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Soy Protein in Early Diabetic Nephropathy

NCT ID: NCT00067678

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Nephropathy Diabetes Mellitus

Keywords

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diabetic nephropathy nephropathy diabetes diabetes mellitus type I diabetes soy protein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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soy protein

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-40;
* Diabetic nephropathy;
* Type I diabetes mellitus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Paolo Fanti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT000323-01

Identifier Type: NIH

Identifier Source: org_study_id

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