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

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ClinicalTrials.gov Identifier: NCT00555490
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : November 8, 2007
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Dietary Supplement: Soy protein Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Soy-Protein Intake, Cardio-Renal Indices and C-Reactive Protein in Type 2 Diabetes With Nephropathy: a 4-y Randomized Clincal Trial
Study Start Date : April 2001
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Dietary Supplement: Soy protein
35 % of protein from soy protein for 4-years

Outcome Measures

Primary Outcome Measures :
  1. mortality or using dialysis [ Time Frame: 4-years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

  • Dialysis
  • Transplantation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555490

Sponsors and Collaborators
Isfahan University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences, School of Health
More Information

ClinicalTrials.gov Identifier: NCT00555490     History of Changes
Other Study ID Numbers: IsfahanUMS
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: November 8, 2007
Last Verified: November 2007

Keywords provided by Isfahan University of Medical Sciences:

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases