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

Isfahan University of Medical Sciences48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type II Diabetic Patients With Nephropathy

Interventions

probiotic soy milkDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 32 YearsMax age: 68 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Makan Pourmasoumi

Tehran, Iran

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 8 week

Data from ClinicalTrials.gov

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