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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02704884

Enrollment

Registered

2016-03-10

Start date

2016-03-31

Completion date

Unknown

Last updated

2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetic Patients With Nephropathy

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.

Interventions

DIETARY_SUPPLEMENTprobiotic soy milk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

32 Years to 68 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).
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).

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026