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

N/ACompletedNCT01842087

University of Florida15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

Control FoodOTHER

For a period of 2 weeks, participants will consume control foods in addition to their usual diets.

Fiber Fortified FoodOTHER

For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 42 days of the study

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Days 1, 14, 28 and 42

Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)

Time frame: Days 1, 14, 28 and 42 of the study

Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)

Time frame: Days 1, 14, 28 and 42 of the study

Data from ClinicalTrials.gov

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