FoodNCT01560000
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite
A study testing Dietary fiber in people with Food, run by University of Minnesota at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food
- What is being tested?
- Dietary fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2012
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- antibiotic use within the past 6 months
- cardiovascular disease
- diabetes mellitus
- cancer in the past 5 years
- renal or hepatic disease
- recent bacterial infection
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
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).
Read the detailed description
Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes
- Conditions
- Food
- Being tested
- Dietary fiber
- Keywords
- The focus of this study is to determine satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fiberDietary supplement
Wheat, barley, oat and bran fibers added to a breakfast product
| Study group | Role | What they receive |
|---|---|---|
| fiber | Other | Not described Receives: Dietary Supplement: Dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety response
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FoodStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560000
- Sponsor's protocol ID
- 1202E10321
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2012
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Korczak R, Lindeman K, Thomas W, Slavin JL. Bran fibers and satiety in women who do not exhibit restrained eating. Appetite. 2014 Sep;80:257-63. doi: 10.1016/j.appet.2014.05.025. Epub 2014 May 27.
PubMed 24874565
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite
- ClinicalTrials.gov ID
- NCT01560000
- Acronym / sponsor ID
- 1202E10321
- Conditions
- Food
- Keywords
- The focus of this study is to determine satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Mar 2012 (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.
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).
Detailed description
Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fiber | Other | Dietary Supplement: Dietary fiber |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- antibiotic use within the past 6 months
- cardiovascular disease
- diabetes mellitus
- cancer in the past 5 years
- renal or hepatic disease
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 |
|---|---|---|
| Dietary fiberWheat, barley, oat and bran fibers added to a breakfast product | Dietary supplement | fiber |
Primary outcome
Satiety response
Time frame: 4 hours
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 15 Mar 2013.
- Derived from this study: PubMed 24874565Korczak R, Lindeman K, Thomas W, Slavin JL. Bran fibers and satiety in women who do not exhibit restrained eating. Appetite. 2014 Sep;80:257-63. doi: 10.1016/j.appet.2014.05.025. Epub 2014 May 27.
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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.
Joanne Slavin, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fiber in people with Food, run by University of Minnesota at 1 site in United States.
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 7 inclusion and 14 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Satiety response (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01560000, which also lists 1 linked publication.
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 15 Mar 2013.