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

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01419912
• Collaborator: (none)
• Location: 1
• Arms: 2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Intervention Model: Crossover Assignment

Arms and Interventions

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Years to 81 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Isfahan University of Medical Sciences	Isfahan		Iran, Islamic Republic of

Sponsors and Collaborators

• Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01419912
• Other Study ID Numbers: soymilk and nephropathy
• First Posted: Aug 18, 2011
• Last Update Posted: Aug 30, 2011
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Aug 30, 2011