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IRCT20231225060520N1 IRCT 2024-01-23 Mashhad University of Medical Sciences The Effect of Diet with probiotic on Cardiovascular Function The Effect of Sustainable Diet Combined with Time-Restricted Eating and Probiotic Supplementation on Cardiovascular Function among Patients with Chronic Heart Failure with reduced Ejection Fraction (HFrEF): A Randomized Clinical Trial Study 2025-04-04 anticipated 75 Complete https://irct.ir/trial/74743 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use stratified blocked randomization for random allocation. Body mass index (BMI) is considered as a classifier variable. By using the site www.sealdenvelope.com and the classifier variable (BMI) and selecting blocks of 6 on the site, a random sequence will be generated. The mentioned sequences are placed in opaque, numbered and sealed envelopes or SNOSE by the research associate. Upon entering each patient, after obtaining informed consent and checking the inclusion and non-inclusion and exclusion criteria, the first envelope is opened and the patient is assigned to one of the 3 relevant groups. In the same way, the randomization process will continue until the last patient. In order to apply concealment allocation in the random allocation process, unique codes will be used on medicine containers. So that the desired code is also generated by the online website. As each person enters the study based on the generated sequence, the medicine container in which the desired code is recorded is assigned to the person and therefore, before choosing the person, no one is aware of the type of treatment he/ she will receive. Medicine containers are also non-transparent closed lids and capsules will be the same in terms of quantity, color, taste and smell, Blinding description: This study is not blinded in terms of diet but will be blinded in terms of supplements. The probiotic supplement and its placebo will be produced by PARSILACT Company. All probiotic and its placebo supplements will provided by PARSILACT Company in prepacked pharmaceutical polyethylene bottle numbered for each patient according to the randomization sequence. The probiotic supplement and its placebo will be in the same form package. The researcher and patients will not be aware of the pharmaceutical polyethylene bottle's content until the end of the trial. 3 Patients with Chronic Heart Failure with reduced Ejection Fraction (HFrEF). Intervention 1: First Intervention group: Dietary advices + Probiotic placebo (without Lactobacillus plantarum 299v, twice daily for 60 days). Intervention 2: Second Intervention group: ‌Sustainable diet combined with time-restricted eating + Probiotic placebo (without Lactobacillus plantarum 299v, twice daily for 60 days). Intervention 3: Third Intervention group: Sustainable diet combined with time-restricted eating + Probiotic Capsule (Lactobacillus plantarum 299v with a dose of 14 billion CFU, twice daily for 60 days). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Pegah Rahbarinejad
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
Mashhad Iran (Islamic Republic of) 9177948564 +98 21 8827 1524 pegah.rahbarinejad@gmail.com Mashhad University of Medical Sciences scientific Pegah Rahbarinejad
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
Mashhad Iran (Islamic Republic of) 9177948564 +98 21 8827 1524 pegah.rahbarinejad@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of heart failure with echocardiogram showing systolic dysfunction with ejection fraction ≤ 40% based on New York Heart Association (NYHA) class II-IIID heart failure symptoms with ischemic or non-ischemic etiology Under standard treatment with drugs Men and women with age range of 30-75 years Willingness to participate in the study and complete the informed consent form 30 years 75 years Both Use of nutritional supplements (oral or injectable, such as vitamins D, C, E, calcium, magnesium, potassium, multivitamin- mineral, omega 3) and herbal products with antioxidant and anti-inflammatory properties, probiotic or synbiotic supplements or products containing them during the study Not consuming more than 20% of the capsules Unwillingness to continue cooperation in research I50.9 Heart failure, unspecified Placebo Treatment - Other Treatment - Other First Intervention group: Dietary advices + Probiotic placebo (without Lactobacillus plantarum 299v, twice daily for 60 days) Second Intervention group: ‌Sustainable diet combined with time-restricted eating + Probiotic placebo (without Lactobacillus plantarum 299v, twice daily for 60 days) Third Intervention group: Sustainable diet combined with time-restricted eating + Probiotic Capsule (Lactobacillus plantarum 299v with a dose of 14 billion CFU, twice daily for 60 days) N Terminal pro Natriuretic Peptide type B (NT-proBNP). Timepoint: In the beginning of the study (before the start of the intervention) and 60 days after the intervention. Method of measurement: Kit for measuring N-terminal pro-natriuretic peptide type B in venous blood sample. Mashhad University of Medical Sciences Approved 2024-01-03 Ethics committee of Mashhad University of Medical Sciences Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Razavi Khorasan Mashhad Razavi Khorasan Iran (Islamic Republic of)