Protocol summary

Summary
The current study is a randomized, double-blind, placebo-controlled trial to evaluate the effect of soy milk containing lactobacillus plantarum A7 on inflammatory indices and lipid profile in type 2 diabetic patients with nephropathy. The subjects consist of volunteers with T2DM, who have micro or macro-albuminuria and their GFR is higher than 60 ml/min, they also must not consume any vitamin, mineral or omega-3 supplements 3 weeks before beginning of the trial and during it. Reasons for excluding people from our study are: not adhering to the administrated diet, occurrence of other kidney diseases, cardiac ischemia, gastrointestinal, hepatic or thyroid diseases and acute infections. At the beginning of the study 40 subjects with the abovementioned criteria, will be randomly allocated to the intervention or control groups where they will receive 200 ml/day of soy milk containing L.plantarum or soy milk for 8 weeks. To evaluate the effects of the intervention, serum creatinine, proteinuria, IL-18, serum sialic acid, TNF-α, hsCRP, GFR and lipid profile of the serum will be measured at baseline and after the intervention period and the results will be used to evaluate the probable effectiveness of the intervention to help diabetic patients with nephropathy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601027479N2
Registration date: 2016-01-25, 1394/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Behnood Abbasi
Name of organization / entity
Shahid Beheshti university of medical sciences-National nutrition and food technology research insti
Country
Iran (Islamic Republic of)
Phone
+98 21 8870 4487
Email address
b.abbasi@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of soy milk containing lactobacillus plantarum A7 on inflammatory indices, lipid profile and physical activity in type 2 diabetic patients with nephropathy
Public title
Effect of probiotic supplementation on diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having T2DM ;having micro or macro albuminuria ;GFR higher than 60 ml/min ;not having hepatic gastrointestinal and thyroid diseases ;not having rheumatoid arthritis ;not having any kind of allergy or acute infection ;not consuming vitamin mineral or omega-3 supplements 3 weeks before beginning of the trial and during the trial ;not consuming antibiotics 1 month before the trial and during the trial ;absence of pregnancy or lactating ;not smoking ;not having any specific diet. Exclusion criteria: Not adhering to the administrated diet ;occurrence of other kidney diseases ;cardiac ischemia ;gastrointestinal ;hepatic or thyroid diseases ;acute infection ;needing to be dialysed ;undergoing kidney transplantation ;any kind of surgery or occurrence of pregnancy ;starting to consume drugs that may affect protein excretion such as NSAIDs or ACE-I.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan.
City
Isfahan
Postal code
Approval date
2015-11-02, 1394/08/11
Ethics committee reference number
IR.MUI.REC.1394.3.620

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
E11.21
ICD-10 code description
Glomerular disorders in diabetes mellitus

Primary outcomes

1

Description
Serum creatinine
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , biochemical analysis

2

Description
Proteinuria
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/day, Biochemical analysis

3

Description
IL-18
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
ρg/ml , ELISA

4

Description
Serum sialic acid
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mmol/l , ELISA

5

Description
TNF-α
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
ρg/ml , ELISA

6

Description
hsCRP
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , ELISA

7

Description
GFR
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
ml/min , calculation

8

Description
Serum cholestrol
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , biochemical analysis

9

Description
Serum triglyceride
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , biochemical analysis

10

Description
Serum LDL-C
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , biochemical analysis

11

Description
Serum HDL-C
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , biochemical analysis

12

Description
Physical activity
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
Met-h/wk , Questionnaire

Secondary outcomes

1

Description
Serum sodium
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl ,flame photometry

2

Description
Serum potassium
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl ,flame photometry

3

Description
Fasting blood sugar
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
mg/dl , Biochemical analysis

4

Description
Serum genistein
Timepoint
Before the intervention and 2 months after beginning of the intervention
Method of measurement
nmol/l , TR-FIA

Intervention groups

1

Description
Soy milk containing lactobacillus plantarum A7, 200 cc orally, once a day for 2 months
Category
Treatment - Other

2

Description
Soy milk without lactobacillus plantarum A7 , 200 cc orally, once a day for 2 months
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine and metabolism research center
Full name of responsible person
Behnood Abbasi
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Yahai
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
394620
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Behnood Abbasi
Position
Ph.D. Student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan.
City
Isfahan
Postal code
Phone
+98 31 3792 9776
Fax
Email
b.abbasi@nnftri.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand
Position
Ph.D.
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan.
City
Isfahan
Postal code
Phone
+98 31 3792 9776
Fax
Email
ghiasvand@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Behnood Abbasi
Position
Ph.D. Student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan.
City
Isfahan
Postal code
Phone
+98 31 3792 9776
Fax
Email
b.abbasi@nnftri.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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