- Appetite, Food Intake, Satiety Hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (SWF) | No intervention | –Standard Wheat Flour (SWF) Muffins |
| Resistant Starch Type 4 | Experimental | Dietary Supplement: Resistant Starch Type 4Resistant Wheat Starch Muffins |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5-29.9 kg/m2
- Regular breakfast consumers (>5 days/week)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant Starch Type 4Also: Fibersymsingle dose 26g fiber given at the breakfast meal | Dietary supplement | Resistant Starch Type 4 |
Primary outcome
Caloric intake
Time frame: Single Day
calories consumed at post-treatment lunch meal and total calories consumed on the treatment day
3 secondary outcomes
Visual analogue scale measures of subjective appetite
Time frame: Single Day
Serum concentrations of biomarkers of appetite
Time frame: 150 minutes
Plasma concentrations of biomarkers of glycemic response
Time frame: 150 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Feeding Behavior
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch Type 4 in people with Feeding Behavior, run by Iowa State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric intake (time frame: Single Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.