Effect of probiotic supplementation in treatment of coronary heart disease

• Register: IRCT
• Last refreshed on: 5 November 2019
• Main ID: IRCT2017082733941N5
• Date of registration: 2017-09-07
• Prospective Registration: No
• Primary sponsor: Kashan University of Medical Sciences
• Public title: Effect of probiotic supplementation in treatment of coronary heart disease
• Scientific title: Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
• Date of first enrolment: 2017-08-17
• Target sample size: 60
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/26047
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by the use of computer-generated random numbers, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Zatollah Asemi
• Affiliation: Kashan University of Medical Sciences

• Name: Zatollah Asemi
• Affiliation: Kashan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Subjects aged 40-85 years
Patients diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria: Consuming probiotic and/or synbiotic within three months prior to the intervention
Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Taking antibiotics
Having an acute myocardial infarction and a cardiac surgery in the past three months
Renal or hepatic failure

Age minimum: 40 years
Age maximum: 85 years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Heart Disease.
Chronic ischaemic heart disease, unspecified

I25.9

Intervention(s)

Intervention 1: Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally. Intervention 2: Control group: Placebo capsule (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), daily, for 12 weeks orally.

Primary Outcome(s)

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.

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

Secondary Outcome(s)

HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

Malondialdehyde. 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.

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.

Total cholesterol. 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.

Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

Source(s) of Monetary Support

Kashan University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Kashan University of Medical Sciences