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

NCT ID: NCT01419912

Last Updated: 2011-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

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.

Conditions

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

Study Design

• Intervention Model: CROSSOVER

Study Groups

soy milk

Group Type: EXPERIMENTAL

soy milk

Intervention Type: DIETARY_SUPPLEMENT

cow's milk

Group Type: EXPERIMENTAL

cow's milk

Intervention Type: DIETARY_SUPPLEMENT

Interventions

soy milk

Intervention Type: DIETARY_SUPPLEMENT

cow's milk

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Locations

Isfahan University of Medical Sciences

Isfahan, , Iran

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 22787172 (View on PubMed)

Other Identifiers

soymilk and nephropathy

Identifier Type: -

Identifier Source: org_study_id