Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy

November 7, 2007 updated by: Isfahan University of Medical Sciences

Soy-Protein Intake, Cardio-Renal Indices and C-Reactive Protein in Type 2 Diabetes With Nephropathy: a 4-y Randomized Clincal Trial

we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic patients with nephropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy.

Objectives: To determine the effects of long-term soy consumption on cardiovascular risks, C-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy.

Design: This longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). Twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

  • Dialysis
  • Transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Dietary supplement: Soy protein
35 % of protein from soy protein for 4-years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality or using dialysis
Time Frame: 4-years
4-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Leila Azadbakht, PhD, Isfahan University of Medical Sciences, School of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (ESTIMATE)

November 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2007

Last Update Submitted That Met QC Criteria

November 7, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IsfahanUMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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