The Effects of Fiber Fortified Foods to the Diets of Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Control Food
* Other: Fiber Fortified Food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Foods<br>For a period of 2 weeks, participants will consume control foods in addition to their usual diets. | Other: Control Food<br>* For a period of 2 weeks, participants will consume control foods in addition to their usual diets.<br>* Other names: Kellogg's Special K Bar;|
| Experimental: Fiber Fortified Foods<br>For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets. | Other: Fiber Fortified Food<br>* For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.<br>* Other names: General Mills FiberOne Bar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of added fiber on blood urea nitrogen (BUN) | 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. | up to 42 days of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR) | eGFR will be calculated using the Modification of Diet in Renal Disease formula on days 1, 14, 28 and 42 of the study. | Days 1, 14, 28 and 42 of the study | 
| Impact of foods with added fiber on Serum Creatinine | Serum creatinine will be assayed using the ADVIA Chemistry CRE_2c method. | Days 1, 14, 28 and 42 of the study | 
| Impact of foods with added fiber on bowel movement frequency | Participants will complete daily diaries to evaluate bowel movement frequency. | Daily | 
| Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire | Participants will complete the Kidney Disease Quality of Life (KDQOL-36) questionnaire for 4 specific days during the study. | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Fiber, BUN, Serum Creatinine, Uremic Symptoms, Quality of Life