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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 1

Conditions: Kidney Transplantation

Treatments: Dietary Supplement: Soy protein

Study type: Interventional

Funder types: Other

Identifiers

NCT00555490

IsfahanUMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes with Nephrophaty

Exclusion criteria

• Dialysis
• Transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 1 patient group

1

Experimental group

Treatment:

Dietary Supplement: Soy protein