View older revisions Content changed at 2019-09-25, 1398/07/03

Protocol summary

Study aim
Study of the effect of synbiotic supplementation on gut microbial, TNF-a and expression of mirRNA-126 and mirRNA-146a in patients with type 2 diabetes
Design
A clinical trial with a control group, with parallel, double-blind, and randomized groups, will be performed on patients with type 2 diabetes. 72 patients will be randomly assigned to receive the synbiotic and the placebo by using a random number table.
Settings and conduct
The study is designed as a double blind randomized controlled trial. After receiving informed consent, the demographic information questionnaire will be completed. At the beginning and end of the study,Biochemical and anthropometric measurements and body composition are performed, diet and physical activity will be evaluated by the three-day record form, Expression of microRNA-126 and microRNA-146a will be measured by RealTime PCR, and serum levels of TNF-a will be measured by ELISA and determination of gut microbiom in participants stool samples will be performed with the use of QPCR.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women with type 2 diabetes, In the age range of 25-65 years, Glycosylated hemoglobin above 6.5% and below 8.5%, BMI 25-35. Exclusion criteria: People with low-immune, pregnant and lactating women, people with special diseases and allergies, inflammatory diseases, and those who use hormone replacement therapy, probiotic consumption or antibiotic treatment within the past month.
Intervention groups
The intervention group will receive synbiotic capsules (containing probiotic, fructo-oligosaccharide as prebiotic, lactose, magnesium stearate, talc) containing 500 mg and the control group will receive placebo (lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day.
Main outcome variables
Expression of microRNA-126 and microRNA-146a, serum levels of TNF-a, gut microbiom(6 microorganism)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180624040228N2
Registration date: 2019-03-27, 1398/01/07
Registration timing: prospective

Last update: 2019-09-25, 1398/07/03
Update count: 1
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Fahime Zeinali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9143
Email address
fghzeinaly@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of synbiotic supplement on microbiome, TNFa and expression of microRNA-126, microRNA-146a in T2DM patients
Public title
Synbiotic and gut microbiome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with type 2 diabetes (the minimum elapsed time of diagnosis is 3 months and diabetes treatment is started in person) Age range 25 to 65 years Glycosylated hemoglobin above 6.5% and below 8.5% BMI is between 25 and 35
Exclusion criteria:
Using alternative therapies with hormone (Insulin, Corticosteroids) or vitamin supplements Chronic kidney, liver, pulmonary diseases. chronic or acute inflammatory diseases (especially acute Pancreatic inflammation and Endocarditis)Valvular disease of the heart. Irritable Bowel Syndrome. Allergic Diabetes complications (Nephropathy, Cardiomyopathy, Retinopathy, Diabetic foot ulcers) People with low immune system (Autoimmune)Pregnancy, Lactation Use of tobacco and alcohol Probiotic consumption or treatment with antibiotics within the past month Follow the unusual diet up to 1month before the study
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
To assign individuals to the intervention and control groups, a random number table will be used. Stratified blocked randomization method will be used based on sex (male and female) and age (25-45 years and 45-65 years), so that the number of samples assigned to each of the groups will be equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Capsules containing synthetic and placebo are similar in shape and appearance and the bottles of Capsules are the same (in terms of color and shape). A and B labels will be fixed on the bottles of Capsules by someone irrelevant to the entire study. participants and researchers will be blinded to the contents in the bottles through out the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Health Faculty, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt
City
yazd
Province
Yazd
Postal code
8915173160
Approval date
2019-03-08, 1397/12/17
Ethics committee reference number
IR.SSU.REC.1397.179

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
gut microbiom
Timepoint
Before and immediately after the intervention
Method of measurement
Quantitative Real time Polymerase Chain Reaction (QPCR) and 16s rRNA sequencing

2

Description
Expression of microRNA-126
Timepoint
Before and immediately after the intervention
Method of measurement
Real time Polymerase Chain Reaction (PCR)

3

Description
Experation of microRNA-146a
Timepoint
Before and immediately after the intervention
Method of measurement
Real time Polymerase Chain Reaction (PCR)

4

Description
Serum levels of tumor necrosis factor alpha
Timepoint
Before and immediately after the intervention
Method of measurement
ELISA kit

Secondary outcomes

1

Description
Triglyceride
Timepoint
Before and immediately after the intervention
Method of measurement
Turbidity test

2

Description
Total cholesterol
Timepoint
Before and immediately after the intervention
Method of measurement
Turbidity test

3

Description
High-density lipoprotein
Timepoint
Before and immediately after the intervention
Method of measurement
Turbidity test

4

Description
Low-density lipoprotein
Timepoint
Before and immediately after the intervention
Method of measurement
Turbidity test

5

Description
Fasting Blood Sugar
Timepoint
Before and immediately after the intervention
Method of measurement
Turbidity test

6

Description
Glycosylated hemoglobin
Timepoint
Before and immediately after the intervention
Method of measurement
Enzymatic Assay Kit

7

Description
fasting insulin
Timepoint
Before and immediately after the intervention
Method of measurement
ELISA kit

Intervention groups

1

Description
Intervention group: Intervention group: The intervention group will receive synbiotic capsules (containing probiotic, fructo-oligosaccharide as prebiotic, lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day.
Category
Prevention

2

Description
Control group: The control group will receive placebo (lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Fahime Zeinali
Street address
Yazd Diabetes Research Center, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3728 0228
Email
drc@ssu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd Diabetes Research Center
Full name of responsible person
Fahime Zeinali
Street address
Yazd Diabetes Research Center, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3728 0228
Email
drc@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Diabetes Research Center
Proportion provided by this source
30
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
Other

2

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fahime Zeinali
Street address
Health Faculty, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
fghzeinaly@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
70
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
Yazd Diabetes Research Center
Full name of responsible person
Fahime Zeinali
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Yazd Diabetes Research Center, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3728 0228
Email
fghzeinaly@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hassan Mozaffari-Khosravi
Position
Professor (Full)
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Health Faculty, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt 8915173160
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
mozaffari.kh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fahime Zeinali
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Health Faculty, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt 8915173160
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
fghzeinaly@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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