History
# Registration date Revision Id
3 2019-09-24, 1398/07/02 104932
2 2012-02-12, 1390/11/23 6031
1
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Changes made to previous revision
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Protocol summary

Summary
Objective: The effect of probiotic Gaz enriched with inulin on the biochemical parameters including fasting plasma glucose, lipid profiles, inflammatory factors and stress oxidative in patients with type 2 diabetes. Study design: Randomized, cross-over double blind, control with normal Gaz. Inclusion criteria: Patients with diabetes type 2 with FBS ≥ 126 mg/dl and less than 15 years of their disease and in the aged 35 to 65 years were included. Exclusion criteria: Elective subjects with replace treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory disease, heart valve disease, short bowel syndrome and allergies, patients' with low immune system ability (autoimmune) and pregnant or lactating women, were excluded. population and sample size: 80 patients with type 2 diabetes among eligible people in Golabchi clinic in Kashan. Intervention: These patients were divided to two groups: intervention group (receive 20 g probiotic Gaz enriched with inulin) and normal group: (receive 20 g normal Gaz). After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After 6 weeks of experiment, fasting blood samples were tested again. At the end stage, a 2-week wash-out period was designated. In the this stage, all subjects forbid from taking yoghurt or any other fermented food. Then, groups replace for consume 20 g probiotic Gaz enriched with inulin or 20 g Gaz normal for a 6- weeks. Start and end date of intervention: 14 weeks ( February 27, 2012- June 26, 2012). Baseline outcomes: Serum total cholesterol, LDL-cholesterol, HDL-cholesterol and TG, glucose, insulin, HOMA-IR score, hs-CRP, serum calcium, iron, zinc, Na, K, plasma TAC (total antioxidant capacity) and glutathione.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201195623N1
Registration date: 2012-02-12, 1390/11/23
Registration timing: prospective

Last update:
Update count: 1
Registration date
2012-02-12, 1390/11/23
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University Of Medical Science and Sekkeh Gaz (Isfahan)
Expected recruitment start date
2012-03-17, 1390/12/27
Expected recruitment end date
2012-09-19, 1391/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of synbiotic Gaz on fasting plasma glucose and lipid profiles of diabetic subjects
Public title
Effects of probiotic Gaz enriched with Inolin in diabetes treat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetes type 2 were enrolled with FBS ≥ 126 mg/ dl and less than 15 years of their disease; aged 35 to 65 years. Exclusion Criteria: Elective subjects should not use replace treatments like hormone or supplemental vitamin; patients with chronic kidney disease, liver, lung and chronic or acute inflammatory disease, heart valve disease, short bowel syndrome and allergies; patients' with low immune system ability (autoimmune); pregnant women; lactating women.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University Of Medical Science
Street address
Sahelli Bolvar
City
Qom
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91288

Health conditions studied

1

Description of health condition studied
diabetes- cardiovascular
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting glucose plasma
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
enzymatic

2

Description
Insulin
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
Elisa

3

Description
Total cholesterol
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
Enzymatic

4

Description
TG
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
Enzymatic

5

Description
HDL-c
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
Enzymatic

6

Description
hs-CRP
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
Elisa

7

Description
Total antioxidant
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
spectrophotometer

8

Description
Total glutathione
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
spectrophotometer

9

Description
Serum calcium
Timepoint
The first and end intervention, before and after wash-out
Method of measurement
Enzymatic

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Probiotic Gaz contain of Lactobacillus Acidophilus and Bifidobacterium Bifidum with a total of min 1×107 colony-forming units+%3 Inulin, 10 g, twice a day, 6 weeks
Category
Treatment - Other

2

Description
Control group: Normal Gaz, 10 g, twice a day, 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golabchi Clinic, Kashan
Full name of responsible person
Faraji
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University Of Medical Science
Full name of responsible person
Dr Alireza Kohpeimaie
Street address
Sahelli Bolvar
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University Of Medical Science
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
gaz sekkeh
Full name of responsible person
Dr goharian
Street address
isfahan
City
isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
gaz sekkeh
Proportion provided by this source
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University Of Medical Science
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.ir, asemi_za@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.ir, asemi_za@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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