Effects of probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium
bb12, and Lactobacillus casei DN001 on serum Omentin ,Nesfatin-1and Adropin in Obese and Overwight people with Low Calorie Diet
Objective: The main objective of this study is to assess the effects of some probiotics on changes in some adipokines secreted by adipose tissue to reduce inflammation in the body in an overweight and obese adult population. Design of study: Randomized, double blind, placebo controlled, single center and phase 2-3 trial. Setting and conduct: 60 overweight or obese volunteer age between 20 -50 years old and BMI between 25 – 35 kg/m2 will be recruited. We have 2 groups: 30 persons that will eat probiotic yogurt with L.casei DN01 - lactobacillus acidofillus La5- Bifidobacter bb12. With weight reduction diet, 30 persons that will eat regular yogurt with weight reduction diet. The duration of intervention is 8 weeks. Main outcome measures: Nesfatin-1, Adropin and Omentin will measure with ELIZA . 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:IRCT201509292709N34
Registration date:2015-10-22, 1394/07/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
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
Iran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-05-20, 1395/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium
bb12, and Lactobacillus casei DN001 on serum Omentin ,Nesfatin-1and Adropin in Obese and Overwight people with Low Calorie Diet
Public title
Effects of probiotic on secreted hormones by adipose tissue in overweight and obese people
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 any diet 2 mounts before research; no consumption food supplementation during research exclusion criteria: metabolic disease, CHD, diabetes, cancer; infection disease in research; allergy for cow s milk; smoking; alcoholism; diet 2 mounts before research; lactose deficiency; food supplementation during research; no interesting for participation
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Not
Secondary trial Id
Not
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.IUMS.REC.1394.26381
Health conditions studied
1
Description of health condition studied
Overweight and Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
fat percent
Timepoint
bigining of the study and ending of 12 weeks
Method of measurement
BIA method
2
Description
BMI
Timepoint
bigining of the study and ending of 12 weeks
Method of measurement
Formula
3
Description
Omentin ,Nesfatin-1 , Adropin
Timepoint
bigining of the study and ending of 12 weeks
Method of measurement
ELIZA
Secondary outcomes
empty
Intervention groups
1
Description
Itrvention group: 30 overwieght and obese persons with weight reduction and cunsumption of probiotic yogurt with lactobacilus acidophillus La5 and lactobacilus casei DN001 and bifidobacter bb12
Category
Placebo
2
Description
control group: 30 overwieght and obese persons with weight reduction and cunsumption of regular yogurt with lactobacilus bulgaricus and Streptococcus thermophilus
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad university clinic of weight managment
Full name of responsible person
Mitra Zarrati
Street address
unit4, First floor, Irane ma Building, No.1, Twenty-fourth Street, Farahani Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. seyed Ali Javad Mousavi . Vice chancellor for research, Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
School of Public Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
professor
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
+98 21 8670 4711
Fax
Email
shidfar.f@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Mitra Zarrati
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Mitra Zarrati
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)