1. Home
  2. Approved trials
  3. » فارسی

Clinical trial of prebiotics effect on the level of perceived stress, cortisol, interferon gamma, and appetite in patients with type 2 diabetes.

View the latest revision

History
# Registration date Revision Id
3 2018-11-18, 1397/08/27 68848
2 2018-04-22, 1397/02/02 43654
1 2017-04-02, 1396/01/13 18504
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Secondary outcomes

    #1
    Questioner
    Questionnaire
    #2
    GHRELIN
    GHrelin
    #3
    Questioner
    Questionnaire
    #4
    tryptophan
    Tryptophan
    #5
    quality of life
    quality of sleep
    questioner
    Questionnaire
    #6
    ALP
    Alkaline phosphatase (ALP)
    #7
    ALP
    Alanine aminotransferase (ALT)
    KIT
    Kit
    #8
    AST
    Aspartate aminotransferase (AST)
    KIT
    Kit
    #9
    empty
    total antioxidant capacity
    empty
    فعالیت آنتی اکسیدانی تام
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #10
    empty
    malondialdehyde
    empty
    مالون دی آلدئید
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #11
    empty
    soluble receptor for advanced glycation end-products
    empty
    رسپتور محلول برای فرآورده های نهایی گلیکوزیله
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #12
    empty
    total cholesterol
    empty
    کلسترول تام
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #13
    empty
    triglyceride
    empty
    تری گلیسیرید
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #14
    empty
    LDL
    empty
    لیپوپروتئین با چگالی کم
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #15
    empty
    HDL
    empty
    لیپوپروتئین با چگالی بالا
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #16
    empty
    Catalase
    empty
    کاتالاز
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #17
    empty
    superoxide dismutase
    empty
    سوپراکسید دیس موتاز
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #18
    empty
    glutathione peroxidase
    empty
    گلوتاتیون پراکسیداز
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #19
    empty
    carboxymethyl lysine
    empty
    کربوکسی متیل لیزین
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #20
    empty
    Pentosidine
    empty
    پنتوزیدین
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #21
    empty
    obestatin
    empty
    ابستاتین
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #22
    empty
    brain-derived neurotrophic factor
    empty
    فاکتور نوتروفیک مشتق شده از مغز
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #23
    empty
    Endotoxin
    empty
    ایندوتوکسین
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #24
    empty
    Food intake
    empty
    دریافت های غذایی
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #25
    empty
    Uric acid
    empty
    اسید اوریک
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #26
    empty
    Blood urea nitrogen
    empty
    نیتروژن اوره خون
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    kit
    empty
    کیت
    #27
    empty
    Complete Blood Count
    empty
    شمارش کامل سلول های خونی
    empty
    Before start intervention and 8 weeks after intervention
    empty
    قبل از مداخله و 8 هفته بعد از مداخله
    empty
    Full Diff device
    empty
    دستگاه Full Diff

  • Intervention groups

    #1
    گروه مداخله1: پری بیوتیک (نوتریوز ، روزانه 10 گرم به مدت 8 هفته(
    گروه مداخله1: پری بیوتیک (نوتریوز) ، روزانه 10 گرم به مدت 8 هفته

Protocol summary

Study aim
Determine the effects of prebiotic supplementation on women with type 2 diabetes.
Design
This Randomized, double-blind study to determine the effects of prebiotic supplementation on women with type 2 diabetes will done. Patients were randomly divided to two groups based on block randomization procedure of size six by using random allocation software (RAS). Each block involves the patients with the same categorizes of BMI and age.
Settings and conduct
This randomized, double-blind clinical trial will performed on T2DM from the Iran Diabetes Society
Participants/Inclusion and exclusion criteria
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
Intervention groups
The intervention group: 10g/d resistant dextrin supplement The control group: 10g/d maltodextrin for 8 weeks.
Main outcome variables
Cortisol, Perceived Stress, IL6, IL18, TNF, Leptin, Adiponectin, Insulin, FBS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2016122720965N2
Registration date: 2017-04-02, 1396/01/13
Registration timing: prospective

Last update: 2018-11-30, 1397/09/09
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
2018-03-12, 1396/12/21
Expected recruitment end date
2018-05-22, 1397/03/01
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:
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 and lactating Smokers Consuming prebiotic and probiotics’ products Consuming antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin 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
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
T2DM patients randomly allocated to two groups using a block randomization procedure, after matching of BMI and age.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researcher and patients will not be aware of the type of intervention. The third person will distribute the supplement among patients.
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
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
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
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

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

4

Description
IL18
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

5

Description
Leptin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

6

Description
adiponectin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

7

Description
IL10
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit

8

Description
insulin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

9

Description
TNF
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT

10

Description
IL6
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT

11

Description
FBS
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
KIT

Secondary outcomes

1

Description
Appetite
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questionnaire

2

Description
GHrelin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kite

3

Description
quality of life
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questionnaire

4

Description
Tryptophan
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

5

Description
Kynurenine
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

6

Description
quality of sleep
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questionnaire

7

Description
Alkaline phosphatase (ALP)
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

8

Description
Alanine aminotransferase (ALT)
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit

9

Description
Aspartate aminotransferase (AST)
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Kit

10

Description
total antioxidant capacity
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

11

Description
malondialdehyde
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

12

Description
soluble receptor for advanced glycation end-products
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

13

Description
total cholesterol
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

14

Description
triglyceride
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

15

Description
LDL
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

16

Description
HDL
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

17

Description
Catalase
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

18

Description
superoxide dismutase
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

19

Description
glutathione peroxidase
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

20

Description
carboxymethyl lysine
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

21

Description
Pentosidine
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

22

Description
obestatin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

23

Description
brain-derived neurotrophic factor
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

24

Description
Endotoxin
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

25

Description
Food intake
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Questionnaire

26

Description
Uric acid
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

27

Description
Blood urea nitrogen
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
kit

28

Description
Complete Blood Count
Timepoint
Before start intervention and 8 weeks after intervention
Method of measurement
Full Diff device

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
Atar
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com

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
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 21 3334 0634
Email
Dehghan.nut@gmail.com
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
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
Tabriz university of medical sience
Full name of responsible person
Dehghan
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
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
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
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
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Atar
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Fax
Email
dehghan.nut@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on the baseline characteristics of subjects will be provided in the article.
When the data will become available and for how long
2019
To whom data/document is available
Tabriz University of Medical Sciences
Under which criteria data/document could be used
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
From where data/document is obtainable
Tabriz University of Medical Sciences
What processes are involved for a request to access data/document
The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
Comments
Loading...