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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

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.

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Detailed Description

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Conditions

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Type II Diabetic Patients With Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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probiotic soy milk

consume a diet containing 200 ml/day probiotic soy milk in intervention group

Group Type EXPERIMENTAL

probiotic soy milk

Intervention Type DIETARY_SUPPLEMENT

soy milk

200 ml/day soy milk in the control condition

Group Type ACTIVE_COMPARATOR

probiotic soy milk

Intervention Type DIETARY_SUPPLEMENT

Interventions

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probiotic soy milk

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

32 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Makan Pourmasoumi

MSc student, Principal Investigator, Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran

Responsibility Role PRINCIPAL_INVESTIGATOR