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

Not Applicable

Completed

• Conditions: Type II Diabetic Patients With Nephropathy
• Interventions: Dietary Supplement: probiotic soy milk

• Registration Number: NCT02704884
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Primary Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-11
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
soy milk	probiotic soy milk	200 ml/day soy milk in the control condition
probiotic soy milk	probiotic soy milk	consume a diet containing 200 ml/day probiotic soy milk in intervention group

Primary Outcome Measures

Name	Time	Method
serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)	8 week	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).
cystatin C (Cys- C)	8 week	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).
inflammatory adipokine- Progranulin (PGRN)	8 week	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).
cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1),	8 week	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).

Trial Locations

Locations (1)

Makan Pourmasoumi; 🇮🇷 Tehran, Iran, Islamic Republic of