HealthyEarly Phase 1NCT01233024
Satiety Response of Four Dietary Fibers
A Early Phase 1 study testing Soluble corn fiber, Resistant starch and Fructooligosaccharide in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine. 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
- Healthy
- What is being tested?
- Soluble corn fiber, Resistant starch and Fructooligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2012
- Phase
- Early Phase 1
- 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
- Age 18-40 years
- Nonsmoking
- Not taking weight loss medications
- Non-dieting (weight has not changed more than 11 pounds over three months)
- BMI between 18.5 and 29
- Spoken and written English literacy
Who cannot join
- Do not regularly consume breakfast
- Food allergies to wheat, soy, peanut, or dairy
- BMI less than 25 or greater than 29 upon admission to study
- Cancer diagnosis in past 5 years
- History of heart disease, kidney disease, diabetes, or eating disorder
- History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition
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- History of drug or alcohol abuse in past 6 months
- Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
- Concurrent or recent (within 30 days) intervention study participation
- Pregnant or lactating
- Irregular menstrual cycle
- Vegetarians
- People who eat more than approximately 15 grams of fiber per day
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation
Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.
The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.
- Conditions
- Healthy
- Being tested
- Control, Soluble corn fiber, Resistant starch, Fructooligosaccharide, Inulin
- Keywords
- Adult, Women, Dietary Fiber, Satiety Response, Food Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Also called Low fiber control
Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.
Soluble corn fiberDietary supplement
Also called Promitor soluble corn fiber
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Resistant starchDietary supplement
Also called FiberSym resistant starch
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
FructooligosaccharideDietary supplement
Also called Orafti P95 fructooligosaccharide
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
InulinDietary supplement
Also called Orafti HPX inulin
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
| Study group | Role | What they receive |
|---|---|---|
| Low fiber control | Placebo comparator | no treatment dinner bar, no treatment breakfast bar Receives: Dietary Supplement: Control |
| Promitor soluble corn fiber | Experimental | 12g in dinner bar, 11g in breakfast bar Receives: Dietary Supplement: Soluble corn fiber |
| FiberSym resistant starch | Experimental | 12g in dinner bar, 11g breakfast bar Receives: Dietary Supplement: Resistant starch |
| Orafti P95 fructooligosaccharide | Experimental | 12g in dinner bar, 11g in breakfast bar Receives: Dietary Supplement: Fructooligosaccharide |
| Orafti HPX inulin | Experimental | 12g in dinner bar, 11g in breakfast bar Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety response using visual analogue scales
Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Secondary outcomes (3)
Food intake
Measured: 180 minutes postprandially and over 24 hours
Breath hydrogen response
Measured: 0 and 180 minutes
Gastrointestinal tolerance using visual analogue scales (VAS)
Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS. A stool count will also be recorded.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233024
- Sponsor's protocol ID
- 1003E78714
- Status last verified
- Mar 2012
- First submitted
- 28 May 2010
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation
- ClinicalTrials.gov ID
- NCT01233024
- Acronym / sponsor ID
- 1003E78714
- Conditions
- Healthy
- Keywords
- Adult, Women, Dietary Fiber, Satiety Response, Food Intake
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Nov 2010 (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.
Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.
The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low fiber control | Placebo comparator | Dietary Supplement: Controlno treatment dinner bar, no treatment breakfast bar |
| Promitor soluble corn fiber | Experimental | Dietary Supplement: Soluble corn fiber12g in dinner bar, 11g in breakfast bar |
| FiberSym resistant starch | Experimental | Dietary Supplement: Resistant starch12g in dinner bar, 11g breakfast bar |
| Orafti P95 fructooligosaccharide | Experimental | Dietary Supplement: Fructooligosaccharide12g in dinner bar, 11g in breakfast bar |
| Orafti HPX inulin | Experimental | Dietary Supplement: Inulin12g in dinner bar, 11g in breakfast bar |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy women
- Age 18-40 years
- Nonsmoking
- Not taking weight loss medications
- Non-dieting (weight has not changed more than 11 pounds over three months)
Key exclusion criteria (13 listed)
- Do not regularly consume breakfast
- Food allergies to wheat, soy, peanut, or dairy
- BMI less than 25 or greater than 29 upon admission to study
- Cancer diagnosis in past 5 years
- History of heart disease, kidney disease, diabetes, or eating disorder
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 |
|---|---|---|
| ControlAlso: Low fiber controlDinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber. | Dietary supplement | Low fiber control |
| Soluble corn fiberAlso: Promitor soluble corn fiberDinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber. | Dietary supplement | Promitor soluble corn fiber |
| Resistant starchAlso: FiberSym resistant starchDinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber. | Dietary supplement | FiberSym resistant starch |
| FructooligosaccharideAlso: Orafti P95 fructooligosaccharideDinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber. | Dietary supplement | Orafti P95 fructooligosaccharide |
| InulinAlso: Orafti HPX inulinDinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber. | Dietary supplement | Orafti HPX inulin |
Primary outcome
Satiety response using visual analogue scales
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
3 secondary outcomes
Food intake
Time frame: 180 minutes postprandially and over 24 hours
Breath hydrogen response
Time frame: 0 and 180 minutes
Gastrointestinal tolerance using visual analogue scales (VAS)
Time frame: 24 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 29 Mar 2012.
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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 L 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 Early Phase 1 study testing Soluble corn fiber, Resistant starch and Fructooligosaccharide in people with Healthy, 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 13 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 29 Mar 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 using visual analogue scales (time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially). 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 29 Mar 2012.