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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Foods

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

Group Type PLACEBO_COMPARATOR

Control Food

Intervention Type OTHER

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

Fiber Fortified Foods

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

Group Type EXPERIMENTAL

Fiber Fortified Food

Intervention Type OTHER

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

Interventions

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Control Food

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

Intervention Type OTHER

Fiber Fortified Food

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

Intervention Type OTHER

Other Intervention Names

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Kellogg's Corn Pops Publix Chocolate Chip Cookies Kellogg's Special K Bar Kellogg's Corn Pops with Fiber Weight Watchers Chocolate Chip Cookies General Mills FiberOne Bar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No