HealthyNCT01102881
Laxation and Satiety Response of Novel Dietary Fibers
A study testing Glucose polymer fiber and Fiber made from corn starch in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glucose polymer fiber and Fiber made from corn starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men and women
- age 18-65
- non-smoking
- not taking medication
- non-dieting (weight stable in prior 3 months)
- BMI 18-30
- English literacy
Who cannot join
- do not regularly consume breakfast
- food allergies to ingredients found in study product
- dislike of cereal or muffins
- BMI <18 or >30
- diagnosed with cardiovascular, renal, or hepatic disease
- diabetes mellitus (fasting blood glucose > 126 mg/ml)
Show all 12Show fewer
- cancer in previous 5 years (except basal cell carcinoma of the skin)
- any gastrointestinal disease or condition
- recent bacterial infection (< 3 months)
- recent or concurrent participation in an intervention research study
- history of drug or alcohol abuse in prior 6 months
- use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medications vegetarians people who eat more than approximately 15 grams of dietary fiber per day women who are pregnant or lactating women with irregular menstrual cycles consumption of prebiotics or probiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Therefore as new dietary fibers are created or discovered the laxative and satiating effects should be investigated in order to verify these effects.
Read the detailed description
This study was designed to test the laxative effects of two fibers a resistant starch made from corn and a glucose polymer fiber. The secondary aim of this study was to examine the satieting effects of these fibers. This trial was double-blind and placebo controlled. On the first day of the study subjects consumed the breakfast cereal and milk and were instructed to complete visual analog scales periodically to test acute satiety. Subjects also completed diet records and tolerance questionnaires on days 1,2, and 10. Additionally subjects completed another satiety survey on day 10 to test chronic satiety. Whole gut transit time, fecal weight, and fecal chemistry was tested by swallowing radioopaque pellets on day 6 and collecting every fecal sample for the 5 days thereafter.
- Conditions
- Healthy
- Being tested
- Glucose polymer fiber, Fiber made from corn starch, placebo
- Keywords
- Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose polymer fiberDietary supplement
20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin
Fiber made from corn starchDietary supplement
Also called Dietary fiber made from corn starch
20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin
placeboDietary supplement
low fiber breakfast cereal and muffin
| Study group | Role | What they receive |
|---|---|---|
| No fiber | Placebo comparator | No fiber added to muffins or cereal Receives: Dietary Supplement: placebo |
| Fiber made from corn starch | Experimental | Muffins and cereal made with novel corn fiber Receives: Dietary Supplement: Fiber made from corn starch |
| Glucose polymer fiber | Experimental | Muffins and cereal made from glucose polymer fiber Receives: Dietary Supplement: Glucose polymer fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time determined by radio-opaque pellets
Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets
Measured: 5 day fecal collection
Secondary outcomes (5)
Satiety
Measure hunger, fullness, satisfaction, and prospective food consumption using a 100 mm line
Measured: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially
Breath Hydrogen concentration after consumption of test cereal
Subjects expel air into a storage bag, which is then injected into a gas chromatograph and determine the hydrogen concentration. Hydrogen gas is an indicator of fermentation in the large intestine.
Measured: 0 and 240 minutes postprandially
Ad libitum food intake
24 hour food diary
Measured: 24 hours, 48 hours, and 10 days after the start of treatment
Gastrointestinal Tolerance
Rank severity of flatuence, bloating, abdominal cramps, stomach noises, nausea, diarrhea, and constipation on a 10 point scale.
Measured: 24 hours, 48 hours, and 10 days after the start of the treatment
Fecal chemistry
Determination of fecal pH and short-chain fatty acid concentration
Measured: 6-10 days after the start of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Tate and Lyle Ingredients France, General Mills
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102881
- Sponsor's protocol ID
- 0902M60241
- Status last verified
- Sep 2010
- First submitted
- 23 Mar 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laxation and Satiety Response of Novel Dietary Fibers
- ClinicalTrials.gov ID
- NCT01102881
- Acronym / sponsor ID
- 0902M60241
- Conditions
- Healthy
- Keywords
- Healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Tate and Lyle Ingredients France, General Mills
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Apr 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.
Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Therefore as new dietary fibers are created or discovered the laxative and satiating effects should be investigated in order to verify these effects.
Detailed description
This study was designed to test the laxative effects of two fibers a resistant starch made from corn and a glucose polymer fiber. The secondary aim of this study was to examine the satieting effects of these fibers. This trial was double-blind and placebo controlled. On the first day of the study subjects consumed the breakfast cereal and milk and were instructed to complete visual analog scales periodically to test acute satiety. Subjects also completed diet records and tolerance questionnaires on days 1,2, and 10. Additionally subjects completed another satiety survey on day 10 to test chronic satiety. Whole gut transit time, fecal weight, and fecal chemistry was tested by swallowing radioopaque pellets on day 6 and collecting every fecal sample for the 5 days thereafter.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No fiber | Placebo comparator | Dietary Supplement: placeboNo fiber added to muffins or cereal |
| Fiber made from corn starch | Experimental | Dietary Supplement: Fiber made from corn starchMuffins and cereal made with novel corn fiber |
| Glucose polymer fiber | Experimental | Dietary Supplement: Glucose polymer fiberMuffins and cereal made from glucose polymer fiber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- healthy men and women
- age 18-65
- non-smoking
- not taking medication
- non-dieting (weight stable in prior 3 months)
Key exclusion criteria (12 listed)
- do not regularly consume breakfast
- food allergies to ingredients found in study product
- dislike of cereal or muffins
- BMI <18 or >30
- diagnosed with cardiovascular, 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 |
|---|---|---|
| Glucose polymer fiber20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin | Dietary supplement | Glucose polymer fiber |
| Fiber made from corn starchAlso: Dietary fiber made from corn starch20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin | Dietary supplement | Fiber made from corn starch |
| placebolow fiber breakfast cereal and muffin | Dietary supplement | No fiber |
Primary outcome
Whole gut transit time determined by radio-opaque pellets
Time frame: 5 day fecal collection
Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets
5 secondary outcomes
Satiety
Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially
Breath Hydrogen concentration after consumption of test cereal
Time frame: 0 and 240 minutes postprandially
Ad libitum food intake
Time frame: 24 hours, 48 hours, and 10 days after the start of treatment
Gastrointestinal Tolerance
Time frame: 24 hours, 48 hours, and 10 days after the start of the treatment
Fecal chemistry
Time frame: 6-10 days after the start of treatments
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 9 Sep 2010.
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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 study testing Glucose polymer fiber and Fiber made from corn starch 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 12 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 9 Sep 2010. 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.
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?
Whole gut transit time determined by radio-opaque pellets (time frame: 5 day fecal collection). 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 9 Sep 2010.