Clinical trial NCT01842087: The Effects of Fiber Fortified Foods to the Diets of Chronic Kidney Disease Patients
Official title: An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Fiber
BUN
Serum Creatinine
Uremic Symptoms
Quality of Life
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Saskatchewan Pulse Growers
First posted: 2013-04-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of added fiber on blood urea nitrogen (BUN)
timeFrame: up to 42 days of the study
Secondary outcomes:
measure: Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)
timeFrame: Days 1, 14, 28 and 42 of the study
measure: Impact of foods with added fiber on Serum Creatinine
timeFrame: Days 1, 14, 28 and 42 of the study
measure: Impact of foods with added fiber on bowel movement frequency
timeFrame: Daily
measure: Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire
timeFrame: Days 1, 14, 28 and 42
measure: Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)
timeFrame: Days 1, 14, 28 and 42 of the study
measure: Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)
timeFrame: Days 1, 14, 28 and 42 of the study
measure: Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Days 1, 14, 28 and 42 of the study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmean YA, Zello GA, Dahl WJ. Foods with added fiber improve stool frequency in individuals with chronic kidney disease with no impact on appetite or overall quality of life. BMC Res Notes. 2013 Dec 5;6:510. doi: 10.1186/1756-0500-6-510.