Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Dietary Supplement: Corn starch; Dietary Supplement: Fiber

• Registration Number: NCT01186276
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• stable dialysis patients able to provide consent.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corn Starch	Corn starch	Corn starch will serve as the control arm.
Fiber	Fiber	Fiber will serve as the intervention.

Primary Outcome Measures

Name	Time	Method
Plasma level of p-cresol sulfate	8 weeks

Secondary Outcome Measures

Name	Time	Method
Caloric intake	8 weeks

Trial Locations

Locations (3)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Satellite Dialysis; 🇺🇸 Redwood City, California, United States

SCVMC; 🇺🇸 San Jose, California, United States