Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Stanford University

Status: Completed

Conditions: Kidney Failure, Chronic

Treatments: Dietary Supplement: Fiber; Dietary Supplement: Corn starch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01186276

SU-07292010-6626

NIH R21AT005123-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups, including a placebo group

Corn Starch

Placebo Comparator group

Description:

Corn starch will serve as the control arm.

Treatment:

Dietary Supplement: Corn starch

Fiber

Experimental group

Description:

Fiber will serve as the intervention.

Treatment:

Dietary Supplement: Fiber