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Trial record 1 of 1 for:    NCT01842087
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The Effects of Fiber Fortified Foods to the Diets of Chronic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT01842087
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Control Food Other: Fiber Fortified Food Not Applicable

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 acculmulation 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: An Investigation Into Pulse Fiber Fermentation and Nitrogen Excretion in Patients With Chronic Renal Failure
Study Start Date : April 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842087


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Saskatchewan Pulse Growers
Investigators
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Principal Investigator: Wendy J Dahl, PhD, RD University of Florida

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01842087     History of Changes
Other Study ID Numbers: 16-2010
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by University of Florida:
Chronic Kidney Disease
Fiber
BUN
Serum Creatinine
Uremic Symptoms
Quality of Life

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency