Comparison of soy-milk and cow milk consumption on inflammatory factors, cardiovascular factors ,renal factors, fibrinolytic indice and oxidative stress among type-2 diabetic patients with nephropathy stage 1 and 2
We evaluated the effects of soy milk compared to caw’s milk on inflammation, oxidative stress, fibrinolytic markers and cardiorenal risk factors among type 2 diabetic patients with nephropathy. Having allergy to soy product or caw’s milk and incidence of chronic or acute diseases were exclusion criterias. There were two trial periods for four weeks (soy milk period with diet containing 0.8 g/kg protein and caw’s milk period diet containing 0.8 g/kg protein ) and a washout period for 2 weeks. In the soy milk period only one glass of soy milk (240 cc) was replaced instead of one glass of caw’s milk (240 cc). In this research antropometric Indicators, inflammatory, oxidative stress and fibrinolytic markers, renal function indices, blood pressure, lipid profiles, and glycemic control indice evaluated after soy milk period and caw’s milk period . This study administrated for 12 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105282839N2
Registration date:2011-09-06, 1390/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-06, 1390/06/15
Registrant information
Name
Leila Azadbakht
Name of organization / entity
Nutrition department, School of health, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2719
Email address
azadbakht@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Esfahan university of medical sciences
Expected recruitment start date
2010-09-06, 1389/06/15
Expected recruitment end date
2011-09-06, 1390/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of soy-milk and cow milk consumption on inflammatory factors, cardiovascular factors ,renal factors, fibrinolytic indice and oxidative stress among type-2 diabetic patients with nephropathy stage 1 and 2
Public title
Effect of soy-milk consumption on inflammatory factors, cardiovascular factors ,renal factors, fibrinolytic indice and oxidative stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included adults with (>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min ); Not having allergy to soy product or caw’s milk. exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women; changing dosage of oral hypoglycemic agents or lipid-lowering medications; alcohol and cigarette consumption;allergy or intolerance to soybeans or milk ;presence of breast malignant and Not following the research protocol.
Age
From 28 years old to 81 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commeitee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
189051
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
n08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus
Primary outcomes
1
Description
soymilk
Timepoint
at baseline and 4,6,10 weeks
Method of measurement
dietary record
Secondary outcomes
1
Description
HbA1c
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
2
Description
creatinin
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
3
Description
total cholesterol
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
4
Description
insulin
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
5
Description
systolic blood pressure
Timepoint
at 1,4,6,10 weeks
Method of measurement
Blood Pressure Monitor
6
Description
diastolic blood pressure
Timepoint
at 1,4,6,10 weeks
Method of measurement
Blood Pressure Monitor
7
Description
Malondialdehyde
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
8
Description
fibrinogen
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
9
Description
Urine creatinine
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
10
Description
urine protein
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
11
Description
BUN
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
12
Description
TNF-α
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
13
Description
IL6
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
14
Description
FBS
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
15
Description
TG
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
16
Description
hs-CRP
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
17
Description
d-dimer
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
18
Description
HDL
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
19
Description
LDL
Timepoint
at 1,4,6,10 weeks
Method of measurement
biochemical analysis
Intervention groups
1
Description
In this randomized crossover design, for 4 weeks و one group consumption cows milk one glass every day .
Category
Other
2
Description
Other group consumptin cow milk 1 glass every day for 4 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
alzahra hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Leila Azadbakht
Street address
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
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
Dr Leila Azadbakht
Position
Associate Prof.
Other areas of specialty/work
Street address
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
Email
Azadbakht@hlth.mui.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
Dr Leila Azadbakht
Position
Associate Proffesor
Other areas of specialty/work
Street address
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
Email
Azadbakht@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
Dr Leila Azadbakht
Position
Associate Prof.
Other areas of specialty/work
Street address
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
Email
Azadbakht@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)