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IRCT20180712040438N4 IRCT 2020-03-10 Kermanshah University of Medical Sciences 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 2020-02-09 anticipated 96 Complete https://irct.ir/trial/45357 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From among the patients who volunteer to participate in the study, 96 individuals will be selected by simple random sampling. Then by using the Random Allocation Software, the subjects will be allocated into one of the groups of inulin, probiotic, inulin-probiotic combination or placebo, stratified by sex and age. The sequence of randomization will be kept in a safe place by an independent party and is not aware of the study, Blinding description: In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Capsules , will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company. 3 Coronary stenosis. 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 after lunch. Lactobacillus rhamnosus will provide 1.6× 10^10 colony forming units (CFU) bacterial drug capsules and the target group will consume one capsule daily. To ensure supplement consumption, patients will be contacted weekly. The Quality of Life Questionnaire (McNEW) and Depression Inventory (Beck) were also completed. Intervention 2: Intervention group: Patients in this group will receive pro-inulin supplement for 8 weeks. Inulin will be given in 10 grams of medicated sachets and the target group will consume once daily after lunch. In addition, a placebo capsule containing maltodextrin as a placebo for Lactobacillus rhamnosus will consume one post-meal daily. To ensure supplement consumption, patients will be contacted weekly. The Quality of Life Questionnaire (McNEW) and Depression Inventory (Beck) were also completed. Intervention 3: Intervention group: Patients in this group will receive probiotic supplements for 8 weeks. Lactobacillus rhamnosus will provide 1.6× 10^10 colony forming units (CFU) bacterial drug capsules and the target group will consume one capsule daily. In addition, they will consume a single dose of maltodextrin replacement inulin daily after lunch. To ensure supplement consumption, patients will be contacted weekly. The Quality of Life Questionnaire (McNEW) and Depression Inventory (Beck) were also completed. Intervention 4: Control group: Patients in this group receive an injection of maltodextrin daily with inulin and a placebo capsule containing maltodextrin as Lactobacillus rhamnose for 8 weeks. Placebo capsules are similar in appearance to probiotic capsules and to sachets, similar to inulin-containing sachets, and are difficult to distinguish. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared When: Accessibility to data is possible 8 months after publication. To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis Where to obtain: Dr Jalal Moludi, Faculty of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, +989399516760, jmoludi@yahoo.com How to obtain: Any one who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All these steps will not take more than 10 days. Comments:
public Dr. Jalal Moloudi
Faculty of Nutrition and Food Technology, Next to Farabi Hospital
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 jmoludi@yahoo.com Kermanshah University of Medical Sciences scientific Dr Jalal Moludi
Faculty of Nutrition and Food Technology, Next to Farabi Hospital
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 jmoludi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients with coronary artery stenosis body mass index is between 25-35 kg/m2 no limit no limit Both Heart failure or cardiac output less than 30% Supplement intolerance Patient decision to exclude study I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo 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 after lunch. Lactobacillus rhamnosus will provide 1.6× 10^10 colony forming units (CFU) bacterial drug capsules and the target group will consume one capsule daily. To ensure supplement consumption, patients will be contacted weekly. The Quality of Life Questionnaire (McNEW) and Depression Inventory (Beck) were also completed Intervention group: Patients in this group will receive pro-inulin supplement for 8 weeks. Inulin will be given in 10 grams of medicated sachets and the target group will consume once daily after lunch. In addition, a placebo capsule containing maltodextrin as a placebo for Lactobacillus rhamnosus will consume one post-meal daily. To ensure supplement consumption, patients will be contacted weekly. The Quality of Life Questionnaire (McNEW) and Depression Inventory (Beck) were also completed Intervention group: Patients in this group will receive probiotic supplements for 8 weeks. Lactobacillus rhamnosus will provide 1.6× 10^10 colony forming units (CFU) bacterial drug capsules and the target group will consume one capsule daily. In addition, they will consume a single dose of maltodextrin replacement inulin daily after lunch. To ensure supplement consumption, patients will be contacted weekly. The Quality of Life Questionnaire (McNEW) and Depression Inventory (Beck) were also completed Control group: Patients in this group receive an injection of maltodextrin daily with inulin and a placebo capsule containing maltodextrin as Lactobacillus rhamnose for 8 weeks. Placebo capsules are similar in appearance to probiotic capsules and to sachets, similar to inulin-containing sachets, and are difficult to distinguish. 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. Assessment of gut microbiota. Timepoint: At the baseline and after intervention. Method of measurement: Via real time PCR. Kermanshah University of Medical Sciences Approved 2020-02-04 Ethics Committee of Kermanshah University of Medical Sciences Faculty of Nutrition and Food Technology, Next to Farabi Hospital, Kermanshah, Iran , Postcode: 6719851552 Kermanshah Kermanshah Iran (Islamic Republic of)