Comparison of Soy-milk and Cow Milk Consumption on Inflammatory Factors, Cardiovascular Factors ,Renal Factors, Fibrinolytic Indice and Oxidative Stress Among Type-2 Diabetic Patients With Nephropathy Stage 1 and 2

Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with DN and there are few data about relationship of soy milk consumption and health effect in patients with DN . Therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress; Fibrinolytic Markers; Blood Pressure and Cardiorenal Risk Factors
• Intervention / Treatment: Dietary supplement: soy milk; Dietary supplement: cow's milk

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Isfahan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 81 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults with (>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min )

Exclusion Criteria:

• exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women
• changing dosage of oral hypoglycemic agents
• insulin therapy
• lipid-lowering medications
• use of hormone replacement therapy
• alcohol and cigarette consumption;allergy or intolerance to soybeans or milk
• presence of breast malignant and avoid of advisory diet

Study Plan

How is the study designed?

Design Details

• Interventional Model: CROSSOVER

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: soy milk	Dietary supplement: soy milk
EXPERIMENTAL: cow's milk	Dietary supplement: cow's milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
soy milk

Secondary Outcome Measures

Outcome Measure
HbA1c
total cholesterol
creatinin
insulin
systolic blood pressure
diastolic blood pressure
Malondialdehyde
fibrinogen
Urine creatinine
urine protein
BUN
TNF-α
IL6
FBS
TG
hs-CRP
d-dimer
HDL
LDL

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Publications and helpful links

General Publications

• Miraghajani MS, Esmaillzadeh A, Najafabadi MM, Mirlohi M, Azadbakht L. Soy milk consumption, inflammation, coagulation, and oxidative stress among type 2 diabetic patients with nephropathy. Diabetes Care. 2012 Oct;35(10):1981-5. doi: 10.2337/dc12-0250. Epub 2012 Jul 11.

Study record dates

Study Registration Dates

• First Submitted: August 17, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (ESTIMATE): August 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 29, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: soymilk and nephropathy