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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842087
• Other study ID #: 16-2010
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Saskatchewan Pulse Growers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 42 days of the study
Secondary	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.	Days 1, 14, 28 and 42 of the study
Secondary	Impact of foods with added fiber on Serum Creatinine	Serum creatinine will be assayed using the ADVIA Chemistry CRE_2c method.	Days 1, 14, 28 and 42 of the study
Secondary	Impact of foods with added fiber on bowel movement frequency	Participants will complete daily diaries to evaluate bowel movement frequency.	Daily
Secondary	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.	Days 1, 14, 28 and 42
Secondary	Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)		Days 1, 14, 28 and 42 of the study
Secondary	Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)		Days 1, 14, 28 and 42 of the study
Secondary	Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)		Days 1, 14, 28 and 42 of the study