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Completed

NCT Number: NCT01842087

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

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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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Food

Other

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

Fiber Fortified Food

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Impact of foods with added fiber on bowel movement frequency

    Time frame: Daily

    Participants will complete daily diaries to evaluate bowel movement frequency.

  4. 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.

  5. Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ)

    Time frame: Days 1, 14, 28 and 42 of the study

  6. Impact of foods with added fiber on Epworth Sleepiness Scale (ESS)

    Time frame: Days 1, 14, 28 and 42 of the study

  7. Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Days 1, 14, 28 and 42 of the study

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Saskatchewan Pulse Growers

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 29, 2013
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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