Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy

Study Overview
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Brief Summary
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The aim of the present study was to determine the effects of fortified soy milk with L. planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II diabetic patients with nephropathy.

Conditions
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Type II Diabetic Patients With Nephropathy

Intervention / Treatment
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* Dietary Supplement: probiotic soy milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Type 2 diabetic patients with stages 1 and 2 of nephropathy (defined as meeting criteria including fasting blood glucose >126 mg/dL, hypoglycemic agents, or insulin intake, proteinuria >300 mg/day, and glomerular filtration rate >90 mL/min) Exclusion Criteria: pregnancy or lactating in women allergy or intolerance to soy milk or avoidance of soy milk consumption smoking, alcoholism recent antibiotic therapy and using of supplements containing vitamins and minerals any medical condition such as inflammatory bowel disease, infection, liver disease and rheumatoid arthritis.

Ages Eligible for Study
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Minimum Age: 32 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic soy milk<br>consume a diet containing 200 ml/day probiotic soy milk in intervention group | Dietary Supplement: probiotic soy milk<br> <br> |
| Active Comparator: soy milk<br>200 ml/day soy milk in the control condition | Dietary Supplement: probiotic soy milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory adipokine- Progranulin (PGRN) | PGRN will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China). | 8 week | 
| cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1), | sTNFR1 will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China). | 8 week | 
| serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) | NGAL will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China). | 8 week | 
| cystatin C (Cys- C) | Cys- C will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China). | 8 week |