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Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Primary Purpose

Kidney Failure, Chronic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fiber

Corn starch

About this trial

This is an interventional other trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Palo Alto Health Care System
Satellite Dialysis
SCVMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Corn Starch

Fiber

Arm Description

Corn starch will serve as the control arm.

Fiber will serve as the intervention.

Outcomes

Primary Outcome Measures

Plasma level of p-cresol sulfate

Secondary Outcome Measures

Caloric intake

Full Information

NCT ID

NCT01186276

First Posted

August 19, 2010

Last Updated

August 22, 2022

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01186276

Brief Title

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Official Title

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

July 2010 (Actual)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Corn Starch

Arm Type

Placebo Comparator

Arm Description

Corn starch will serve as the control arm.

Arm Title

Fiber

Arm Type

Experimental

Arm Description

Fiber will serve as the intervention.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fiber

Intervention Description

Dietary fiber supplements to be consumed daily for 6 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Corn starch

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma level of p-cresol sulfate

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Caloric intake

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy W Meyer

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Satellite Dialysis

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Facility Name

SCVMC

City

San Jose

State/Province

California

ZIP/Postal Code

95128

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

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