Effect of Lactobacillus rhamnosus and inulin supplements (alone and in combination) in patients with coronary artery disease

Comparison of the efficacy of Lactobacillus rhamnosum and inulin supplements (alone and in combination) in inflammatory markers, oxidative stress, microbial transport, intestinal metabolites and gene expression of endocannabinoid CB1 and CB2 receptors in patients with coronary artery disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180712040438N4

Enrollment

Registered

2020-03-10

Start date

2020-02-09

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

Coronary stenosis. Atherosclerotic heart disease of native coronary artery

Interventions

Intervention 1: Patients in this group will receive pro-inulin and probiotic supplements for 8 weeks. Inulin will be given in 10 grams of medicated sachets and the target group will consume once daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with coronary artery stenosis body mass index is between 25-35 kg/m2

Exclusion criteria

Exclusion criteria: Heart failure or cardiac output less than 30% Supplement intolerance Patient decision to exclude study

Design outcomes

Primary

Measure	Time frame
Vascular cell adhesion molecule 1. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Intercellular Adhesion Molecule 1. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Toll-like receptor 4. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Lipopolysaccharides. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Trimethylamine N-oxide. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Interlukin-6. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;High-sensitivity C-reactive Protein. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Cannabinoid receptor type 1. Timepoint: Baseline and 8 week after intervention. Method of measurement: gene expression.;Cannabinoid receptor type 2. Timepoint: Baseline and 8 week after intervention. Method of measurement: gene expression.;Malondialdehyde. Timepoint: Baseline and 8 week after intervention. Method of measurement: spectrophotometry.;Total antioxidant capacity. Timepoint: Baseline and 8 week after intervention. Method of measurement: spectrophotometry.;Depression. Timepoint: Baseline and 8 week after intervention. Method of measurement: Beck questionnaire.;Quality of Life. Timepoint: Baseline and 8 week after intervention. Method of measurement: McNew Questionnaire.	—

Measure

Time frame

Vascular cell adhesion molecule 1. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Intercellular Adhesion Molecule 1. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Toll-like receptor 4. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Lipopolysaccharides. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Trimethylamine N-oxide. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Interlukin-6. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;High-sensitivity C-reactive Protein. Timepoint: Baseline and 8 week after intervention. Method of measurement: ELISA.;Cannabinoid receptor type 1. Timepoint: Baseline and 8 week after intervention. Method of measurement: gene expression.;Cannabinoid receptor type 2. Timepoint: Baseline and 8 week after intervention. Method of measurement: gene expression.;Malondialdehyde. Timepoint: Baseline and 8 week after intervention. Method of measurement: spectrophotometry.;Total antioxidant capacity. Timepoint: Baseline and 8 week after intervention. Method of measurement: spectrophotometry.;Depression. Timepoint: Baseline and 8 week after intervention. Method of measurement: Beck questionnaire.;Quality of Life. Timepoint: Baseline and 8 week after intervention. Method of measurement: McNew Questionnaire.

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Secondary

Measure	Time frame
Assessment of gut microbiota. Timepoint: At the baseline and after intervention. Method of measurement: Via real time PCR.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Jalal Moloudi

Kermanshah University of Medical Sciences

jmoludi@yahoo.com+98 83 3710 2008

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 15, 2026