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

Phase 3

Completed

• Conditions: Inflammation; Oxidative Stress; Fibrinolytic Markers; Blood Pressure and Cardiorenal Risk Factors
• Interventions: Dietary Supplement: cow's milk; Dietary Supplement: soy milk

• Registration Number: NCT01419912
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cow's milk	cow's milk	-
soy milk	soy milk	-

Primary Outcome Measures

Name	Time	Method
soy milk

Secondary Outcome Measures

Name	Time	Method
HbA1c
creatinin
total cholesterol
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

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of