ToleranceNCT02091349
Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber
A study testing polydextrose and soluble corn fiber in people with Tolerance, run by University of Illinois at Urbana-Champaign.
Trial summary
The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tolerance
- What is being tested?
- polydextrose and soluble corn fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- have body mass index (BMI) between 18.5 and 31 kg/m2
- free of metabolic and gastrointestinal disease
Who cannot join
- BMI less than 18.5 or greater than 31 kg/m2
- presence of metabolic or gastrointestinal diseases
About this study
The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.
Read the detailed description
Soluble fibers have been shown to have many positive effects in humans, including laxation and maintaining gastrointestinal health. It is expected that feeding soluble fibers will decrease protein fermentative end=products while increasing carbohydrate fermenative end-products, and lead to a more beneficial microbial profile. Determination of the effects of nutriose and polydextrose when included as supplemental fiber in a human diet will give insights to its potential to maintain or improve gut health and highlight its use in the food industry.
The object of this study are first to determine the tolerance of soluble fibers polydextrose, inulin and nutriose when provided as supplemental fiber to an existing diet. The second objective is to determine the utilization of polydextrose and nutriose through analyses of fecal samples of fermentative end-products and shifts in microbial populations.
- Conditions
- Tolerance
- Being tested
- polydextrose, soluble corn fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polydextroseOther
polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods
soluble corn fiberOther
nutirose- 7, 14, or 21 grams/day
| Study group | Role | What they receive |
|---|---|---|
| Group A- placebo | Placebo comparator | control- snack bar or muffin containing no fiber Receives: Other: polydextrose; Other: soluble corn fiber |
| Group B- polydextrose | Experimental | polydextrose- randomly bonded polysaccharide of glucose which is poorly digested in small intestine Receives: Other: polydextrose; Other: soluble corn fiber |
| Group C- soluble corn fiber | Experimental | Soluble corn fiber made from corn starch and contains oligosaccharides with random glyucosyl bonds and may contain minor amounts of monosaccharides Receives: Other: polydextrose; Other: soluble corn fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal bacteria
Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for analysis of bacterial species present.
Measured: Days 16-21 of each treatment period
Fecal fermentation end products
Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for fermentation end product analysis (short-chain fatty indoles, ammonia) and dry matter.
Measured: Days 16-21 of each treatment period
Secondary outcomes (2)
Gastrointestinal Tolerance
Gastrointestinal tolerance was scored using the following scale: 1=absent, 2=mild, 3=moderate, 4=severe. All study participants booklets with daily tolerance questionnaires in them. The participants will complete the questionnaires on their own each day.
Measured: Daily during each 21 day treatment period
Daily Stool Characteristics
Participants are provided a journal to complete on their own each day, a questionnaire about their stool characteristics. Participants were score the ease of stool passage using the following scale: 1=very easy, 2=easy, 3=neither easy nor difficult, 4=difficult, 5=very difficult.
Stool consistency was scored using the Bristol stool scale: 1=separate hard lumps, like nuts; 2=sausage-shaped but lumpy; 3=like a sausage cracks on surface; 4=Like a sausage or snake, smooth and soft; 5=soft blobs with clear-cut edges; 6=fluffy pieces with ragged edges, 7=watery, no solid pieces, entirely liquid.
Measured: Daily during each 21 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJul 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 ToleranceStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Fahey, Jr, PhD, Principal investigator, UIUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091349
- Sponsor's protocol ID
- 09491
- Status last verified
- May 2014
- First submitted
- 17 Mar 2014
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Holscher HD, Caporaso JG, Hooda S, Brulc JM, Fahey GC Jr, Swanson KS. Fiber supplementation influences phylogenetic structure and functional capacity of the human intestinal microbiome: follow-up of a randomized controlled trial. Am J Clin Nutr. 2015 Jan;101(1):55-64. doi: 10.3945/ajcn.114.092064. Epub 2014 Nov 12.
PubMed 25527750
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber
- ClinicalTrials.gov ID
- NCT02091349
- Acronym / sponsor ID
- 09491
- Conditions
- Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Mar 2014 (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 tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.
Detailed description
Soluble fibers have been shown to have many positive effects in humans, including laxation and maintaining gastrointestinal health. It is expected that feeding soluble fibers will decrease protein fermentative end=products while increasing carbohydrate fermenative end-products, and lead to a more beneficial microbial profile. Determination of the effects of nutriose and polydextrose when included as supplemental fiber in a human diet will give insights to its potential to maintain or improve gut health and highlight its use in the food industry.
The object of this study are first to determine the tolerance of soluble fibers polydextrose, inulin and nutriose when provided as supplemental fiber to an existing diet. The second objective is to determine the utilization of polydextrose and nutriose through analyses of fecal samples of fermentative end-products and shifts in microbial populations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A- placebo | Placebo comparator | Other: polydextrose, Other: soluble corn fibercontrol- snack bar or muffin containing no fiber |
| Group B- polydextrose | Experimental | Other: polydextrose, Other: soluble corn fiberpolydextrose- randomly bonded polysaccharide of glucose which is poorly digested in small intestine |
| Group C- soluble corn fiber | Experimental | Other: polydextrose, Other: soluble corn fiberSoluble corn fiber made from corn starch and contains oligosaccharides with random glyucosyl bonds and may contain minor amounts of monosaccharides |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- have body mass index (BMI) between 18.5 and 31 kg/m2
- free of metabolic and gastrointestinal disease
Key exclusion criteria (2 listed)
- BMI less than 18.5 or greater than 31 kg/m2
- presence of metabolic or gastrointestinal diseases
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 |
|---|---|---|
| polydextrosepolydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods | Other | Group A- placebo, Group B- polydextrose, Group C- soluble corn fiber |
| soluble corn fibernutirose- 7, 14, or 21 grams/day | Other | Group A- placebo, Group B- polydextrose, Group C- soluble corn fiber |
Primary outcome
Fecal bacteria
Time frame: Days 16-21 of each treatment period
Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for analysis of bacterial species present.
Fecal fermentation end products
Time frame: Days 16-21 of each treatment period
Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for fermentation end product analysis (short-chain fatty indoles, ammonia) and dry matter.
2 secondary outcomes
Gastrointestinal Tolerance
Time frame: Daily during each 21 day treatment period
Daily Stool Characteristics
Time frame: Daily during each 21 day treatment period
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 14 May 2014.
- Derived from this study: PubMed 25527750Holscher HD, Caporaso JG, Hooda S, Brulc JM, Fahey GC Jr, Swanson KS. Fiber supplementation influences phylogenetic structure and functional capacity of the human intestinal microbiome: follow-up of a randomized controlled trial. Am J Clin Nutr. 2015 Jan;101(1):55-64. doi: 10.3945/ajcn.114.092064. Epub 2014 Nov 12.
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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.
George Fahey, Jr, PhD principal investigator
UIUC
Questions about this trial
What is this clinical trial studying?
A study testing polydextrose and soluble corn fiber in people with Tolerance, run by University of Illinois at Urbana-Champaign.
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 2 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 14 May 2014. 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. 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?
Fecal bacteria (time frame: Days 16-21 of each treatment period). The study lists 2 primary outcomes in all. 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 NCT02091349, 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 14 May 2014.