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Soy Protein in Early Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067678
First Posted: August 27, 2003
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
August 25, 2003
August 27, 2003
August 18, 2006
July 2001
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Complete list of historical versions of study NCT00067678 on ClinicalTrials.gov Archive Site
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Soy Protein in Early Diabetic Nephropathy
Soy Protein in Early Diabetic Nephropathy
Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary protein has been used to slow down renal disease progression, but patients are often unwilling to make these dietary changes. Other research suggests that changing the quality of dietary protein may be as effective as reducing the total amount of ingested protein. This study hopes to show that soy protein, a plant protein relatively high in essential amino acids and with high nutritional value, maye be beneficial to Type I diabetic patients with incipient renal disease.
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Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Diabetic Nephropathy
  • Diabetes Mellitus
Drug: soy protein
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2003
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Inclusion criteria:

  • Age 18-40;
  • Diabetic nephropathy;
  • Type I diabetes mellitus.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00067678
R21AT000323-01( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Paolo Fanti, MD University of Kentucky
National Center for Complementary and Integrative Health (NCCIH)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP