Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01842087
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01842087
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
University of Florida

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Saskatchewan Pulse Growers
Investigators
Layout table for investigator information
Principal Investigator: Wendy J Dahl, PhD, RD University of Florida
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01842087    
Other Study ID Numbers: 16-2010
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Keywords provided by University of Florida:
Chronic Kidney Disease
Fiber
BUN
 Serum Creatinine
Uremic Symptoms
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
 Renal Insufficiency
Iproplatin
Antineoplastic Agents