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)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease, Chronic
• Intervention / Treatment: Dietary supplement: Pea hull fiber; Dietary supplement: Control

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • Village of Gainesville
    • Gainesville, Florida, United States, 32611
      • Food Science and Human Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Dietary supplement: Pea hull fiber; Snacks containing 15 g/day of ground pea hulls.; Dietary supplement: Control; Snacks without added fiber.
ACTIVE_COMPARATOR: 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	Dietary supplement: Pea hull fiber; Snacks containing 15 g/day of ground pea hulls.; Dietary supplement: Control; Snacks without added fiber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Saskatchewan Pulse Growers

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): August 19, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (ACTUAL): November 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Chronic Disease
• Other Study ID Numbers: IRB201701457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No