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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
23
Snacks containing 15 g/day of ground pea hulls.
Snacks without added fiber.
Village of Gainesville
Gainesville, Florida, United States
Food Science and Human Department
Gainesville, Florida, United States
Uremic molecule - p-cresyl sulfate
Change in serum levels of microbial metabolic product, p-cresyl sulfate
Time frame: baseline, 5 weeks, 9 weeks, 13 weeks
Uremic molecules (various)
Change in serum levels microbial metabolic products (e.g. indoxyl sulfate, TMAO, phenylacetyl glutamine etc.)
Time frame: baseline, 5 weeks, 9 weeks, 13 weeks
Fecal content of metabolites and minerals
Change in fecal concentration of microbial metabolites and minerals
Time frame: 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
Time frame: 13 weeks
Stool form rating
Change in stool form determined using Bristol Stool Form Scale
Time frame: 13 weeks
Gastrointestinal symptom score
Change in gastrointestinal symptom score determined by GSRS (Gastrointestinal Symptom Response Scale)
Time frame: at weeks 1 through 13
Fecal microbiota profile changes
change at phylum and genus levels; changes in operational taxonomic units (OTUs)
Time frame: baseline, weeks 5, 9 and 13
Dietary intake
Change in dietary energy, macronutrient and fiber intake
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Time frame: baseline, weeks 5, 9 and 13
Appetite
Change in appetite determined by SNAQ questionnaire
Time frame: at weeks 1 through 13
Quality of Life
Change in Kidney Disease Quality of Life questionnaire (KDQOL®-36)
Time frame: baseline, weeks 5, 9 and 13