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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Fiber Fortified Food; Other: Control Food

• Registration Number: NCT01842087
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fiber Fortified Foods	Fiber Fortified Food	For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Control Foods	Control Food	For a period of 2 weeks, participants will consume control foods in addition to their usual diets.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 Simplified Nutritional Appetite Questionnaire (SNAQ)	Days 1, 14, 28 and 42 of the study

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States