Effect of combined probiotic and selenium supplementation in treatment of coronary heart disease

Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N28

Enrollment

Registered

2018-01-18

Start date

2017-12-29

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Coronary Heart Disease. Chronic ischemic heart disease, unspecified

Interventions

Intervention 1: Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and

Eligibility

Sex/Gender

All

Age

45 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: patients diagnosed with type 2 diabetes and coronary heart disease. Individuals aged 45-85 years.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Selenium, probiotic and/or synbiotic consumption within the last 3 months Patients with thyroid disorders Severe renal insufficiency and hepatic failure Experiencing an acute myocardial infarction and cardiac surgery within the past 3 months

Design outcomes

Primary

Measure	Time frame
Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Secondary

Measure	Time frame
Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Systolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.;Diastolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.	—

Measure

Time frame

Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;Systolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.;Diastolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 6, 2026