The assessment of the effect of omega 3 fatty acids supplementation on serum Irisin, BDNF (Brain
Derived Neurotrophic Factor) and Myonectin in Patients with diabetes type 2 disease
This study is a clinical trial to evaluate the effect of supplementation omega-3 fatty acid on serum levels of Irisin, Myonectin and BDNF on 44 patients with type 2 diabetes in Iran Diabetes Center will be conducted on a voluntary basis this double blind clinical trial is conducted to evaluate the effects of omega 3 fatty acids supplementation on serum levels of Irisin, Myonectin and BDNF in 44 volunteer type 2 diabetic patients of Iran Diabetes Center. Participants divided in two groups of omega 3 fatty acids and placebo recipients based on Permuted Block Randomization. . In 10 weeks duration of this intervention patients will receive omega-3 supplements at a dose of 3750 mg per day (1250 mg per capsule contains omega 3 fatty acids (EPA = 600mg, DHA = 300 mg) and placebo capsules (edible paraffin) at a dose of 3750 mg per day. Thus, each person in the first group receives daily 3 omega 3 fatty acids capsules. In the second group patients received daily 3 placebo capsules contain edible paraffin which are all in the same shape and usage of omega 3 capsules. . Anthropometric measurements and blood pressure will be recorded before and after the intervention. Also, the 24 hours food recalls are be collected and analyzed by the NUT4 software. At the beginning and end of the study 10 ml of patients' blood sample is used to assess the serum concentrations of BDNF, Irisin and Myonectin with ELISA method. Data will be analyzed with Spss version 20.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061922769N3
Registration date:2015-08-16, 1394/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-16, 1394/05/25
Registrant information
Name
Mohammad Hassan Javanbakht
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8891 4462
Email address
mhjavan@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nutritional Sciences & Dietetics,Tehran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the effect of omega 3 fatty acids supplementation on serum Irisin, BDNF (Brain
Derived Neurotrophic Factor) and Myonectin in Patients with diabetes type 2 disease
Public title
The effects of Omega 3 fatty acid supplements on treatment of type 2 diabetes complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetics men and women aged 30-65 years old, ; BMI in the range of 35-25 BMI ranged 25-35; the desire to maintain weight during the study weight maintenance tendency during the study; the tendency to maintain normal activities during the current life style tendency to keep current life style and activities during the study; willingness to cooperate in the project
Exclusion criteria: changing on the dose or types of diabetes medications; inflammatory disease given; unwillingness to continue the cooperation; taking ten percent supplement non using ten or more percent of the supplements; any allergic reactions to omega-3 components
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Depatment of University, Ghods St.,Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2010-06-14, 1389/03/24
Ethics committee reference number
IR.tums.REC.1394.36
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Irisin
Timepoint
The beginning and end of the study (before and after intervention)
Method of measurement
ELISA
2
Description
Myonectin
Timepoint
The beginning and end of the study (before and after intervention)
Method of measurement
ELISA
3
Description
BDNF(Brain Derived Neurotrophic Factor)
Timepoint
The beginning and end of the study (before and after intervention)
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: omega-3 polyunsaturated fatty acid supplements at a dose of 3750 mg per day (1250 mg per capsule of omega-3 polyunsaturated fatty acid is containing (EPA = 600mg, DHA = 300 mg).)
Category
Treatment - Drugs
2
Description
Control group: placebo or (paraffin oral) at a dose of 3750 mg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taban health clinics and Diabetes and Diabetes Research Center
Full name of responsible person
Dr.Mohammad Hasan Javanbakht
Street address
Taban health clinics and Diabetes, No. 100, The northern Derakhti Blvd., Western Dadman Avenue, Shahrake Gharb / Diabetes and Metabolism specialty and subspecialty clinics, Western deadlock Hayat, 17 Shahrivar street, Amirabad street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Sixth Floor, Central Depatment of University, Ghods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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 Nutritional Sciences & Dietetics,Tehran University of Medical Sciences