Status:
COMPLETED
Efficacy of Pea Hull Fiber in Chronic Disease
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Saskatchewan Pulse Growers
Conditions:
Kidney Disease, Chronic
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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, cha...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03354364
Start Date
December 11 2017
End Date
August 19 2019
Last Update
September 25 2019
Active Locations (2)
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1
Village of Gainesville
Gainesville, Florida, United States, 32606
2
Food Science and Human Department
Gainesville, Florida, United States, 32611