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

University of Florida

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Fiber Fortified Food; Other: Control Food

Study type: Interventional

Funder types: Other

Identifiers

NCT01842087

16-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

Control Foods

Placebo Comparator group

Description:

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

Treatment:

Other: Control Food

Fiber Fortified Foods

Experimental group

Description:

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

Treatment:

Other: Fiber Fortified Food