Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

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. Identifier: NCT01186276
Recruitment Status : Enrolling by invitation
First Posted : August 23, 2010
Last Update Posted : November 20, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

August 19, 2010
August 23, 2010
November 20, 2014
July 2010
December 2018   (Final data collection date for primary outcome measure)
Plasma level of p-cresol sulfate [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01186276 on Archive Site
Caloric intake [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

The study procedures will consist of:

  • taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption.
  • filling out a food record and a quality of life questionnaire
  • keeping a diary of any gi symptoms
  • collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Kidney Failure, Chronic
  • Dietary Supplement: Fiber
    Dietary fiber supplements to be consumed daily for 6 weeks.
  • Dietary Supplement: Corn starch
    Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
  • Placebo Comparator: Corn Starch
    Corn starch will serve as the control arm.
    Intervention: Dietary Supplement: Corn starch
  • Experimental: Fiber
    Fiber will serve as the intervention.
    Intervention: Dietary Supplement: Fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
December 2019
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • stable dialysis patients able to provide consent.

Exclusion Criteria:-- known g.i. disease

  • use of antibiotics for the last two month or expected antibiotic use
  • recent hospitalization or other event resulting in instability of food intake
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NIH R21AT005123-01A1
Not Provided
Not Provided
Not Provided
Stanford University
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Timothy W Meyer Stanford University
Stanford University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP