Kidney Disease, ChronicNCT03354364
Efficacy of Pea Hull Fiber in Chronic Disease
A study testing Pea hull fiber in people with Kidney Disease, Chronic, run by University of Florida at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effects of daily consumption of snacks with and without pea hull fiber on gastrointestinal function, gastrointestinal symptoms, food intake, appetite, changes in fecal and microbial composition and activity. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- Pea hull fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2017to 19 Aug 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years of age.
- Kidney disease stage 4 or 5 (including dialysis).
- Willing and able to complete the Consent Form in English.
- Willing to have height, weight, blood pressure, handgrip strength, and body composition measured and provide demographic information (e.g. age, race, sex).
- Willing to consume pea hull fiber snack or control snack for a 56-day period, 28 day for each type of snack.
- Willing to complete a daily, and weekly, and monthly questionnaires regarding appetite, wellness, and transit time, and quality of life throughout the entire 13-week study.
- Willing to provide three 24-hr diet recalls by phone during baseline and last week of each period.
- Willing to provide 16 days of stools and 4 blood samples throughout the study.
Who cannot join
- Do not meet the above criteria.
- Have known gastrointestinal disease (i.e., inflammatory bowel disease, malignancy, celiac disease), previous colorectal surgery.
- Allergies to ingredients in study foods provided.
- Are pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Village of Gainesville
Gainesville, Florida, 32606
Food Science and Human Department
Gainesville, Florida, 32611
About this study
Official title: Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Individuals With Lifestyle-related Chronic Disease and Overweight. (Phase 3)
The purpose of this study is to determine the effects of daily consumption of snacks with and without pea hull fiber on gastrointestinal function, gastrointestinal symptoms, food intake, appetite, changes in fecal and microbial composition and activity. Fifty maintenance hemodialysis hemodialysis and CKD patients in stage 4 or 5 will be recruited to participate in a randomized, blinded, 13-week cross-over study evaluating snack foods containing 15 g/d of pea hull fiber.
Read the detailed description
Maintenance hemodialysis hemodialysis and CKD patients in stage 4 or 5 (n=50) will be recruited for the study. A randomized, controlled, double-blind, cross-over study will be carried out. Following a 1-week baseline, participants will be assigned to receive snacks with pea hull fiber or control followed by a 4-week wash-out period, and then crossed over to the second intervention. Snacks with added pea hull fiber (15 g/d) and control will be provided to participants in identical packaging. Participants will collect 4 days of stools during the baseline week, week 5, 9, and 13 and analyzed for mineral content. Microbiota composition will be analyzed including microbial diversity, qPCR to quantify changes and 16S rRNA sequencing to identify pea hull fiber effects on specific bacteria. Following baseline, participants will attend a second visit and anthropometric and demographic information will be collected and we will measure blood pressure, the body composition by bioelectrical impedance analysis (BIA), and handgrip strength using a dynamometer.
Throughout the study, participants must complete a daily questionnaire to evaluate the transit time (eg. Bristol Stool Scale), stool frequency, and compliance. Every week, questionnaires to evaluate appetite (eg. SNAQ) and GI wellness (eg. GSRS - Gastrointestinal Symptom Response Scale) will be administered. During each study visit, participants will complete a questionnaire to evaluate the quality of life. In addition, the dietary data (24-hour diet recalls) will be collected by phone during the baseline week and during the last week of each period. During baseline, treatment and each washout, fasting blood will be collected and analyzed for a comprehensive metabolic panel with eGFR, in addition to microbial metabolites (e.g., indoxyl sulfate and p-cresyl sulfate), and inflammatory markers (e.g. CRP, TNFα, IL-6).
- Conditions
- Kidney Disease, Chronic
- Being tested
- Pea hull fiber, Control
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea hull fiberDietary supplement
Snacks containing 15 g/day of ground pea hulls.
ControlDietary supplement
Snacks without added fiber.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Receives pea hull fiber snack for the first 4 weeks and then control snack for the last 4 weeks of the study with 4-week washout between them. Receives: Dietary Supplement: Pea hull fiber; Dietary Supplement: Control |
| Group 2 | Active comparator | Receives control snack for the first 4 weeks and then pea hull fiber snack for the last 4 weeks of the study with 4-week washout between them Receives: Dietary Supplement: Pea hull fiber; Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uremic molecule - p-cresyl sulfate
Change in serum levels of microbial metabolic product, p-cresyl sulfate
Measured: baseline, 5 weeks, 9 weeks, 13 weeks
Secondary outcomes (9)
Uremic molecules (various)
Change in serum levels microbial metabolic products (e.g. indoxyl sulfate, TMAO, phenylacetyl glutamine etc.)
Measured: baseline, 5 weeks, 9 weeks, 13 weeks
Fecal content of metabolites and minerals
Change in fecal concentration of microbial metabolites and minerals
Measured: at baseline, week 5, week 9 and week 12.
Number of stools per week
Change in number of stools per week and mean number of stools per week per period
Measured: 13 weeks
Stool form rating
Change in stool form determined using Bristol Stool Form Scale
Measured: 13 weeks
Gastrointestinal symptom score
Change in gastrointestinal symptom score determined by GSRS (Gastrointestinal Symptom Response Scale)
Measured: at weeks 1 through 13
Fecal microbiota profile changes
change at phylum and genus levels; changes in operational taxonomic units (OTUs)
Measured: baseline, weeks 5, 9 and 13
Dietary intake
Change in dietary energy, macronutrient and fiber intake
Measured: baseline, weeks 5, 9 and 13
Appetite
Change in appetite determined by SNAQ questionnaire
Measured: at weeks 1 through 13
Quality of Life
Change in Kidney Disease Quality of Life questionnaire (KDQOL®-36)
Measured: baseline, weeks 5, 9 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start11 Dec 2017
- Primary completion30 Jun 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies 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
- 23 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
- NCT03354364
- Sponsor's protocol ID
- IRB201701457
- Status last verified
- Sep 2019
- First submitted
- 21 Nov 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Individuals With Lifestyle-related Chronic Disease and Overweight. (Phase 3)
- ClinicalTrials.gov ID
- NCT03354364
- Acronym / sponsor ID
- IRB201701457
- Conditions
- Kidney Disease, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Saskatchewan Pulse Growers
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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 study is to determine the effects of daily consumption of snacks with and without pea hull fiber on gastrointestinal function, gastrointestinal symptoms, food intake, appetite, changes in fecal and microbial composition and activity. Fifty maintenance hemodialysis hemodialysis and CKD patients in stage 4 or 5 will be recruited to participate in a randomized, blinded, 13-week cross-over study evaluating snack foods containing 15 g/d of pea hull fiber.
Detailed description
Maintenance hemodialysis hemodialysis and CKD patients in stage 4 or 5 (n=50) will be recruited for the study. A randomized, controlled, double-blind, cross-over study will be carried out. Following a 1-week baseline, participants will be assigned to receive snacks with pea hull fiber or control followed by a 4-week wash-out period, and then crossed over to the second intervention. Snacks with added pea hull fiber (15 g/d) and control will be provided to participants in identical packaging. Participants will collect 4 days of stools during the baseline week, week 5, 9, and 13 and analyzed for mineral content. Microbiota composition will be analyzed including microbial diversity, qPCR to quantify changes and 16S rRNA sequencing to identify pea hull fiber effects on specific bacteria. Following baseline, participants will attend a second visit and anthropometric and demographic information will be collected and we will measure blood pressure, the body composition by bioelectrical impedance analysis (BIA), and handgrip strength using a dynamometer.
Throughout the study, participants must complete a daily questionnaire to evaluate the transit time (eg. Bristol Stool Scale), stool frequency, and compliance. Every week, questionnaires to evaluate appetite (eg. SNAQ) and GI wellness (eg. GSRS - Gastrointestinal Symptom Response Scale) will be administered. During each study visit, participants will complete a questionnaire to evaluate the quality of life. In addition, the dietary data (24-hour diet recalls) will be collected by phone during the baseline week and during the last week of each period. During baseline, treatment and each washout, fasting blood will be collected and analyzed for a comprehensive metabolic panel with eGFR, in addition to microbial metabolites (e.g., indoxyl sulfate and p-cresyl sulfate), and inflammatory markers (e.g. CRP, TNFα, IL-6).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: Pea hull fiber, Dietary Supplement: ControlReceives pea hull fiber snack for the first 4 weeks and then control snack for the last 4 weeks of the study with 4-week washout between them. |
| Group 2 | Active comparator | Dietary Supplement: Pea hull fiber, Dietary Supplement: ControlReceives control snack for the first 4 weeks and then pea hull fiber snack for the last 4 weeks of the study with 4-week washout between them |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-85 years of age.
- Kidney disease stage 4 or 5 (including dialysis).
- Willing and able to complete the Consent Form in English.
- Willing to have height, weight, blood pressure, handgrip strength, and body composition measured and provide demographic information (e.g. age, race, sex).
- Willing to consume pea hull fiber snack or control snack for a 56-day period, 28 day for each type of snack.
Key exclusion criteria (4 listed)
- Do not meet the above criteria.
- Have known gastrointestinal disease (i.e., inflammatory bowel disease, malignancy, celiac disease), previous colorectal surgery.
- Allergies to ingredients in study foods provided.
- Are pregnant or lactating
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 hull fiberSnacks containing 15 g/day of ground pea hulls. | Dietary supplement | Group 1, Group 2 |
| ControlSnacks without added fiber. | Dietary supplement | Group 1, Group 2 |
Primary outcome
Uremic molecule - p-cresyl sulfate
Time frame: baseline, 5 weeks, 9 weeks, 13 weeks
Change in serum levels of microbial metabolic product, p-cresyl sulfate
9 secondary outcomes
Uremic molecules (various)
Time frame: baseline, 5 weeks, 9 weeks, 13 weeks
Fecal content of metabolites and minerals
Time frame: at baseline, week 5, week 9 and week 12.
Number of stools per week
Time frame: 13 weeks
Stool form rating
Time frame: 13 weeks
Gastrointestinal symptom score
Time frame: at weeks 1 through 13
Fecal microbiota profile changes
Time frame: baseline, weeks 5, 9 and 13
Dietary intake
Time frame: baseline, weeks 5, 9 and 13
Appetite
Time frame: at weeks 1 through 13
Quality of Life
Time frame: baseline, weeks 5, 9 and 13
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 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pea hull fiber in people with Kidney Disease, Chronic, run by University of Florida at 2 sites 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 8 inclusion and 4 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Uremic molecule - p-cresyl sulfate (time frame: baseline, 5 weeks, 9 weeks, 13 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 25 Sep 2019.