Protocol summary

Study aim
Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes
Design
Sampling method: The initial selection of patients in this study is available and then will be randomly assigned to two groups: Based on the inclusion criteria and with the help of a random number table, an Excel list of 300 patients with a file is prepared. All study samples are explained about the objectives of the study and they are told that they will be included in one of the study groups (test or control). The studied samples are then asked to go to the diabetes clinic and complete the informed consent form to participate in the study. How to randomize: Using the RANDBETWEEN command in Excel software, 40 people are randomly assigned in the test group and 40 people in the control group.
Settings and conduct
All patients with diabetes who have been diagnosed with type 2 diabetes for at least six months and have a record in Yazd Diabetes Clinic will form the research community
Participants/Inclusion and exclusion criteria
All patients with diabetes who have been diagnosed with type 2 diabetes for at least six months and have a file in Yazd Diabetes Clinic will form a research community.
Intervention groups
Individuals in the experimental group received 200 g of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis daily, and individuals in the control group received 200 g of normal yogurt daily (lunch and dinner) for 3 months.
Main outcome variables
Blood sugar/Glycosylated A1C/Cholesterol LDL/HDL/Tri glyceride/

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220226054125N1
Registration date: 2022-07-30, 1401/05/08
Registration timing: retrospective

Last update: 2022-07-30, 1401/05/08
Update count: 0
Registration date
2022-07-30, 1401/05/08
Registrant information
Name
Ali salarisharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
a.salarisharif@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2020-12-20, 1399/09/30
Trial completion date
2021-06-20, 1400/03/30
Scientific title
Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes mellitus: A double-blind randomized controlled trial
Public title
Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes mellitus: A double-blind randomized controlled trial
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria included patients with T2DM low density lipoprotein-cholesterol (LDL-c) equal to or greater than 100 mg/dl age between 30-60 years taking metformin and Gli Banglamide tables with correct gastrointestinal function according to patient not taking blood lipid lowering drugs
Exclusion criteria:
The inclusion criteria included patients with T2DM low density Lipoprotein-cholesterol (LDL-c) equal to or greater than 100 mg/dl age between 30-60 years taking metformin and Gli Banglamide tables with correct gastrointestinal function according to patient not taking blood lipid lowering drugs
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The initial selection of patients in this study is available and will then be randomly assigned to two groups: Based on the inclusion criteria and with the help of a random number table, an Excel list of 300 patients with a file is prepared. The researchers will then establish a list of telephone contacts with the patients in order, and each patient who meets the inclusion and exclusion criteria will be included in the study. This will continue until the desired sample size (80 people) is reached. All study samples are explained about the objectives of the study and they are told that they will be included in one of the study groups (test or control). The studied samples are then asked to go to the diabetes clinic and complete the informed consent form to participate in the study. How to randomize: Using the RANDBETWEEN command in Excel software, 40 people are randomly assigned in the test group and 40 people in the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is designed as a three-way blind. In the first stage, the patient does not know in which group (test or control) he is. People who do blood sampling, not data analysts, do not know what group each person is in (test or control). In this three-blind randomized controlled clinical trial, 80 type 2 diabetic patients with high blood sugar above 100 mg / dL are divided into two groups. The experimental group received 200 g of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis daily and the control group received 200 g of normal yogurt daily (lunch and dinner) for 3 months. Anthropometric indices, blood glucose and serum lipid levels are measured at the beginning and end of the study.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.SSU.REC
Street address
Yazd Diabetic Research Center, at the end of the Art hall alley, Bahnar Square towards Azadi Square, Shahid Sadoughi Blvd, Yazd,Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۹۳۵۷۱
Approval date
2014-11-26, 1393/09/05
Ethics committee reference number
IR.SSU.REC.1393.181431

Health conditions studied

1

Description of health condition studied
Effect of probiotic yogurt consumption on glycemic control and lipid profile in patients with type 2 diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
blood sugar
Timepoint
Before and after study
Method of measurement
Using Pars Azmoun commercial kits

2

Description
Hemoglobin A1c
Timepoint
Before and after study
Method of measurement
Using Pars Azmoun commercial kits

3

Description
cholesterol and Triglyceride
Timepoint
Before and after study
Method of measurement
By photometric method using Pars Azmoun commercial kits

4

Description
HDL
Timepoint
Before and after study
Method of measurement
By photometric method using Pars Azmoun commercial kits

5

Description
LDL
Timepoint
Before and after study
Method of measurement
By photometric method using Pars Azmoun commercial kits

Secondary outcomes

empty

Intervention groups

1

Description
The subjects of the test group receive 200 grams of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis daily for three months.
Category
Treatment - Drugs

2

Description
People in the control group will receive 200 grams of regular yogurt daily (lunch and dinner) for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center affiliated with Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Ali Salari Sharif
Street address
Nursing and Midwifery Research Center Safaieh Bouali St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Fax
+98 35 3824 9705
Email
Microb.5656@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Salar Sharif
Street address
Safaieh Bouali St. Nursing and Midwifery Research Center
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Fax
+98 35 3824 9705
Email
microb.5656@gmail.com
Grant name
Vice Chancellor for Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd
Grant code / Reference number
3713
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd
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
Yazd University of Medical Sciences
Full name of responsible person
Ali Salari Sharif
Position
Reasercher
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Safaieh Bouali St. Nursing and Midwifery Research Center
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Fax
+98 35 3824 9705
Email
microb.5656@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Salarisharif
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
School of Nursing and Midwifery, in front of Reproductive and Infertility Research Institute, Bouali Alley, Timsar Fallahi St, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Fax
+98 35 3824 9705
Email
microb.5656@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali salari sharif
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
School of Nursing and Midwifery, Bouali St, Safaieh Yazd
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Fax
+98 35 3824 9705
Email
microb.5656@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of patients' personal information
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Personal information of the studied samples is unidentified
When the data will become available and for how long
After publishing the article
To whom data/document is available
Access to the results after the publication of the article is possible for everyone
Under which criteria data/document could be used
It is possible to use the data by requesting the following email microb.5656@gmail.com
From where data/document is obtainable
By sending a request to the email of the responsible author
What processes are involved for a request to access data/document
After receiving the email, it will be answered within two weeks
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