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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419912
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : August 30, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Inflammation Oxidative Stress Fibrinolytic Markers Blood Pressure and Cardiorenal Risk Factors Dietary Supplement: soy milk Dietary Supplement: cow's milk Phase 3

Study Type : Interventional  (Clinical Trial)
Intervention Model: Crossover Assignment

Arm Intervention/treatment
Experimental: soy milk Dietary Supplement: soy milk
Experimental: cow's milk Dietary Supplement: cow's milk

Primary Outcome Measures :
  1. soy milk

Secondary Outcome Measures :
  1. HbA1c
  2. creatinin
  3. total cholesterol
  4. insulin
  5. systolic blood pressure
  6. diastolic blood pressure
  7. Malondialdehyde
  8. fibrinogen
  9. Urine creatinine
  10. urine protein
  11. BUN
  12. TNF-α
  13. IL6
  14. FBS
  15. TG
  16. hs-CRP
  17. d-dimer
  18. HDL
  19. LDL

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Ages Eligible for Study:   28 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419912

Iran, Islamic Republic of
Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01419912     History of Changes
Other Study ID Numbers: soymilk and nephropathy
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Pathologic Processes