Efficacy of Pea Hull Fiber in Chronic Disease

Kidney Disease, Chronic Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354364
• Other study ID #: IRB201701457
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: August 19, 2019

Study information

• Verified date: September 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 19, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Pea hull fiber
Snacks containing 15 g/day of ground pea hulls.
• Control
Snacks without added fiber.

Locations

Country	Name	City	State
United States	Food Science and Human Department	Gainesville	Florida
United States	Village of Gainesville	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Saskatchewan Pulse Growers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uremic molecule - p-cresyl sulfate	Change in serum levels of microbial metabolic product, p-cresyl sulfate	baseline, 5 weeks, 9 weeks, 13 weeks
Secondary	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
Secondary	Fecal content of metabolites and minerals	Change in fecal concentration of microbial metabolites and minerals	at baseline, week 5, week 9 and week 12.
Secondary	Number of stools per week	Change in number of stools per week and mean number of stools per week per period	13 weeks
Secondary	Stool form rating	Change in stool form determined using Bristol Stool Form Scale	13 weeks
Secondary	Gastrointestinal symptom score	Change in gastrointestinal symptom score determined by GSRS (Gastrointestinal Symptom Response Scale)	at weeks 1 through 13
Secondary	Fecal microbiota profile changes	change at phylum and genus levels; changes in operational taxonomic units (OTUs)	baseline, weeks 5, 9 and 13
Secondary	Dietary intake	Change in dietary energy, macronutrient and fiber intake	baseline, weeks 5, 9 and 13
Secondary	Appetite	Change in appetite determined by SNAQ questionnaire	at weeks 1 through 13
Secondary	Quality of Life	Change in Kidney Disease Quality of Life questionnaire (KDQOL®-36)	baseline, weeks 5, 9 and 13