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

This study has been completed.
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00555490
First received: November 7, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 7, 2007
November 7, 2007
April 2001
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mortality or using dialysis [ Time Frame: 4-years ]
Same as current
No Changes Posted
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Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Kidney Transplantation
Dietary Supplement: Soy protein
35 % of protein from soy protein for 4-years
Experimental: 1
Intervention: Dietary Supplement: Soy protein
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
September 2005
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Inclusion Criteria:

  • Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

  • Dialysis
  • Transplantation
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00555490
IsfahanUMS
Not Provided
Not Provided
Isfahan University of Medical Sciences
Shahid Beheshti Medical University
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences, School of Health
Isfahan University of Medical Sciences
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP