Protocol summary

Study aim
Determination of the Effect of Synbiotic Supplementation on Glycemic Factor, Lipid Profile, Total Antioxidant Capacity and Serum Inflammatory Factors in Patients with Type 1 Diabetes
Design
In this double-blind trial study, 50 subjects were selected based on entry and exit criteria for participation in this study. Using simple random sampling, they were randomly divided into two groups of 25 intervention and control group.
Settings and conduct
This is a clinical trial study done on type 1 diabetic patients referred to an endocrinologist clinic in 1397. The proposed patients are coded by a third party health care provider who does not know anything about the research, and researchers and patients also do not have information about the contents of the packages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 1 diabetes. Exit criteria: Unwillingness to participate in the study, kidney disease, coronary arteries, acute and chronic lung inflammation, short stomach cyst syndrome, allergy, travel more than 2 weeks, smokers, use of food supplements, anti-inflammatory drugs, use of any antioxidant supplements in the last 3 months, use of medications Immune suppressants, follow special diets, change diet or decide to lose weight
Intervention groups
Patients (50 people) are randomly divided into two groups of 25. In the intervention group, 1 gramme of synbiotic supplement from the Parsi Lakt Shiraz Company (cfu 109 Lactobacillus spurogenesis and cfu 1010 Bifidobacterium as probiotic and inulin as a periwist) with a glass of water once a day after lunch for a period of 8 weeks. In the control group, patients receive 1 g of starch with a glass of water once a day after lunch for 8 weeks.
Main outcome variables
Fasting blood glucose, serum insulin, HbA1c, lipid factor TG, Chol-T, LDL-c, HDL-c, total antioxidant capacity (TAC) and inflammatory factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180310039020N1
Registration date: 2018-05-11, 1397/02/21
Registration timing: prospective

Last update: 2018-05-11, 1397/02/21
Update count: 0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Mona Jamalvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3777 8206
Email address
jamalvandi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic supplementation on glycemic factor, lipid profile, Total antioxidant capacity and serum inflammatory factors in patients with type 1 diabetes.
Public title
Effect of synbiotic in diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All of type 1 diabetes who have at least 1 year of diagnosis َAccording to BMI for age chart, their body mass index is below 95%
Exclusion criteria:
Unwillingness of patients to participate in the study Renal diseases, coronary arteries, acute and chronic inflammation of the lungs, short stomach cyst syndrome, allergies, pregnancy, lactation Traveling for more than 2 weeks Smokers, the use of food supplements, anti-inflammatory drugs, the use of any antioxidant supplements in the last 3 months, the use of immunosuppressive drugs Follow certain diets, change your diet or decide to lose weight
Age
From 4 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
First of all, individuals who have the characteristics necessary to enter the study are usually taken from a non-random sample using a simple sampling method. Then, randomization is done between study groups. In this study, a block randomization method (block 4) is used. One of the study colleagues who did not have blindfolded, named synbiotic and placebo with the letters A and B (for example). Then, the researcher distributed A and B packages among the patients referring to the study in the office by random blocking (ABAB, BABA, AABB, ABBA, ABBA, BAAB) by randomized blocking (First person A, Second person B, third person A, fourth person B, ...). Then, blocks are created so that blocks are randomly selected to reach the required sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, it is given to a powder control group that is similar in appearance to the supplement in the treatment group (intervention), which has no effective substance (placebo or placebo). In this study, coding will be done by a third person from health care providers who do not know anything about this research, and researchers and patients will not be aware of the contents of the packets.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Jundishapur University of Medical Sciences Ahwaz
Street address
Iran, Khuzestan, Ahvaz, Ave. Golestan, Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.AJUMS.REC.1396.1032

Health conditions studied

1

Description of health condition studied
type1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

Primary outcomes

1

Description
Blood sugar in the morning
Timepoint
Before and after the intervention
Method of measurement
Use of the kit in an enzymatic method

2

Description
HbA1C
Timepoint
Before and after the intervention
Method of measurement
Use of the kit in an enzymatic method

3

Description
LDL cholesterol
Timepoint
Before and after the intervention
Method of measurement
Use of the kit in an enzymatic method

4

Description
HDL cholesterol
Timepoint
Before and after the intervention
Method of measurement
Use of the kit in an enzymatic method

5

Description
Tri glyceride
Timepoint
Before and after the intervention
Method of measurement
Use of the kit in an enzymatic method

6

Description
Total cholesterol
Timepoint
Before and after the intervention
Method of measurement
Use of the kit in an enzymatic method

7

Description
TNF-α
Timepoint
Before and after the intervention
Method of measurement
Eliza

8

Description
hs-CRP
Timepoint
Before and after the intervention
Method of measurement
Eliza

9

Description
TAC
Timepoint
Before and after the intervention
Method of measurement
Eliza

10

Description
Insulin serum
Timepoint
Before and after the intervention
Method of measurement
Elisa

11

Description
Insulin resistance (HOMA-IR)
Timepoint
Before and after the intervention
Method of measurement
Elisa

12

Description
IL-6
Timepoint
Before and after the intervention
Method of measurement
Elisa

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group consumes 1 g of synbiotic supplement with a glass of water once a day after lunch for 8 weeks.
Category
Other

2

Description
Control group: In the control group, patients take 1 g of starch with a glass of water once a day after lunch for 8 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Private Doctor Endocrinologist
Full name of responsible person
Mona jamalvandi
Street address
golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 1988
Email
jamalvandi.m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvī
Street address
Jundishapur University of Medical Sciences, Ave. Golestan, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
jamalvandi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mona jamalvandi
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Jundishapur University of Medical Sciences, Ave. Golestan, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
jamalvandi.m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Aَhmad zare javid
Position
Faculty Member of Ahvaz Jundishapur University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Jundishapur University of Medical Sciences, Ave. Golestan, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
87433331257
Phone
+98 74 3333 1257
Email
zarejavid-a@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mona jamalvandi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Jundishapur University of Medical Sciences, Ave. Golestan, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
jamalvandi.m@ajums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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