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| Name | Class |
|---|---|
| Saskatchewan Pulse Growers | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pea hull fiber | Dietary Supplement | Snacks containing 15 g/day of ground pea hulls. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uremic molecule - p-cresyl sulfate | Change in serum levels of microbial metabolic product, p-cresyl sulfate | baseline, 5 weeks, 9 weeks, 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Uremic molecules (various) | Change in serum levels microbial metabolic products (e.g. indoxyl sulfate, TMAO, phenylacetyl glutamine etc.) | baseline, 5 weeks, 9 weeks, 13 weeks |
| Fecal content of metabolites and minerals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy J Dahl, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Village of Gainesville | Gainesville | Florida | 32606 | United States | ||
| Food Science and Human Department |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Control | Dietary Supplement | Snacks without added fiber. |
|
Change in fecal concentration of microbial metabolites and minerals
| 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 | 13 weeks |
| Stool form rating | Change in stool form determined using Bristol Stool Form Scale | 13 weeks |
| Gastrointestinal symptom score | Change in gastrointestinal symptom score determined by GSRS (Gastrointestinal Symptom Response Scale) | at weeks 1 through 13 |
| Fecal microbiota profile changes | change at phylum and genus levels; changes in operational taxonomic units (OTUs) | baseline, weeks 5, 9 and 13 |
| Dietary intake | Change in dietary energy, macronutrient and fiber intake | baseline, weeks 5, 9 and 13 |
| Appetite | Change in appetite determined by SNAQ questionnaire | at weeks 1 through 13 |
| Quality of Life | Change in Kidney Disease Quality of Life questionnaire (KDQOL®-36) | baseline, weeks 5, 9 and 13 |
| Gainesville |
| Florida |
| 32611 |
| United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |