Gastrointestinal SymptomsNCT01964599
Potato Fiber and Gastrointestinal Function: Phase 3
A study testing PF-RS, PF-RO1 and PF-RO2 in people with Gastrointestinal Symptoms and Gastrointestinal Transit Time, run by University of Florida at 1 site in United States.
Trial summary
The primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms, Gastrointestinal Transit Time, Stool Frequency
- What is being tested?
- PF-RS, PF-RO1 and PF-RO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2014
- 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
- must be between the ages of 18 and 65.
- must be willing to complete daily questionnaires.
- must be willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
- must have internet access for the duration of the study
- must have usual fiber intake of <20 g/d based on Food Frequency Questionnaire such as the Block Fruit/Vegetable/Fiber Screener
- must be willing to consume kool-aid everyday for 2 periods of 14 days
- must be willing to provide stool samples
Who cannot join
- must not have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
- must not have a food allergy
- must not take dietary supplements (prebiotic and fiber supplements)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Food Science & Human Nutrition Dept
Gainesville, Florida, 32601
About this study
Official title: Potato Fiber and Gastrointestinal Function: Phase 3 (Grant #94521)
The primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Fermentation of resistant starches by microbiota increases bacterial numbers, which increases fecal bulk and may impact frequency and transit time. The purpose of this study is to determine the effects of resistant potato starches (potato fiber) on stool frequency, transit time and microbiota in healthy individuals.
Read the detailed description
Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant changes in gastrointestinal function and microbiota profile.
Objectives:
- To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.
- To determine the effect of potato fibers on microbial diversity in healthy individuals.
- Being tested
- PF-RS, PF-RO1, PF-RO2, Control
- Keywords
- Fiber, Gastrointestinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-RSDietary supplement
n=20 will consume PF-RS containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.
PF-RO1Dietary supplement
n=20 will consume PF-RO1 containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.
PF-RO2Dietary supplement
n=20 will consume PF-RO2 containing 30 g potato fiber for 14 days and then will consume a control containing no fiber for 14 days.
ControlDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| PF-RS | Other | 14 days consuming the PF-RS containing 30 g fiber and then 14 days consuming the control containing no fiber Receives: Dietary Supplement: PF-RS; Dietary Supplement: Control |
| PF-RO1 | Other | 14 days consuming the PF-RO1 containing 30 g fiber and then 14 days consuming the control containing no fiber Receives: Dietary Supplement: PF-RO1; Dietary Supplement: Control |
| PF-RO2 | Other | 14 days consuming the PF-RO2 containing 30 g fiber and then 14 days consuming the control containing no fiber Receives: Dietary Supplement: PF-RO2; Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Frequency
Change in stool frequency determined by the daily questionnaire
Measured: 6 weeks
Secondary outcomes (3)
Gastrointestinal transit time
Change in gastrointestinal transit time determined by the Bristol Stool Scale
Measured: 6 weeks
Gastrointestinal symptoms
Change in gastrointestinal symptoms determined by the daily questionnaire
Measured: 6 weeks
Microbial diversity
Baseline, treatment, control and washout stools (for a total of 6 samples) for each subject will be sampled for DNA isolation for microbiota studies. Microbial diversity measured by DGGE profiling (detects large distortions), qPCR to quantify changes and 16S rRNA sequencing (454) to identify treatment effects on specific bacteria (discovery) will be undertaken.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy J Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964599
- Sponsor's protocol ID
- 215-2011
- Status last verified
- Jan 2017
- First submitted
- 14 Oct 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potato Fiber and Gastrointestinal Function: Phase 3 (Grant #94521)
- ClinicalTrials.gov ID
- NCT01964599
- Acronym / sponsor ID
- 215-2011
- Keywords
- Fiber, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Oct 2013 (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 primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Fermentation of resistant starches by microbiota increases bacterial numbers, which increases fecal bulk and may impact frequency and transit time. The purpose of this study is to determine the effects of resistant potato starches (potato fiber) on stool frequency, transit time and microbiota in healthy individuals.
Detailed description
Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant changes in gastrointestinal function and microbiota profile.
Objectives:
- To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.
- To determine the effect of potato fibers on microbial diversity in healthy individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-RS | Other | Dietary Supplement: PF-RS, Dietary Supplement: Control14 days consuming the PF-RS containing 30 g fiber and then 14 days consuming the control containing no fiber |
| PF-RO1 | Other | Dietary Supplement: PF-RO1, Dietary Supplement: Control14 days consuming the PF-RO1 containing 30 g fiber and then 14 days consuming the control containing no fiber |
| PF-RO2 | Other | Dietary Supplement: PF-RO2, Dietary Supplement: Control14 days consuming the PF-RO2 containing 30 g fiber and then 14 days consuming the control containing no fiber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- must be between the ages of 18 and 65.
- must be willing to complete daily questionnaires.
- must be willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
- must have internet access for the duration of the study
- must have usual fiber intake of <20 g/d based on Food Frequency Questionnaire such as the Block Fruit/Vegetable/Fiber Screener
Key exclusion criteria (3 listed)
- must not have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
- must not have a food allergy
- must not take dietary supplements (prebiotic and fiber supplements)
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 |
|---|---|---|
| PF-RSn=20 will consume PF-RS containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days. | Dietary supplement | PF-RS |
| PF-RO1n=20 will consume PF-RO1 containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days. | Dietary supplement | PF-RO1 |
| PF-RO2n=20 will consume PF-RO2 containing 30 g potato fiber for 14 days and then will consume a control containing no fiber for 14 days. | Dietary supplement | PF-RO2 |
| Control | Dietary supplement | PF-RO1, PF-RO2, PF-RS |
Primary outcome
Stool Frequency
Time frame: 6 weeks
Change in stool frequency determined by the daily questionnaire
3 secondary outcomes
Gastrointestinal transit time
Time frame: 6 weeks
Gastrointestinal symptoms
Time frame: 6 weeks
Microbial diversity
Time frame: 6 weeks
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 26 Jan 2017.
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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.
Wendy J Dahl, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PF-RS, PF-RO1 and PF-RO2 in people with Gastrointestinal Symptoms and Gastrointestinal Transit Time, run by University of Florida 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 3 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 26 Jan 2017. 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 Frequency (time frame: 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 26 Jan 2017.