This randomized clinical trial is designed to determine the effect of resistant starch and nutriose FM06 supplementation on antioxidant status and metabolic inflammatory factors in type 2 diabetes. A total of sixty six patients with type 2 diabetes will be randomly assigned into one of 3 groups including two 22-patient intervention groups receiving resistant starch powder or nutriose FM06 powder, or control group. The patients in the intervention group will receive 10 g resistant starch powder /d or 10 g nutriose FM06 powder /d for two months while those in the control group will receive 10 dextrin maltose/d for two months. Daily supplements will be divided into 2 portions of 5g each to be eaten during breakfast and dinner. The antioxidant status, metabolic and inflammatory factors will be measured before and after the study. Also, to assessment the food intake and appetite, 24 hours food recall and appetite questionnaire will be completed before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110293253N5
Registration date:2012-01-25, 1390/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-25, 1390/11/05
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz MedicalSience University
Country
Iran (Islamic Republic of)
Phone
+98 937 139 5660
Email address
bahrampg@yahoo.com
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center Of Tabriz University Of Medical Sciences
Expected recruitment start date
2012-01-19, 1390/10/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistant starch and nutriose FM06 supplementation on antioxdant status, metabolic and inflammatory factors in type 2 diabetes
Public title
The effect of resistant starch and nutriose FM06 supplementation in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 30-65 years old, 25≤ BMI <35, having diabetes at least 6 months prior to the study, consumption of blood glucose lowering drug,. typical fiber intake <25 g fiber/d Exclusion criteria: consumption of antioxidants supplements during last 3 months prior to the study, using insulin, pregnancy, lactation, acute renal disease
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
The Research Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2012-01-14, 1390/10/24
Ethics committee reference number
9073
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
dietary intake
Timepoint
8 week
Method of measurement
24 hours-food recal questionnaire
2
Description
serum antioxidant status
Timepoint
8 week
Method of measurement
measurement of SOD,GPX-H,TAC,MDA
3
Description
lipid profiles
Timepoint
8 week
Method of measurement
TC, TG, LDL, HDL
4
Description
insulin level
Timepoint
8 week
Method of measurement
Serum level of fasting insulin
5
Description
blood glucose & HbA1c
Timepoint
8 week
Method of measurement
fasting blood glucose & HbA1c
6
Description
Inflammatory factors
Timepoint
8 week
Method of measurement
HS-CRP,TNF-α,IL-6
Secondary outcomes
1
Description
appetite
Timepoint
8week
Method of measurement
questionnaire
2
Description
Anthropomethric indices
Timepoint
8week
Method of measurement
Weight, Height, WB,WHR
3
Description
blood pressure
Timepoint
8 week
Method of measurement
blood pressure
Intervention groups
1
Description
Intervention group1: resistant starch powder 10 g (2*5 gr)/d, divided into 2 portions of 5g each to be eaten during breakfast and dinner, for two months
Category
Treatment - Other
2
Description
Intervention group2: nutriose FM06 powder 10 g (2*5 gr)/d, divided into 2 portions of 5g each to be eaten during breakfast and dinner, for two months
Category
Treatment - Other
3
Description
Placebo group: dextrin maltose 10 g (2*5 gr)/d, divided into 2 portions of 5g each to be eaten during breakfast and dinner, for two months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Atiyeh Clinic
Full name of responsible person
Dr. Bahram pourghasem gharghari
Street address
Maralan Square, Azadi Street, East Azarbayjan, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Research Center, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. alireza Ostadrahimi
Street address
Block B, Third Floor, Health And 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
Nutritional Research Center, 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
Nutritional Research Center, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Bahram Pourghasem gharghari
Position
PhD in Nutrition Science
Other areas of specialty/work
Street address
Tabriz Medical University
City
Tabriz
Postal code
3341113
Phone
+98 41 1334 1113
Fax
Email
pourghassemb@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Ph.D. Student in Nutrition Science
Other areas of specialty/work
Street address
Faculty of Health and Nutrition, Attare Neishabouri street, Golgasht street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1334 0634
Fax
Email
dehghan.parvin@yahoo.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. Student in Nutrition Science
Other areas of specialty/work
Street address
Faculty of Health and Nutrition, Attare Neishabouri street, Golgasht street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
00
Fax
Email
dehghan.parvin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)