NCT03354364

Efficacy of Pea Hull Fiber in Chronic Disease

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Kidney Disease, Chronic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pea hull fiber	Snacks containing 15 g/day of ground pea hulls.
DIETARY_SUPPLEMENT	Control	Snacks without added fiber.

Timeline

• Start date: 2017-12-11
• Primary completion: 2019-06-30
• Completion: 2019-08-19
• First posted: 2017-11-27
• Last updated: 2019-09-25

Locations

2 sites across 1 country: United States