Kidney Failure, Chronic
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFiber
Dietary fiber supplements to be consumed daily for 6 weeks.
DIETARY_SUPPLEMENTCorn starch
Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
Sponsors
National Institutes of Health (NIH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma level of p-cresol sulfate | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Caloric intake | 8 weeks |
Countries
United States
Outcome results
None listed