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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161022030424N6

Enrollment

Registered

2021-01-25

Start date

2021-02-19

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: The multi strain Probiotic capsule containing Lactobacillus rhamnosus, Lactobacillus Helveticus, Lactobacillus casei, Bifidobacterium lactis, Lactobacillus acidophi

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

neda_dolatkhah@yahoo.com+98 41 3336 1928

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026