HealthyNCT00958399
Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
A study testing Resistant Starch, Resistant starch + soluble fiber and Fiber made from corn starch in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Resistant Starch, Resistant starch + soluble fiber and Fiber made from corn starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
- age 18-60 years
- non-smoking
- not taking medication
- non-dieting (weight stable in prior 3 months)
- BMI 18-27
- English literacy
- ability to give blood
Who cannot join
- do not regularly consume breakfast
- food allergies to ingredients found in study products
- dislike for muffins, fiber bars, or hot cereal
- BMI <18 or >27
- diagnosed cardiovascular, renal, or hepatic disease
- diabetes mellitus (fasting blood sugar >126 mg/dl)
Show all 17Show 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 medication
- restrained eaters
- vegetarians
- people who eat more than approximately 15 grams of fiber per day
- women who are pregnant or lactating
- women with irregular menstrual cycles
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - General Clinical Research Center
Minneapolis, Minnesota, 55455
About this study
Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.
The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.
- Conditions
- Healthy
- Being tested
- Placebo, Resistant Starch, Resistant starch + soluble fiber, Fiber made from corn starch, Fiber made from corn starch + soluble fiber
- Keywords
- satiety, fiber, food intake, gut hormones, visual analog scales, microflora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Resistant StarchDietary supplement
25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Resistant starch + soluble fiberDietary supplement
25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Fiber made from corn starchDietary supplement
25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Fiber made from corn starch + soluble fiberDietary supplement
25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
| Study group | Role | What they receive |
|---|---|---|
| No fiber | Placebo comparator | No fiber added to study products Receives: Dietary Supplement: Placebo |
| Resistant Starch | Experimental | Muffins, cereal, and bars made with a resistant starch Receives: Dietary Supplement: Resistant Starch |
| Resistant starch + soluble fiber | Experimental | Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber Receives: Dietary Supplement: Resistant starch + soluble fiber |
| Fiber made from corn starch | Experimental | Muffins, cereal, and bars made with novel corn fiber Receives: Dietary Supplement: Fiber made from corn starch |
| Fiber made from corn starch + soluble fiber | Experimental | Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber Receives: Dietary Supplement: Fiber made from corn starch + soluble fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety
Measured: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially
Secondary outcomes (4)
ad libitum food intake
Measured: 180 minutes postprandially and over 24 hours
Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response
Measured: 0, 30, 60 minutes postprandially
Gastrointestinal tolerance and fecal chemistry
Measured: following 7 days of treatment
Glucose/Insulin Response
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2010
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Tate and Lyle Ingredients France
- Responsible party
- Sponsor
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958399
- Sponsor's protocol ID
- 0701M00264
- Status last verified
- Feb 2012
- First submitted
- 12 Aug 2009
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20.
PubMed 23427334
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
- ClinicalTrials.gov ID
- NCT00958399
- Acronym / sponsor ID
- 0701M00264
- Conditions
- Healthy
- Keywords
- satiety, fiber, food intake, gut hormones, visual analog scales, microflora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Tate and Lyle Ingredients France
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Aug 2009 (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.
Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.
The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No fiber | Placebo comparator | Dietary Supplement: PlaceboNo fiber added to study products |
| Resistant Starch | Experimental | Dietary Supplement: Resistant StarchMuffins, cereal, and bars made with a resistant starch |
| Resistant starch + soluble fiber | Experimental | Dietary Supplement: Resistant starch + soluble fiberMuffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber |
| Fiber made from corn starch | Experimental | Dietary Supplement: Fiber made from corn starchMuffins, cereal, and bars made with novel corn fiber |
| Fiber made from corn starch + soluble fiber | Experimental | Dietary Supplement: Fiber made from corn starch + soluble fiberMuffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- healthy men and women
- age 18-60 years
- non-smoking
- not taking medication
- non-dieting (weight stable in prior 3 months)
Key exclusion criteria (17 listed)
- do not regularly consume breakfast
- food allergies to ingredients found in study products
- dislike for muffins, fiber bars, or hot cereal
- BMI <18 or >27
- diagnosed 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 |
|---|---|---|
| PlaceboLow fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase) | Dietary supplement | No fiber |
| Resistant Starch25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase) | Dietary supplement | Resistant Starch |
| Resistant starch + soluble fiber25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase) | Dietary supplement | Resistant starch + soluble fiber |
| Fiber made from corn starch25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase) | Dietary supplement | Fiber made from corn starch |
| Fiber made from corn starch + soluble fiber25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase) | Dietary supplement | Fiber made from corn starch + soluble fiber |
Primary outcome
Satiety
Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially
4 secondary outcomes
ad libitum food intake
Time frame: 180 minutes postprandially and over 24 hours
Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response
Time frame: 0, 30, 60 minutes postprandially
Gastrointestinal tolerance and fecal chemistry
Time frame: following 7 days of treatment
Glucose/Insulin Response
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
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 6 Feb 2012.
- Derived from this study: PubMed 23427334Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20.
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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 Resistant Starch, Resistant starch + soluble 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 8 inclusion and 17 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 6 Feb 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.
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 (time frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially). 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 NCT00958399, 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 6 Feb 2012.