Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2017-12-11
2019-08-19
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Group 1
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.
Pea hull fiber
Snacks containing 15 g/day of ground pea hulls.
Control
Snacks without added fiber.
Group 2
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
Pea hull fiber
Snacks containing 15 g/day of ground pea hulls.
Control
Snacks without added fiber.
Interventions
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Pea hull fiber
Snacks containing 15 g/day of ground pea hulls.
Control
Snacks without added fiber.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion 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
18 Years
100 Years
ALL
No
Sponsors
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Saskatchewan Pulse Growers
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Wendy J Dahl, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Village of Gainesville
Gainesville, Florida, United States
Food Science and Human Department
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201701457
Identifier Type: -
Identifier Source: org_study_id
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