Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy
|ClinicalTrials.gov Identifier: NCT00555490|
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : November 8, 2007
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Dietary Supplement: Soy protein||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Dietary Supplement: Soy protein
35 % of protein from soy protein for 4-years
- mortality or using dialysis [ Time Frame: 4-years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555490
|Principal Investigator:||Leila Azadbakht, PhD||Isfahan University of Medical Sciences, School of Health|