HealthyNCT03016065
Efficacy of Pea Hull Fiber - Phase 2
A study testing Pea Fiber in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pea Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 15 Nov 2022
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
- Children age between 8-15 years old.
- Are occasionally constipated.
- Are willing to consume pea hull fiber and control snacks daily each for a 2-week period
- Are willing to complete a daily questionnaire throughout the entire 8-week study.
- Are willing to complete the appetite questionnaire two times per week.
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- Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) bi-weekly.
- Are willing to be interviewed for Automated Self-Administered 24-Hour-Kids-2014 (ASA24-Kids-2014) one time per 2-week period throughout the study.
- Are willing and be able to provide a valid social security for study payment purposes.
Who cannot join
- Have any known food allergies.
- Are currently taking medications for diarrhea.
- Have taken antibiotics within the past four weeks prior to randomization.
- Have ≥ 6 bowel movements per week
- Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study.
- Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Food Science and Human Nutrition Dept
Gainesville, Florida, 32611
About this study
Official title: Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit in Overweight Children.
The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity.
Read the detailed description
An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull fiber. Participants will complete a 2-week baseline period during which appetite, stool frequency, and stool consistency (transit time) will be collected by an online questionnaire, and participants will collect a single stool. Dietary data (Automated Self-Administered 24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week treatment period separated by a 2-week washout period. In both intervention periods, participants will complete daily questionnaires to assess stool frequency and consistency (transit time). An online questionnaire assessing appetite will be administered once per week. The GSRS will be competed at each study visit. During washout periods, the same data will be collected as will be done during the baseline and intervention periods. Participants will be asked to collect one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples will be analyzed for changes in the microbiota.
- Conditions
- Healthy
- Being tested
- Pea Fiber, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea FiberDietary supplement
Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
ControlDietary supplement
Baked goods (2 snacks) without added fiber
| Study group | Role | What they receive |
|---|---|---|
| Pea Fiber | Experimental | Snacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks. Receives: Dietary Supplement: Pea Fiber |
| Control | Placebo comparator | Control snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Bristol Stool Form score
Stool consistency rating by Modified Bristol Stool Form for children
Measured: Change from baseline at weeks 4, 6 and 8
Secondary outcomes (1)
Change in number of bowel movements per week
Stool frequency per week
Measured: Change from baseline at weeks 4, 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start29 Mar 2017
- Primary completion15 Dec 2019
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Pulse Growers
- Responsible party
- Sponsor
- Investigators
- Wendy J Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016065
- Sponsor's protocol ID
- IRB201602266
- Status last verified
- Nov 2022
- First submitted
- 6 Jan 2017
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit in Overweight Children.
- ClinicalTrials.gov ID
- NCT03016065
- Acronym / sponsor ID
- IRB201602266
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 10 Jan 2017 (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 this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity.
Detailed description
An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull fiber. Participants will complete a 2-week baseline period during which appetite, stool frequency, and stool consistency (transit time) will be collected by an online questionnaire, and participants will collect a single stool. Dietary data (Automated Self-Administered 24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week treatment period separated by a 2-week washout period. In both intervention periods, participants will complete daily questionnaires to assess stool frequency and consistency (transit time). An online questionnaire assessing appetite will be administered once per week. The GSRS will be competed at each study visit. During washout periods, the same data will be collected as will be done during the baseline and intervention periods. Participants will be asked to collect one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples will be analyzed for changes in the microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pea Fiber | Experimental | Dietary Supplement: Pea FiberSnacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks. |
| Control | Placebo comparator | Dietary Supplement: ControlControl snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
- Children age between 8-15 years old.
- Are occasionally constipated.
- Are willing to consume pea hull fiber and control snacks daily each for a 2-week period
- Are willing to complete a daily questionnaire throughout the entire 8-week study.
Key exclusion criteria (6 listed)
- Have any known food allergies.
- Are currently taking medications for diarrhea.
- Have taken antibiotics within the past four weeks prior to randomization.
- Have ≥ 6 bowel movements per week
- Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study.
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 |
|---|---|---|
| Pea FiberBaked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls | Dietary supplement | Pea Fiber |
| ControlBaked goods (2 snacks) without added fiber | Dietary supplement | Control |
Primary outcome
Change in Modified Bristol Stool Form score
Time frame: Change from baseline at weeks 4, 6 and 8
Stool consistency rating by Modified Bristol Stool Form for children
1 secondary outcome
Change in number of bowel movements per week
Time frame: Change from baseline at weeks 4, 6 and 8
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 29 Nov 2022.
- Individual participant dataSharing planned: No
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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 Pea Fiber in people with Healthy, 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 9 inclusion and 6 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 29 Nov 2022. 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?
Change in Modified Bristol Stool Form score (time frame: Change from baseline at weeks 4, 6 and 8). 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 29 Nov 2022.