The aim of this randomized, placebo-controlled trial is to investigate the effects of resistant dextrin powder on serum Levels of Interleukin 4, Interleukin 12 metabolic endotoxima in patients with type 2 diabetes. Eighty patients with type 2 diabetes that their disease was confirmed by pathological assessment will be enrolled in this study according inclusion and exclusion criteria. The participants will be assigned into control and treatment groups using permuted-blocks randomization and will be studied in Double-Blind way. Treatment group will receive 10 gram of resistant dextrin powder daily and Placebo Group will receive 10 gram of maltodextrin daily along with their breakfast and dinner meals for 8 weeks. Demographic information and 24-hour recall Questionnaire will be completed before and 8 weeks after the intervention. Blood Samples (7CC) will be taken before and after the intervention and will be kept under -70 Celsius for the relevant tests .Related biochemical measurements will be done by Elisa Kits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020520965N1
Registration date:2015-02-23, 1393/12/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
dehghanp@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences
Expected recruitment start date
2015-03-19, 1393/12/28
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resitant dextrin prebiotic( nutriose FM06) supplementation on IL4, IL12 and metabolic endotoxima in the patients with type 2 diabetes
Public title
The effect of resitant dextrin prebiotic on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 30-50 years old; 25≤ BMI <35; having diabetes at least 6 months prior to the study; consumption of blood glucose lowering drug; fiber intake <25 g fiber/day.
Exclusion criteria: Consumption of antioxidants supplements during last 3 months; using insulin, pregnancy; lactation; acute renal disease.
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 committee of Tabriz University of Medical Sciences
Street address
Golbad Street, Tabriz, East Azerbayjan, Iran Tabriz East Azerbayjan
City
Tabriz
Postal code
Approval date
2015-01-12, 1393/10/22
Ethics committee reference number
93158
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Endocrine, Nutritional and metabolic diseases
Primary outcomes
1
Description
IL4
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
2
Description
IL12
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
3
Description
LPS
Timepoint
Before and after 8 weeks of intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
BMI
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Weight divided by Height Square
Intervention groups
1
Description
Placebo group will receive 10 gram of maltodextrin powder in the form of 5 gram packs with breakfast and dinner meals for 8 weeks. The supplement will be given monthly and during the consumption possible side effects and keeping on consumption will be monitored.
Category
Placebo
2
Description
Resistant dextrin group will receive 10 gram of Resistant dextrin powder in the form of 5 gram packs with breakfast and dinner meals for 8 weeks. The supplement will be given monthly and during the consumption possible side effects and keeping on consumption will be monitored.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic Clinic
Full name of responsible person
Dr Parvin Dehghan
Street address
Azadi Street, Tabriz, East Azerbaijan, Islamic Republic Of Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Nutrition Faculty, Tabriz University Of Medical Sciences , Attar Neyshabori Street,Tabriz, East Azerbayjan,Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Ph.D
Other areas of specialty/work
Street address
Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan, Islamic Republic Of Iran Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
dehghan.nut@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Ph.D
Other areas of specialty/work
Street address
Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan, Islamic Republic Of Iran
City
Tabriz
Postal code
Phone
+98 41 3337 3673
Fax
Email
dehghan.nut@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Ph.D
Other areas of specialty/work
Street address
Attar Neishabouri Street, Golgasht Street, Tabriz, East Azerbaijan, Islamic Republic Of Iran
City
Tabriz
Postal code
Phone
+98 21 3337 3673
Fax
+98 413364032
Email
dehghan.nut@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)