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OpenTrials
Completed

NCT Number: NCT01186276

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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiber

Dietary Supplement

Dietary fiber supplements to be consumed daily for 6 weeks.

Corn Starch

Dietary Supplement

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

Primary outcomes

  1. Plasma level of p-cresol sulfate

    Time frame: 8 weeks

Secondary outcomes

  1. Caloric intake

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2010
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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