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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Food
Fiber Fortified Food
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Fiber, BUN, Serum Creatinine, Uremic Symptoms, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Foods

Fiber Fortified Foods

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Impact of foods with added fiber on Serum Creatinine
Serum creatinine will be assayed using the ADVIA Chemistry CRE_2c method.
Impact of foods with added fiber on bowel movement frequency
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
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)
Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)
Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)

Full Information

First Posted
April 18, 2013
Last Updated
March 17, 2020
Sponsor
University of Florida
Collaborators
Saskatchewan Pulse Growers
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1. Study Identification

Unique Protocol Identification Number
NCT01842087
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Saskatchewan Pulse Growers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Fiber, BUN, Serum Creatinine, Uremic Symptoms, Quality of Life

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Foods
Arm Type
Placebo Comparator
Arm Description
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
Arm Title
Fiber Fortified Foods
Arm Type
Experimental
Arm Description
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Intervention Type
Other
Intervention Name(s)
Control Food
Other Intervention Name(s)
Kellogg's Corn Pops, Publix Chocolate Chip Cookies, Kellogg's Special K Bar
Intervention Description
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
Intervention Type
Other
Intervention Name(s)
Fiber Fortified Food
Other Intervention Name(s)
Kellogg's Corn Pops with Fiber, Weight Watchers Chocolate Chip Cookies, General Mills FiberOne Bar
Intervention Description
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Primary Outcome Measure Information:
Title
Impact of added fiber on blood urea nitrogen (BUN)
Description
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 Outcome Measure Information:
Title
Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)
Description
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
Title
Impact of foods with added fiber on Serum Creatinine
Description
Serum creatinine will be assayed using the ADVIA Chemistry CRE_2c method.
Time Frame
Days 1, 14, 28 and 42 of the study
Title
Impact of foods with added fiber on bowel movement frequency
Description
Participants will complete daily diaries to evaluate bowel movement frequency.
Time Frame
Daily
Title
Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire
Description
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
Title
Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)
Time Frame
Days 1, 14, 28 and 42 of the study
Title
Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)
Time Frame
Days 1, 14, 28 and 42 of the study
Title
Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame
Days 1, 14, 28 and 42 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy J Dahl, PhD, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24304924
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.
Results Reference
derived

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

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