Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Fiber, BUN, Serum Creatinine, Uremic Symptoms, Quality of Life
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.
Interventions
OTHERControl Food
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
OTHERFiber Fortified Food
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Sponsors
Saskatchewan Pulse Growers
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of added fiber on blood urea nitrogen (BUN) | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of foods with added fiber on Serum Creatinine | Days 1, 14, 28 and 42 of the study | Serum creatinine will be assayed using the ADVIA Chemistry CRE\_2c method. |
| Impact of foods with added fiber on bowel movement frequency | Daily | Participants will complete daily diaries to evaluate bowel movement frequency. |
| Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire | Days 1, 14, 28 and 42 | Participants will complete the Kidney Disease Quality of Life (KDQOL-36) questionnaire for 4 specific days during the study. |
| Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR) | Days 1, 14, 28 and 42 of the study | eGFR will be calculated using the Modification of Diet in Renal Disease formula on 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 Simplified Nutritional Appetite Questionnaire (SNAQ) | Days 1, 14, 28 and 42 of the study | — |
Countries
United States
Outcome results
None listed