The effect of Inulin prebiotic supplementation (inulin or Oligofructose-enriched inulin) on antioxdant status, metabolic, inflammatory and anti-inflammatory factors in type 2 diabetes
This randomized clinical trial is designed to determine the effect of Inulin prebiotic supplementation on antioxidant status, metabolic inflammatory and anti-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 inulin powder or Oligofructose-enriched inulin powder, or control group. The patients in the intervention group will receive 10 g inulin powder /d or 10 g Oligofructose-enriched inulin 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, inflammatory and anti-inflammatory factors and serum lipopolysaccharide 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:IRCT201110293253N4
Registration date:2011-11-15, 1390/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-11-15, 1390/08/24
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
Faculty of Health & Nutrition, Tabriz University of Medical Sciences
Expected recruitment start date
2011-11-16, 1390/08/25
Expected recruitment end date
2012-02-14, 1390/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Inulin prebiotic supplementation (inulin or Oligofructose-enriched inulin) on antioxdant status, metabolic, inflammatory and anti-inflammatory factors in type 2 diabetes
Public title
The effect of Inulin prebiotic supplementation (inulin or Oligofructose-enriched inulin) on type2 diabetic patients
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 and inulin fructans intake ≤200 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)
N/A
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
Faculty of Health & Nutrition, Tabriz University of Medical Sciences
City
tabriz
Postal code
5166614711
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
9044
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 weeks
Method of measurement
24 hours-food recal questionnaire
2
Description
serum antioxidant status
Timepoint
8 weeks
Method of measurement
measurement of SOD,GPX-H,TAC,MDA
3
Description
total grelin level
Timepoint
8 weeks
Method of measurement
Serum level of fasting total grelin
4
Description
lipid profiles
Timepoint
8 weeks
Method of measurement
TC, TG, LDL, HDL
5
Description
insulin level
Timepoint
8 weeks
Method of measurement
Serum level of fasting insulin
6
Description
blood glucose & HbA1c
Timepoint
8 weeks
Method of measurement
fasting blood glucose & HbA1c
7
Description
Inflammatory factors
Timepoint
8 weeks
Method of measurement
HS-CRP,TNF-α,IL-6,IFN-γ
8
Description
Anti-Inflammatory factor
Timepoint
8 weeks
Method of measurement
IL-10
Secondary outcomes
1
Description
Anthropomethric indices
Timepoint
8 weeks
Method of measurement
Weight, Height, BMI.WB,WHR
2
Description
appetite
Timepoint
8 weeks
Method of measurement
questionnaire
3
Description
Lipopolysaccharide
Timepoint
8 weeks
Method of measurement
serum Lipopolysaccharide
4
Description
blood pressure
Timepoint
8 weeks
Method of measurement
blood pressure
Intervention groups
1
Description
Intervention group1: Inulin 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
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
3
Description
Intervention group2: Oligofructose-enriched inulin 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 - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Atiyeh Clinic
Full name of responsible person
DOC Akbar Ali asgharzadeh
Street address
Maralan Square, Azadi Street, East Azarbayjan, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of Medical sciences
Full name of responsible person
Dr. Bahram pourghasem gharghari
Street address
Health and Nutrition Faculty, Tabriz University of Medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Health and Nutrition Faculty, 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
Faculty of Health and Nutrition, 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, Eastern Azerbaijan ,Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 937 139 5660
Fax
+98 41 1334 0634
Email
dehghan.parvin@yahoo.com
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
Dr. Bahram Pourghasem gharghari
Position
PhD in Nutrition Science
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address
Person responsible for updating data
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
+98 937 139 5660
Fax
+98 41 1334 0634
Email
dehghan.parvin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)