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

NCT01419912 | Completed Phase 3

• 1 other identifier: soymilk and nephropathy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• soy milk

Secondary Outcomes (19)

• HbA1c

• creatinin

• total cholesterol

• insulin

• systolic blood pressure

Study Arms (2)

soy milk

EXPERIMENTAL

Dietary Supplement: soy milk

cow's milk

EXPERIMENTAL

Dietary Supplement: cow's milk

Interventions

soy milk DIETARY_SUPPLEMENT

soy milk

cow's milk DIETARY_SUPPLEMENT

cow's milk

Eligibility Criteria

• Age: 28 Years - 81 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

Related Publications (1)

• 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.

  PMID: 22787172 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Soy Milk; Milk

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food; Food and Beverages; Dairy Products

Study Design

• Study Type: interventional
• Phase: phase 3
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Last Updated: August 30, 2011

Record last verified: 2011-01

Locations

IR (1)