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
|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|
|Actual 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 ]
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
|Principal Investigator:||Leila Azadbakht, PhD||Isfahan University of Medical Sciences, School of Health|