The assesment of the effect of low calorie with moderate fiber diet on Brain-derived neurotrophic factor(BDNF) serum levels in obese and overweight type2 diabetic patients with different APO AII- 265T/C polymorphism
Determination of the effect of low energy diet with moderate fiber on the Brain-Driven Neurotrophic Factor (BDNF) in obese and overweight type 2 diabetic patients with different genotypes APO AII-265T / C
Design
A clinical trial study was performed on 56 diabetic patients with moderate-low-energy (moderate-diet) diet and after 6 weeks the serum BDNF level was measured.
Settings and conduct
Patients will receive a low-energy diet and moderate fiber for 6 weeks. Blood samples will be taken at the beginning and at the end of the study (after intervention), which will result in blood sampling of 15-20 ml and level The serum BDNF variable will be measured using commercial kits and by immuno-ELISA method. All phases of the study will be conducted in the laboratory of the Faculty of Health of Tehran University of Medical Sciences. Blind does not take place in this study.
Participants/Inclusion and exclusion criteria
Include criteria: Age range 45 to 65, BMI greater than or equal to 27, Type 2 diabetic patients who do not inject insulin
Non-include criteria: drug use, cigar and other tobacco and alcohol, heart disease, stroke, liver disease, renal failure, thyroid disease, cancer, chronic inflammatory disease, pregnancy and lactation
Intervention groups
Obese and overweight type 2 diabetic patients with genotype CC and TT / TC of APOA2 gene
Main outcome variables
Brain-derived neurotrophic factor(BDNF)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180715040479N1
Registration date:2018-10-02, 1397/07/10
Registration timing:retrospective
Last update:2018-10-02, 1397/07/10
Update count:0
Registration date
2018-10-02, 1397/07/10
Registrant information
Name
Ali Nazary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 6908
Email address
a-nazary@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assesment of the effect of low calorie with moderate fiber diet on Brain-derived neurotrophic factor(BDNF) serum levels in obese and overweight type2 diabetic patients with different APO AII- 265T/C polymorphism
Public title
The assesment of the effect of low calorie with moderate fiber diet on Brain-derived neurotrophic factor(BDNF) serum levels in obese and overweight type2 diabetic patients with different APO AII- 265T/C polymorphism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age range 45 to 65 years
BMI over the 27
Patients with type 2 diabetes who do not inject insulin
Exclusion criteria:
Consumption drugs,tobacco,alcohol
Heart disease, stroke, liver disease, kidney failure, thyroid disease, cancer, chronic inflammatory diseases
consuption anti-inflammatory drugs and multi-vitamin minerals
participate in other interventions
Pregnancy and lactation
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qods Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-06-28, 1397/04/07
Ethics committee reference number
IR.TUMS.VCR.REC.1397.168
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Brain-derived neurotrophic factor (BDNF)
Timepoint
The beginning of the study (before the intervention) and the end of the study (after the intervention)
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Obesity and Overweight
Timepoint
The beginning of the study (before the intervention) and the end of the study (after intervention)
Method of measurement
Scales
Intervention groups
1
Description
Intervention group: This study will be performed on 56 diabetic patients. Patients will have a low-energy and fiber-rich diet (30 g / day) containing 55-65% carbohydrates, 20-25% fat and 15-20% % Protein will be received. After calculating the amount of energy required, the dietary regimen is adjusted daily for each individual. A total of 21 menu items are set with specific energy, and in each week, 7 calorie-like diets are given to people who have the power to select the desired menu and even repeat it per week. Also, the share of energy in each and every one is the same, which allows people to choose between their meals, such as breakfast, their favorite menu. At the beginning and at the end of the study (after intervention), blood samples are collected from patients, thus collecting 15-20 ml of blood.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Laboratory of School of Public Health
Full name of responsible person
Fariba Koohdani
Street address
School of Public Health, Poorsina Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Email
fkoohan@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
School of nutrition and dietitic, Hojjatdoust S, Naderi Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8890 0285
Email
fkoohdan@tums.ac.ir
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba koohdani
Position
professor of cellular and molecular nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of nutrition and dietetics, Hojjadoust S, Naderi Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8898 6908
Email
fkoohdan@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Nazary
Position
Student of Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Dietetics, Hojjatdoust S, Naderi Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8898 6908
Email
a-nazary@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali nazary
Position
Nutrition Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Dietetics, Hojjatdoust S, Naderi Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8898 6908
Email
a-nazary@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All laboratory data of individuals including blood factors, glucose and fat and other measurable factors in the study will be shared.
When the data will become available and for how long
Access to data will be possible for the second half of 1398
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
Statistical analysis related to Trail's studies
Use this data solely to conduct a new research
Use data to write systematic review articles and meta-analyzes
From where data/document is obtainable
Dr Fariba koohdani- fkoohdan@tums.ac.ir
Dr Maasumeh moradi 00989128390869
What processes are involved for a request to access data/document
All results and documentation will be available up to 1 year after the completion of sampling