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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01419912
First received: August 17, 2011
Last updated: August 29, 2011
Last verified: January 2011
  Purpose

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 Intervention 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
Study Design: Intervention Model: Crossover Assignment

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • soy milk

Secondary Outcome Measures:
  • HbA1c
  • creatinin
  • total cholesterol
  • insulin
  • systolic blood pressure
  • diastolic blood pressure
  • Malondialdehyde
  • fibrinogen
  • Urine creatinine
  • urine protein
  • BUN
  • TNF-α
  • IL6
  • FBS
  • TG
  • hs-CRP
  • d-dimer
  • HDL
  • LDL

Arms Assigned Interventions
Experimental: soy milk Dietary Supplement: soy milk
Experimental: cow's milk Dietary Supplement: cow's milk

  Eligibility

Ages Eligible for Study:   28 Years to 81 Years
Genders Eligible for Study:   Both
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:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01419912

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

No publications provided by Isfahan University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01419912     History of Changes
Other Study ID Numbers: soymilk and nephropathy
Study First Received: August 17, 2011
Last Updated: August 29, 2011
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014