Objectives : Determine the effects of prebiotic supplementation on women with type 2 diabetes. This Randomized, double-blind study to determine the effects of prebiotic supplementation on the level of perceived stress, cortisol, ghrelin, INFY levels and appetite among 80 women with type 2 diabetes will done. Patients were randomly divided to two groups. The randomization was performed based on block randomization procedure of size six. Afterwards to match the groups, each block involves the patients with the same categorizes of BMI and age. The allocation sequence was randomly generated by random allocation software (RAS). The intervention group will receive 10g/d resistant dextrin supplement and the control group will receive similar amounts of maltodextrin as placebo for 8 weeks. Supplements were divided in to two packages of 5 g each to be taken during breakfast and dinner with a cup of water.Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl.
Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d.. Primary outcomes including perceived stress, cortisol, interfron gamma and secondary outcomes including ghrelin, and appetite.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122720965N2
Registration date:2017-04-02, 1396/01/13
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2017-04-02, 1396/01/13
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
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-03-11, 1395/12/21
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of prebiotics effect on the level of perceived stress, cortisol, interferon gamma, and appetite in patients with type 2 diabetes.
Public title
Prebiotic effect in patients with type 2 diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: having type 2 diabetes for more than six months according International Diabetes Federation (fasting blood sugar level more than 126 mg/dl), using anti-diabetic drugs and maintaining them in the period of the study, having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months.
Exclusion criteria: having history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; pregnancy; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and having a typical fiber intake more than 30g/d.
Age
From 30 years old to 50 years old
Gender
Female
Phase
2
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
Randomized block
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.TBZMED.REC.1395.949
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E10, E11
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Cortisol
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit
2
Description
Interfron gamma
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit
3
Description
Perceived stress
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Perceived stress questionnaire
Secondary outcomes
1
Description
Appetite
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questionear
2
Description
GHRELIN
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kite
Intervention groups
1
Description
Intervention group 1 : prebiotic (Nutriose,10g/d, for 8 weeks)
Category
Treatment - Other
2
Description
Intervention group 2 (placebo): Matodextrin (matodextrin ,10g/d, for 8 weeks)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dehghan
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reserach, Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserach, 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 sience
Full name of responsible person
Dehghan
Position
PhD
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 7581
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
PhD
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Postal code
Phone
+98 41 3335 7581
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
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)