Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Dietary supplement: Corn starch; Dietary supplement: Fiber

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System
    • Redwood City, California, United States, 94063
      • Satellite Dialysis
    • San Jose, California, United States, 95128
      • SCVMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma level of p-cresol sulfate	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Caloric intake	8 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Timothy W Meyer, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2010
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (ESTIMATE): August 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: SU-07292010-6626; NIH R21AT005123-01A1