Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Corn Starch

Corn starch will serve as the control arm.

Group Type PLACEBO_COMPARATOR

Corn starch

Intervention Type DIETARY_SUPPLEMENT

Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.

Fiber

Fiber will serve as the intervention.

Group Type EXPERIMENTAL

Fiber

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber supplements to be consumed daily for 6 weeks.

Interventions

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Fiber

Dietary fiber supplements to be consumed daily for 6 weeks.

Intervention Type DIETARY_SUPPLEMENT

Corn starch

Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* stable dialysis patients able to provide consent.

Exclusion Criteria

* use of antibiotics for the last two month or expected antibiotic use
* recent hospitalization or other event resulting in instability of food intake

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No