Gastrointestinal HealthNCT01495182
Effects of Dietary Fiber on Gastrointestinal Function
A study testing Dietary fiber in people with Gastrointestinal Health, run by Ingredion Incorporated at 1 site in United States.
Trial summary
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health
- What is being tested?
- Dietary fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
- age 18 - 54 years
- BMI < 30 kg/m2
Who cannot join
- presence of GI or other serious diseases known to affect GI function
- recent use of antibiotics
- very high fiber intake
- use of medications known to affect GI function
- presence of allergies to study foods
Trial locations and contacts
1 site in 1 country.
United States1 site
Provident Clinical Research and Consulting Inc
Glen Ellyn, Illinois, 60137
About this study
Official title: A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.
Read the detailed description
The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.
- Conditions
- Gastrointestinal Health
- Being tested
- Dietary fiber
- Keywords
- Dietary fiber, Gastrointestinal toleration, Fecal weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fiberOther
A proprietary fiber will be given to subjects
| Study group | Role | What they receive |
|---|---|---|
| Dietary Fiber - Dose 1 | Experimental | Dietary fiber will be added to study foods Receives: Other: Dietary fiber |
| Dietary Fiber - Dose 2 | Experimental | Dietary fiber will be added to study foods Receives: Other: Dietary fiber |
| Control | Active comparator | Study foods with no added fiber will be given Receives: Other: Dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerability
Questionnaire to assess symptoms such as nausea, bloating, and flatulence
Measured: subjects will report weekly for 6 weeks
Secondary outcomes (1)
Fecal output
Fecal weight and stool characteristics will be measured
Measured: subjects will collect fecal output for 12 days within a six-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredion Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Principal investigator, Provident Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495182
- Sponsor's protocol ID
- 002
- Status last verified
- Dec 2011
- First submitted
- 14 Dec 2011
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT01495182
- Acronym / sponsor ID
- 002
- Conditions
- Gastrointestinal Health
- Keywords
- Dietary fiber, Gastrointestinal toleration, Fecal weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ingredion IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Dec 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.
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.
Detailed description
The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Fiber - Dose 1 | Experimental | Other: Dietary fiberDietary fiber will be added to study foods |
| Dietary Fiber - Dose 2 | Experimental | Other: Dietary fiberDietary fiber will be added to study foods |
| Control | Active comparator | Other: Dietary fiberStudy foods with no added fiber will be given |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy men and women
- age 18 - 54 years
- BMI < 30 kg/m2
Key exclusion criteria (5 listed)
- presence of GI or other serious diseases known to affect GI function
- recent use of antibiotics
- very high fiber intake
- use of medications known to affect GI function
- presence of allergies to study foods
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 fiberA proprietary fiber will be given to subjects | Other | Control, Dietary Fiber - Dose 1, Dietary Fiber - Dose 2 |
Primary outcome
Gastrointestinal tolerability
Time frame: subjects will report weekly for 6 weeks
Questionnaire to assess symptoms such as nausea, bloating, and flatulence
1 secondary outcome
Fecal output
Time frame: subjects will collect fecal output for 12 days within a six-week 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 21 Apr 2016.
Related trials for Gastrointestinal Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Cystic Fibrosis (CF)
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.
Kevin Maki, PhD principal investigator
Provident Clinical Research Center
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 Gastrointestinal Health, run by Ingredion Incorporated 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 3 inclusion and 5 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 21 Apr 2016. 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?
Gastrointestinal tolerability (time frame: subjects will report weekly for 6 weeks). 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 21 Apr 2016.