Clinical trial on the effect of kind of fermented milk on cardiometabolic risk factors, insulin resistance, some incretin hormones and related immunologic/inflammatory markers in 11-18-years-old adolescents with metabolic syndrome
In this triple blind randomized clinical trial, after obtaining parent's informed consent and subject's assent, sixty 11-18 year-old eligible adolescents will be grouped into two arms using computerized block randomization (by sex and age group)(primary plan).The intervention will be 2 months consuming of fermented camel milk, 250(500) cc daily with major meals. the control subjects will receive fermented cow milk with similar taste and appearance. Outcome variables will be checked during the week before and the week after 2 months intervention. Three days food record and physical activity questionnaire will be used at baseline.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508081202N2
Registration date:2015-09-19, 1394/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-19, 1394/06/28
Registrant information
Name
Zahra Fallah
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3321
Email address
z_fallah@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellory for research and technology Isfahan University of Medical sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the effect of kind of fermented milk on cardiometabolic risk factors, insulin resistance, some incretin hormones and related immunologic/inflammatory markers in 11-18-years-old adolescents with metabolic syndrome
Public title
Effect of a kind of fermented milk on metabolic syndrome in adolescents
Purpose
Prevention
Inclusion/Exclusion criteria
Major inclusion criteria:
11-18 years old; both genders; Iranian nationality; diagnosed with Metabolic syndrome.
Major exclusion criteria:
other diseases; not consuming milk product for more than 3 consecutive or 7 intermittent days; side effects like allergic reactions.
Age
From 11 years old to 18 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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
If the patient recruitment lasts too long, the parallel assignment will be changed to crossover. If good compliance is guaranteed, the amount of fermented milk will be raised to 500 cc daily.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan regional ethics commitee
Street address
Isfahan University of Medical Sciences, Hezarjerib Avenue
City
Isfahan
Postal code
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
193059
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Selected cardiometabolic risk factors
Timepoint
During the week before and the week after 2 months intervention
Method of measurement
Blood biochemistry and physical examinations
Secondary outcomes
1
Description
Insulin resistance level
Timepoint
During the week before and the week after 2 months intervention
Method of measurement
Blood test and calculation
2
Description
Incretine hormones level
Timepoint
During the week before and the week after 2 months intervention
Method of measurement
Blood test
3
Description
Some immuno/inflammatory biomarkers
Timepoint
During the week before and the week after 2 months intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention: 250 cc fermented camel milk daily for 2 months
Category
Treatment - Other
2
Description
Control:250-500 cc fermented cow milk daily for two months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Dr. Zahra Fallah
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Vice chancellory for Research-Building No 4, Isfahan university of Medical Sciences, Hezarjerib Avenue
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. Zahra Fallah
Position
GP / PhD student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Postal code
Phone
+98 31 3792 3321
Fax
Email
z_fallah@mail.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
Prof. Roya Kelishadi
Position
Pediatrician
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Postal code
Phone
+98 31 3792 3320
Fax
Email
roya.kelishadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Fallah
Position
GP/ PhD student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 3792 3321
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)