NCT01842087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

April 18, 2013

Last Update Submit

March 17, 2020

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseaseFiberBUNSerum CreatinineUremic SymptomsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR)

    Days 1, 14, 28 and 42 of the study

  • Impact of foods with added fiber on Serum Creatinine

    Days 1, 14, 28 and 42 of the study

  • Impact of foods with added fiber on bowel movement frequency

    Daily

  • Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire

    Days 1, 14, 28 and 42

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

    Days 1, 14, 28 and 42 of the study

  • +2 more secondary outcomes

Study Arms (2)

Control Foods

PLACEBO COMPARATOR

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

Other: Control Food

Fiber Fortified Foods

EXPERIMENTAL

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

Other: Fiber Fortified Food

Interventions

Control FoodOTHER

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

Also known as: Kellogg's Corn Pops, Publix Chocolate Chip Cookies, Kellogg's Special K Bar
Control Foods
Fiber Fortified FoodOTHER

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

Also known as: Kellogg's Corn Pops with Fiber, Weight Watchers Chocolate Chip Cookies, General Mills FiberOne Bar
Fiber Fortified Foods

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Salmean YA, Zello GA, Dahl WJ. Foods with added fiber improve stool frequency in individuals with chronic kidney disease with no impact on appetite or overall quality of life. BMC Res Notes. 2013 Dec 5;6:510. doi: 10.1186/1756-0500-6-510.

    PMID: 24304924DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Hazard Analysis and Critical Control PointsDietary Fiber

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food SafetyFood QualityFood TechnologyFood IndustryIndustryTechnology, Industry, and AgricultureSafetyAccident PreventionAccidentsPublic HealthEnvironment and Public HealthDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Wendy J Dahl, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 29, 2013

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

US(1)