Efficacy of Pea Hull Fiber in Chronic Disease

Completed · Not applicable

Conditions studied: Kidney Disease, Chronic

In brief

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.

Key facts

Study ID

NCT03354364

Run by

University of Florida

People needed

23

Starts

2017-12-11

Expected to finish

2019-08-19

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.