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OpenTrials
Completed

NCT Number: NCT01419912

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

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.

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Key information

Age range

28 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Isfahan University of Medical Sciences

Isfahan, Iran

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soy milk

Dietary Supplement

cow's milk

Dietary Supplement

Primary outcomes

  1. soy milk

Secondary outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Important dates

First posted
Aug 18, 2011
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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