Dietary FiberNCT01321736
Gut Health Response to Dietary Fiber
A study testing dietary fiber in people with Dietary Fiber, run by University of Minnesota at 1 site in United States.
Trial summary
Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Fiber
- What is being tested?
- dietary fiber
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Weight
- BMI between 23 - 29
- having obtained his/her informed consent
- willing and able to exclusively consume enteral diets for two 14 day periods
- willing and able to collect stool samples as instructed
Who cannot join
- any disease
- use of medication except for contraceptive medication and certain OTC medications not affecting laxation
- smoking
- excessive exercise (> 2 hours per week)
- consumption of more than 20 grams of dietary fiber daily
- pregnancy or lactation
Show all 13Show fewer
- use of laxatives
- use of antibiotics in past 6 months
- use of pre or probiotics supplements in the past 2 months
- use of probiotic foods in the past month
- subjects who cannot be expected to comply with the study procedures
- currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- known allergy or sensitivity to formula ingredients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: Gut Health Response to a New Fiber Blend
Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.
Read the detailed description
Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.
- Conditions
- Dietary Fiber
- Being tested
- dietary fiber
- Keywords
- dietary fiber, enteral nutrition, laxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiberDietary supplement
Also called mixed fibers include fructans, soluble fiber, and insoluble fiber
mixture of fiber sources added to liquid nutrition product
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool weight
5 day fecal collection on last 5 days of 14 day feeding trial
Measured: 5 day collection
Secondary outcomes (1)
fecal microbiota
fecal sample on last day of feeding trial will be collected for microbiota analysis
Measured: day 14 of feeding trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 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 Dietary FiberStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321736
- Sponsor's protocol ID
- 1103M96878
- Status last verified
- Dec 2013
- First submitted
- 22 Mar 2011
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Koecher KJ, Thomas W, Slavin JL. Healthy subjects experience bowel changes on enteral diets: addition of a fiber blend attenuates stool weight and gut bacteria decreases without changes in gas. JPEN J Parenter Enteral Nutr. 2015 Mar;39(3):337-43. doi: 10.1177/0148607113510523. Epub 2013 Nov 14.
PubMed 24233256
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Health Response to a New Fiber Blend
- ClinicalTrials.gov ID
- NCT01321736
- Acronym / sponsor ID
- 1103M96878
- Conditions
- Dietary Fiber
- Keywords
- dietary fiber, enteral nutrition, laxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Mar 2011 (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 fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.
Detailed description
Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Weight
- BMI between 23 - 29
- having obtained his/her informed consent
- willing and able to exclusively consume enteral diets for two 14 day periods
- willing and able to collect stool samples as instructed
Key exclusion criteria (13 listed)
- any disease
- use of medication except for contraceptive medication and certain OTC medications not affecting laxation
- smoking
- excessive exercise (> 2 hours per week)
- consumption of more than 20 grams of dietary fiber daily
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 fiberAlso: mixed fibers include fructans, soluble fiber, and insoluble fibermixture of fiber sources added to liquid nutrition product | Dietary supplement | – |
Primary outcome
Stool weight
Time frame: 5 day collection
5 day fecal collection on last 5 days of 14 day feeding trial
1 secondary outcome
fecal microbiota
Time frame: day 14 of feeding trial
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 Dec 2013.
- Derived from this study: PubMed 24233256Koecher KJ, Thomas W, Slavin JL. Healthy subjects experience bowel changes on enteral diets: addition of a fiber blend attenuates stool weight and gut bacteria decreases without changes in gas. JPEN J Parenter Enteral Nutr. 2015 Mar;39(3):337-43. doi: 10.1177/0148607113510523. Epub 2013 Nov 14.
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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 Dietary Fiber, 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 5 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 6 Dec 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?
Stool weight (time frame: 5 day collection). 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 NCT01321736, 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 Dec 2013.