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IRCT20161022030424N6 IRCT 2021-01-25 Tabriz University of Medical Sciences Probiotic supplement in elderlies with type 2 diabetes and high cardiovascular risk 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 2021-02-19 anticipated 80 Complete https://irct.ir/trial/53764 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Type 2 diabetes mellitus. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences scientific Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) > 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 65 years no limit Both 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 5A11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs 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 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 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. 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). 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Tabriz University of Medical Sciences Approved 2020-12-28 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)