HealthyNCT02778230
Efficacy of Pea Hull Fibre Supplementation
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 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pea Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 27 Dec 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
- Willing to consume pea hull fiber and control snacks daily each for a 2-week period
- Willing to complete a daily questionnaire regarding general and gastrointestinal wellness throughout the entire 10-weeks study.
- Willing to complete the GSRS (Gastrointestinal Symptom Rating Scale) and SNAQ questionnaires bi-weekly at study appointments.
- Willing to be interviewed for a 24-hr food recall, 3 times per 2-weeks period throughout the study.
- Willing to provide 5 stool samples, one in each 2-weeks period throughout the study.
- 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.
- 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 diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and Human Department
Gainesville, Florida, 32611
About this study
Official title: Efficacy of Pea Hull Fibre Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Older Adults.
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
A 10-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, gastrointestinal symptoms, stool frequency, and stool consistency (transit time) will be collected by paper questionnaire, and participants will collect a single stool. Dietary data (24-hour dietary recalls) will be obtained via phone interviews 3 times during the baseline period. On or about day 15, participants will attend a study visit and complete the Simplified Nutritional Appetite Questionnaire (SNAQ) and Gastrointestinal Symptom Response Scale (GSRS). 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 appetite, gastrointestinal symptoms, and stool frequency and consistency (transit time). Furthermore, they will complete SNAQ and GSRS after the end of each intervention period. The 24-hour dietary recalls will also be collected 3 times during each of the intervention periods. Participants will undergo an additional 2-week washout period after the second intervention period. During washout periods, the same data will be collected as was done during the baseline and intervention periods.Participants will be asked to collect one stool during pre-baseline and weeks 4, 6, 8 and 10 for a total of 5 stools. Stool samples will be analyzed for changes in the microbiota.
- Conditions
- Healthy
- Being tested
- Pea Fiber, Control
- Keywords
- fiber, gastrointestinal, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea FiberDietary supplement
Snacks (2 baked goods) fortified with 5 g pea hull fiber
ControlDietary supplement
Snacks (2 baked goods) without fiber fortification.
| Study group | Role | What they receive |
|---|---|---|
| Pea Fiber | Experimental | Two fiber snacks fortified with 5 g/each of pea fiber (Best Pea Fiber 200) will be consumed each day for a period of two weeks. Receives: Dietary Supplement: Pea Fiber |
| Control | Other | Two control snacks will be consumed each day for a period of two weeks. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency rating by Bristol Stool Form Scale
Assesses estimated transit time.
Measured: Changes from baseline to week 4, 6, 8 and 10.
Secondary outcomes (4)
Number of bowel movements per day averaged by week
stool frequency
Measured: Changes from baseline to week 4, 6, 8, and 10
Microbiota profile changes: percent change at phylum and genus levels; changes in OTUs
Measured: Changes from baseline to week 4, 6, 8, and 10
GSRS (Gastrointestinal Symptom Response Scale) score.
Measured: Changes from baseline to week 4, 6, 8, and 10
SNAQ (Simplified Nutritional Appetite Questionnaire) score.
Measured: Changes from baseline to week 4, 6, 8, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017
- Study completion27 Dec 2018
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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 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
- NCT02778230
- Sponsor's protocol ID
- IRB201600646
- Status last verified
- Apr 2019
- First submitted
- 12 May 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No current plan.
Publications
Alyousif Z, Mendoza DR, Auger J, De Carvalho V, Amos S, Sims C, Dahl WJ. Gastrointestinal Tolerance and Microbiome Response to Snacks Fortified with Pea Hull Fiber: A Randomized Trial in Older Adults. Curr Dev Nutr. 2020 Jan 17;4(2):nzaa005. doi: 10.1093/cdn/nzaa005. eCollection 2020 Feb.
PubMed 32025615
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pea Hull Fibre Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Older Adults.
- ClinicalTrials.gov ID
- NCT02778230
- Acronym / sponsor ID
- IRB201600646
- Conditions
- Healthy
- Keywords
- fiber, gastrointestinal, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 19 May 2016 (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
A 10-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, gastrointestinal symptoms, stool frequency, and stool consistency (transit time) will be collected by paper questionnaire, and participants will collect a single stool. Dietary data (24-hour dietary recalls) will be obtained via phone interviews 3 times during the baseline period. On or about day 15, participants will attend a study visit and complete the Simplified Nutritional Appetite Questionnaire (SNAQ) and Gastrointestinal Symptom Response Scale (GSRS). 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 appetite, gastrointestinal symptoms, and stool frequency and consistency (transit time). Furthermore, they will complete SNAQ and GSRS after the end of each intervention period. The 24-hour dietary recalls will also be collected 3 times during each of the intervention periods. Participants will undergo an additional 2-week washout period after the second intervention period. During washout periods, the same data will be collected as was done during the baseline and intervention periods.Participants will be asked to collect one stool during pre-baseline and weeks 4, 6, 8 and 10 for a total of 5 stools. Stool samples will be analyzed for changes in the microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pea Fiber | Experimental | Dietary Supplement: Pea FiberTwo fiber snacks fortified with 5 g/each of pea fiber (Best Pea Fiber 200) will be consumed each day for a period of two weeks. |
| Control | Other | Dietary Supplement: ControlTwo control snacks will be consumed each day for a period of two weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
- Willing to consume pea hull fiber and control snacks daily each for a 2-week period
- Willing to complete a daily questionnaire regarding general and gastrointestinal wellness throughout the entire 10-weeks study.
- Willing to complete the GSRS (Gastrointestinal Symptom Rating Scale) and SNAQ questionnaires bi-weekly at study appointments.
- Willing to be interviewed for a 24-hr food recall, 3 times per 2-weeks period throughout the study.
Key exclusion criteria (5 listed)
- Have any known food allergies.
- Are currently taking medications for diarrhea.
- Have taken antibiotics within the past four weeks prior to randomization.
- 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 diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
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 FiberSnacks (2 baked goods) fortified with 5 g pea hull fiber | Dietary supplement | Pea Fiber |
| ControlSnacks (2 baked goods) without fiber fortification. | Dietary supplement | Control |
Primary outcome
Stool consistency rating by Bristol Stool Form Scale
Time frame: Changes from baseline to week 4, 6, 8 and 10.
Assesses estimated transit time.
4 secondary outcomes
Number of bowel movements per day averaged by week
Time frame: Changes from baseline to week 4, 6, 8, and 10
Microbiota profile changes: percent change at phylum and genus levels; changes in OTUs
Time frame: Changes from baseline to week 4, 6, 8, and 10
GSRS (Gastrointestinal Symptom Response Scale) score.
Time frame: Changes from baseline to week 4, 6, 8, and 10
SNAQ (Simplified Nutritional Appetite Questionnaire) score.
Time frame: Changes from baseline to week 4, 6, 8, and 10
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 5 Apr 2019.
- Derived from this study: PubMed 32025615Alyousif Z, Mendoza DR, Auger J, De Carvalho V, Amos S, Sims C, Dahl WJ. Gastrointestinal Tolerance and Microbiome Response to Snacks Fortified with Pea Hull Fiber: A Randomized Trial in Older Adults. Curr Dev Nutr. 2020 Jan 17;4(2):nzaa005. doi: 10.1093/cdn/nzaa005. eCollection 2020 Feb.
- Individual participant dataSharing planned: Undecided. No current plan.
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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 7 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 5 Apr 2019. 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 consistency rating by Bristol Stool Form Scale (time frame: Changes from baseline to week 4, 6, 8 and 10.). 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 NCT02778230, 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 5 Apr 2019.