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NCT00067678 Clinical Trial

Soy Protein in Early Diabetic Nephropathy

Diabetes Mellitus Clinical Trial

Official title:
Soy Protein in Early Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00067678
Other study ID # R21AT000323-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 25, 2003
Last updated August 16, 2006
Start date July 2001
Est. completion date June 2003

Study information
Verified date August 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion criteria:

- Age 18-40;

- Diabetic nephropathy;

- Type I diabetes mellitus.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• soy protein

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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