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

Primary Purpose

Type II Diabetic Patients With Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
probiotic soy milk
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetic Patients With Nephropathy

Eligibility Criteria

32 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Makan Pourmasoumi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

probiotic soy milk

soy milk

Arm Description

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

200 ml/day soy milk in the control condition

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 2, 2016
Last Updated
August 11, 2016
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02704884
Brief Title
Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetic Patients With Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotic soy milk
Arm Type
Experimental
Arm Description
consume a diet containing 200 ml/day probiotic soy milk in intervention group
Arm Title
soy milk
Arm Type
Active Comparator
Arm Description
200 ml/day soy milk in the control condition
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic soy milk
Primary Outcome Measure Information:
Title
inflammatory adipokine- Progranulin (PGRN)
Description
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
Title
cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1),
Description
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
Title
serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
Description
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
Title
cystatin C (Cys- C)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Makan Pourmasoumi
City
Tehran
ZIP/Postal Code
1353
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28579313
Citation
Miraghajani M, Zaghian N, Mirlohi M, Feizi A, Ghiasvand R. The Impact of Probiotic Soy Milk Consumption on Oxidative Stress Among Type 2 Diabetic Kidney Disease Patients: A Randomized Controlled Clinical Trial. J Ren Nutr. 2017 Sep;27(5):317-324. doi: 10.1053/j.jrn.2017.04.004. Epub 2017 May 31.
Results Reference
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Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy

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