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Soy Protein in Early Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00067678
First received: August 25, 2003
Last updated: August 16, 2006
Last verified: August 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
Diabetes Mellitus
 Drug: soy protein
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Soy Protein in Early Diabetic Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: July 2001
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 18-40;
  • Diabetic nephropathy;
  • Type I diabetes mellitus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067678

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Paolo Fanti, MD University of Kentucky
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00067678     History of Changes
Other Study ID Numbers: R21 AT000323-01
Study First Received: August 25, 2003
Last Updated: August 16, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
diabetic nephropathy
nephropathy
diabetes
 diabetes mellitus
type I diabetes
soy protein

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on June 18, 2013