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

Inflammation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419912
• Other study ID #: soymilk and nephropathy
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2011
• Last updated: August 29, 2011

Study information

• Verified date: January 2011
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 28 Years to 81 Years

Eligibility

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

Intervention Model: Crossover Assignment

Related Conditions & MeSH terms

• Blood Pressure and Cardiorenal Risk Factors
• Fibrinolytic Markers
• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• soy milk

• cow's milk

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	soy milk
Secondary	HbA1c
Secondary	creatinin
Secondary	total cholesterol
Secondary	insulin
Secondary	systolic blood pressure
Secondary	diastolic blood pressure
Secondary	Malondialdehyde
Secondary	fibrinogen
Secondary	Urine creatinine
Secondary	urine protein
Secondary	BUN
Secondary	TNF-a
Secondary	IL6
Secondary	FBS
Secondary	TG
Secondary	hs-CRP
Secondary	d-dimer
Secondary	HDL
Secondary	LDL