Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
|ClinicalTrials.gov Identifier: NCT01186276|
Recruitment Status : Enrolling by invitation
First Posted : August 23, 2010
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure, Chronic||Dietary Supplement: Fiber Dietary Supplement: Corn starch||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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.
Fiber will serve as the intervention.
Dietary Supplement: Fiber
Dietary fiber supplements to be consumed daily for 6 weeks.
- Plasma level of p-cresol sulfate [ Time Frame: 8 weeks ]
- Caloric intake [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186276
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304|
|Redwood City, California, United States, 94063|
|San Jose, California, United States, 95128|
|Principal Investigator:||Timothy W Meyer||Stanford University|