We evaluated the effects of soy milk compared to caw’s milk on inflammation and cardiovascular risk factors among over weight and obese female adults. This was a cross-over randomized clinical trial on 24 subjects. 24 non-menopausal women in the age range of 20 to 50 years and body mass index more than 25 kg/m2 participated in this research. All of them were on a weight reducing diet. 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 and caw’s milk period) 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 markers, liver enzymes, blood pressure, lipid profiles, and glycemic control indice evaluated after soy milk period and caw’s milk period .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107052839N3
Registration date:2011-08-15, 1390/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-15, 1390/05/24
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
Tehran univercity of medical science, Esfahan univercity of medical science
Expected recruitment start date
2010-09-06, 1389/06/15
Expected recruitment end date
2011-07-06, 1390/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of soymilk consumption on inflammation, fibrinolytic and cardiovascular risks among overweight and obese female adults
Public title
Effect of soymilk on cardiovascular risk factors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Non-menopausal women in the age range of 20 to 50 years; Body Mass Index more than 25 kg/m2; Not having allergy to soy product or caw’s milk; Not incidencing of chronic or acute diseases ; Consume the medications; Following the research protocol
exclusion criteria: Non-menopausal women in the age range of more than 50 years; Body Mass Index less than 25 kg/m2; Having allergy to soy product or caw’s milk; Incidence of chronic or acute diseases ; Beginning to consume the medications; Not following the research protocol
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Commitee Of Esfahan Univercity Of Medical Science
Street address
Esfahan univercity of medical science
City
Esfahan
Postal code
Approval date
2011-02-04, 1389/11/15
Ethics committee reference number
289249
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
e66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
milk soy
Timepoint
At the begining of the study and 4th,6th,10th weeks
At the begining of the study and 4th,6th,10th weeks
Method of measurement
barometer, digital scales, meter
2
Description
crp، il-6
Timepoint
At the begining of the study and 4th,6th,10th weeks
Method of measurement
biochemical test
3
Description
FBS, LDL, TG, Total cholesterol, HDL
Timepoint
At the begining of the study and 4th,6th,10th weeks
Method of measurement
biochemical test
4
Description
ALT،AST، Fibrinogen، Insulin
Timepoint
At the begining of the study and 4th,6th,10th weeks
Method of measurement
biochemical test
Intervention groups
1
Description
One group had to use diet with soy milk in one period of trial for four weeks. The wash-out period was two weeks. In second intervention had to use diet with cows milk for four weeks.
Category
Other
2
Description
another group had to use diet with cows milk in one period of trial for four weeks. The wash-out period was two weeks. In second intervention had to use diet with soy milk for four weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Univercity Of Medical Sciences
Full name of responsible person
Street address
Isfahan Univercity Of Medical Sciences
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Univercity Of Medical Sciences, Isfahan Univercity 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
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Univercity Of Medical Sciences, Isfahan Univercity 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 Univercity Of Medical Sciences
Full name of responsible person
Leila Azadbakht
Position
Associate Professor
Other areas of specialty/work
Street address
Department Of Community Nutrition, School Of Nutrition And Food Science, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
+98 31 1668 2509
Email
azadbakht@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Univercity Of Medical Sciences
Full name of responsible person
Leila Azadbakht
Position
Associate Professor
Other areas of specialty/work
Street address
Department Of Community Nutrition, School Of Nutrition And Food Science, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
+98 31 1668 2509
Email
azadbakht@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Univercity Of Medical Sciences
Full name of responsible person
Leila Azadbakht
Position
Associate Professor
Other areas of specialty/work
Street address
Department Of Community Nutrition, School Of Nutrition And Food Science, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
+98 31 1668 2509
Email
azadbakht@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)