This research is double blind study that we will examine the overweight and obese person with BMI between 25-35. We take 10 cc blood from participants. we have 3 groups : 25 persons that will eat probiotic yogurt with L.casei DN01 - lactobacillus acidofillus La5- Bifidobacter bb12. With weight reduction diet, 25 persons that will eat probiotic yogurt with L.casei DN01 - lactobacillus acidofillus La5- Bifidobacter bb12. Without weight reduction diet ,25 persons that will eat regular yogurt with weight reduction diet. The duration of intervention is 8 weeks.
IL9-IL4-IL10-IL17-TGF B- IFN - TNF alpha - hsCRP -leptin will measure with ELIZA and real time PCR method. With BIA method we will measure the fat percent of the body of participants (after and before of study).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111082709N21
Registration date:2011-12-20, 1390/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2011-09-17, 1390/06/26
Expected recruitment end date
2012-02-18, 1390/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effects of probiotic yogurt and regular one on balance of Tcells in obese and overwight persons : double blind randomized clinical trial
Public title
effect of probiotics on function of immune system in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age of 20-50;BMI= 25-35;interesting in participation in research; without any metabolic disease , CHD, diabetes , without autoimmune disease , cancer; without infection disease in research ;without allergy for cow s milk; no smoking ; no alcoholism; without immune system suppressor drugs 6 mounts before research; no menstrual bleeding ;without any diet 2 mounts before research ;no consumption food supplementation during research
exclusion criteria: metabolic disease , CHD, diabetes , autoimmune disease , cancer; infection disease in research ; allergy for cow s milk; smoking ; alcoholism; immune system suppressor drugs 6 mounts before research; menstrual bleeding; diet 2 mounts before research; lactose deficiency; food supplementation during research; no interesting for participation
transcription factor of Foxp3 - TGF beta - TNF alpha - GATA3- t-bet -ROR gama IN PBMC
Timepoint
after and before of intervention
Method of measurement
real time- PCR
5
Description
Leptin
Timepoint
after and before of intervention
Method of measurement
ELIZA
6
Description
hsCRP
Timepoint
after and before of intervention
Method of measurement
ELIZA
Secondary outcomes
1
Description
waist circumference
Timepoint
after and before of intervention
Method of measurement
meter
Intervention groups
1
Description
25 overwieght and obese persons with weight reduction and cunsumption of probiotic yogurt with lactobacilus acidophillus La5 and lactobacilus casei DN001 and bifidobacter bb12
Category
Prevention
2
Description
25 overwieght and obese persons with weight reduction and cunsumption of regular yogurt with lactobacilus bulgaricus and Streptococcus thermophilus
Category
Placebo
3
Description
25 overwieght and obese persons without weight reduction and cunsumption of probiotic yogurt with lactobacilus acidophillus La5 and lactobacilus casei DN001 and bifidobacter bb12
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
The clinic of weight managment , Azad university
Full name of responsible person
Zarrati
Street address
Iran zamin street , Sardare jangal street , Poonak square - Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of Medical Science
Full name of responsible person
Mardani
Street address
Centeral Building of Tehran university of medical scienc , Boolvar Keshavarz , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of Medical Science
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
School of Public Health , Tehran University of Medical Science
Full name of responsible person
dr. farzad shidfar
Position
associate professor
Other areas of specialty/work
Street address
Faculty of nutrition , School of Public Health, Alvand street
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health, Tehran University of Medical Science
Full name of responsible person
dr. farzad shidfar
Position
PhD of nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Alvand street
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)