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Investigation the effect of Probiotic supplement vs Placebo on anthropometric indices, quality of life, body composition, blood pressure, lipid profile and serum levels of adipokines and atherosclerosis dependent indices in elderlies with type 2 diabetes and high cardiovascular risk

Protocol summary

Study aim
To determine the effect of Probiotic supplement vs Placebo on anthropometric indices, quality of life, body composition, blood pressure, lipid profile, and serum levels of adipokines and atherosclerosis dependent indices in elderly with type 2 diabetes and high cardiovascular risk
Design
A controlled, randomized, triple-blinded, clinical trial with a parallel-group design
Settings and conduct
A single-center clinical trial in the elderlies with type 2 diabetes
Participants/Inclusion and exclusion criteria
Inclusion criteria: > 65 years old, diagnosed as having T2DM, at least moderately controlled diabetes, a stable anti-diabetic drug regimen before starting the study, and high risk for cardiovascular events Exclusion criteria: Consumption of other Probiotic supplements and food products during the study, multivitamin-mineral supplements or medicinal products that interfere with patients' anthropometric indices, blood pressure, lipid profile, and serum levels of adipokines and atherosclerosis dependent indices, cancer, and any chronic disease other than diabetes, smoking, drinking, uncontrolled blood pressure, acute gastrointestinal problem, consumption of antibiotics during the study and unusual stressful event during the study
Intervention groups
Intervention group: Multistrain Probiotics Capsule, containing Lactobacillus rhamnosus, Helveticus, casei, acidophilus, bulgaricus, plantarum and Gasseri and Bifidobacterium lactis, Breve, Langum and bifidum and Streptococcus thermophilus with CFU 109 Manufactured by Zist Takhmir Co. one capsule daily for 4 months Control group: placebo capsule in completely similar design, color, smell, taste and shape to probiotic capsule and without microorganisms, Manufactured by Zist Takhmir Co. one capsule daily for 4 months
Main outcome variables
Changes in anthropometric indices and serum levels of adipokines and serum atherosclerosis associated indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161022030424N6
Registration date: 2021-01-25, 1399/11/06
Registration timing: prospective

Last update: 2021-01-25, 1399/11/06
Update count: 0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of Probiotic supplement vs Placebo on anthropometric indices, quality of life, body composition, blood pressure, lipid profile and serum levels of adipokines and atherosclerosis dependent indices in elderlies with type 2 diabetes and high cardiovascular risk
Public title
Probiotic supplement in elderlies with type 2 diabetes and high cardiovascular risk
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
> 65 years old Diagnosed as having T2DM based on the criterion of the American Diabetes Association At least moderately controlled diabetes (HbA1c<8.5%) A stable anti-diabetic drug regimen (over 4 months) before starting the study Body mass index <45 kg/m2 High risk of cardiovascular events: Albuminuria in two of three random urine samples in the last 24 hours and a positive history of macrovascular events
Exclusion criteria:
Consumption of other Probiotic supplements and food products during the study Multivitamin-mineral supplements or medicinal products that interfere with patients' anthropometric indices, blood pressure, lipid profile, and serum levels of adipokines and atherosclerosis dependent indices Cancer and any chronic disease other than diabetes Smoking Drinking Uncontrolled blood pressure Uncontrolled severe diabetes Acute gastrointestinal problem Consumption of antibiotics during the study Unusual stressful event during the study
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS) with block sizes of 2and 4. Similarly sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Triple blinded
Blinding description
Probiotic and placebo supplements will be prepared in exactly the same way in terms of shape, color and odor, and will be placed in a small envelope containing 30 to 31 capsules for each participant for monthly consumption. The envelopes will be opened in the order in which the participants enter this stage from number 1, and an envelope containing the supplement will be provided to the participant for one month. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study
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
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3654895785
Approval date
2020-12-28, 1399/10/08
Ethics committee reference number
IR.TBZMED.REC.1399.917

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
5A11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Weight
Timepoint
Measurement of the weight at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
SECA digital scale

2

Description
Body mass index
Timepoint
Measurement of the body mass index at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Calculation (division of weight in kilograms by height squared in meters)

3

Description
Resistin
Timepoint
Measurement of the Resistin at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

4

Description
Chemerin
Timepoint
Measurement of the Chemerin at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

5

Description
Vascular cell adhesion molecule (VCAM)-1
Timepoint
Measurement of the Vascular cell adhesion molecule (VCAM)-1 at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

6

Description
Intercellular adhesion molecule (ICAM)-1
Timepoint
Measurement of the Intercellular adhesion molecule (ICAM)-1at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

7

Description
E-selectins
Timepoint
Measurement of the E-selectins at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

Secondary outcomes

1

Description
Quality of life
Timepoint
Evaluation of the quality of life at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
LEIPAD quality of life questionnaire

2

Description
Blood pressure
Timepoint
Measurement of the blood pressure at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Mercury barometer

3

Description
Blood Triglyceride
Timepoint
Measurement of the blood Triglyceride at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

4

Description
Blood total Cholesterol
Timepoint
Measurement of the blood total Cholesterol at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

5

Description
Blood LDL Cholesterol
Timepoint
Measurement of the blood LDL Cholesterol at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

6

Description
Blood HDL Cholesterol
Timepoint
Measurement of the blood HDL Cholesterol at the beginning of the study (before the intervention) and 4 months after the start of Probiotic supplementation
Method of measurement
Biochemical analysis

Intervention groups

1

Description
Intervention group: The multi strain Probiotic capsule containing Lactobacillus rhamnosus, Lactobacillus Helveticus, Lactobacillus casei, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium Breve, Lactobacillus bulgaricus, Bifidobacterium Langum, Lactobacillus plantarum, Bifidobacterium bifidum, Lactobacillus Gacery and Streptococcus thermophilus to the CFU 109 manufactured bt Zist Takhmir Co. once daily for 4 months
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule with completely similar appearance characteristics including shape, color, smell and taste to probiotic capsule without microorganisms manufactured bt Zist Takhmir Co. once daily for 4 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Neda Dolatkhah
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5986365489
Phone
+98 41 3334 4280
Fax
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

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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