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

March 17, 2020 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control Foods
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
Other: Control Food
For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
Other Names:
  • Kellogg's Corn Pops
  • Publix Chocolate Chip Cookies
  • Kellogg's Special K Bar
EXPERIMENTAL: Fiber Fortified Foods
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Other: Fiber Fortified Food
For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
Other Names:
  • Kellogg's Corn Pops with Fiber
  • Weight Watchers Chocolate Chip Cookies
  • General Mills FiberOne Bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of added fiber on blood urea nitrogen (BUN)
Time Frame: 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.
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)
Time Frame: 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.
Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Serum Creatinine
Time Frame: Days 1, 14, 28 and 42 of the study
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
Time Frame: Daily
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
Time Frame: 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.
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
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
Days 1, 14, 28 and 42 of the study
Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Days 1, 14, 28 and 42 of the study
Days 1, 14, 28 and 42 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Saskatchewan Pulse Growers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (ESTIMATE)

April 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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