Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|