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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Dietary Supplement: Fiber Dietary Supplement: Corn starch Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
Study Start Date : July 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Starch

Arm Intervention/treatment
Placebo Comparator: Corn Starch
Corn starch will serve as the control arm.
Dietary Supplement: Corn starch
Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.

Experimental: Fiber
Fiber will serve as the intervention.
Dietary Supplement: Fiber
Dietary fiber supplements to be consumed daily for 6 weeks.

Primary Outcome Measures :
  1. Plasma level of p-cresol sulfate [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Caloric intake [ Time Frame: 8 weeks ]

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

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

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 identifier (NCT number): NCT01186276

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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Satellite Dialysis
Redwood City, California, United States, 94063
San Jose, California, United States, 95128
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
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Principal Investigator: Timothy W Meyer Stanford University

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Responsible Party: Stanford University Identifier: NCT01186276     History of Changes
Other Study ID Numbers: SU-07292010-6626
NIH R21AT005123-01A1
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

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