An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Impact of added fiber on blood urea nitrogen (BUN)
Study Overview
Brief Summary
A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.
Detailed Description
Chronic Kidney Disease (CKD) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. A progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. In an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (eGFR ≤ 50 mL/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must:
- •Be 18 years of age or older
- •Have eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2 (stage 3,4 and 5 but who are not on dialysis)
Exclusion Criteria
- •Participants must not:
- •Have been diagnosed with acute kidney injury (AKI)
- •Have been diagnosed with glumerulonephritis (GN)
- •Have been on immunosuppressant/steroid medications
- •Be taking a probiotic supplement and refuse to discontinue it
- •Be scheduled for dialysis within 3 months of study initiation
- •Have a history of liver disease
- •Be on dialysis
- •Have undergone renal transplantation
- •Be breastfeeding
- •Have active gastrointestinal bleeding
- •Have a change in medications over the past 4 weeks
Arms & Interventions
Control Foods
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
Intervention: Control Food (Other)
Fiber Fortified Foods
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Intervention: Fiber Fortified Food (Other)
Outcomes
Primary Outcomes
Impact of added fiber on blood urea nitrogen (BUN)
Time Frame: up to 42 days of the study
Blood samples (10 mL) will be taken on day 1, 14, 28, and 42. BUN will be assayed using the Urea Nitrogen Concentrated Reagent method.
Secondary Outcomes
- Impact of foods with added fiber on Serum Creatinine(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)(Days 1, 14, 28 and 42 of the study)
- Impact of foods with added fiber on bowel movement frequency(Daily)
- Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire(Days 1, 14, 28 and 42)
- Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)(Days 1, 14, 28 and 42 of the study)