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

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.

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Key information

Conditions

Kidney Transplantation Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 Diabetes with Nephrophaty

Exclusion criteria

Dialysis
Transplantation

Treatment and study plan

Soy protein

Dietary Supplement

35 % of protein from soy protein for 4-years

Primary outcomes

mortality or using dialysis

Time frame: 4-years

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Collaborators

Shahid Beheshti University of Medical Sciences

Registry information

Official study title

Soy-Protein Intake, Cardio-Renal Indices and C-Reactive Protein in Type 2 Diabetes With Nephropathy: a 4-y Randomized Clincal Trial

Important dates

Study start: 2001
Study completion: 2005
First posted: Nov 8, 2007
Registry last updated: Nov 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed