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IRCT20091114002709N48 IRCT 2018-03-12 Iran University of Medical Sciences Comparison of probiotic yogurt and ordinary yogurt consumption in patients with chronic heart failure. Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3، NT-proBNP، ApoB100، oxLDL، ADMA، LCAT activity، sCD163 to sTWEAK ration and Urea nitrogen in patients with chronic heart failure 2018-04-04 anticipated 90 Complete https://irct.ir/trial/29708 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. According to the sample size of 90 , 23 blocks will be produced using the online site (www.sealedenvelope.com), Blinding description: In order to apply concealment in the randomization process, unique codes will be used on yogurt containers, the code being generated by the software. By entering each individual into a study based on the produced sequence , the yogurt container in which the code is registered will be assigned to the individual.During the research, the random list is provided to the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups. 3 Chronic heart failure. Intervention 1: Intervention group: Consumption of Probiotic yogurt (300 gr/day for 10 weeks). Probiotic yogurt is prepared in the form of low-fat yogurt (1.5% fat) containing 10⁹ cfu /gr of Lactobacillus acidophilus La5 and lactobacillus bifidobacterium Bb12 by Pak dairy factory. Intervention 2: Control group: Consumption of ordinary yogurt (300 gr/day for 10 weeks) that is prepared by Pak dairy factory. Yes - There is a plan to make this available What will be shared: Only a part of the data will be shared, such as information about primary outcomes and Etc. When: The access period will be 6 months after publication of the results. To whom: The obtained data from current study will be available only for researchers working in academic and scientific institutions. Conditions: Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis. Where to obtain: Applicants can be contacted with correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition department, School of health, Iran University of Medical Sciences, Hemmat expressway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author, after a maximum of one week. Comments:
public Dr.Farzad Shidfar
School of health, Iran university of medical science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Dr.Farzad Shidfar
School of health, Iran university of medical science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age range 30 to 70 years Having common symptoms of heart failure for at least 1 month decreased LVEF (≤40%) Being in one of the NYHA classification steps 1-3 Desire to participate in the study and sign a written informed consent 30 years 70 years Both suffering or having chronic and acute liver (hepatitis B, C, etc.) Diseases and other, diabetes, thyroid disorders, severe renal dysfunction (creatinine more than 300 millimol/liter), pulmonary disease, known inflammatory and autoimmune diseases, Cancer, Rheumatoid Arthritis, Acute Infection taking any nutritional supplement during the past month smoking and using narcotic drugs Lactose intolerance and allergy to dairy products taking Corticosteroid drug in the last 4 weeks taking antibiotics over the past 3 months History of Gastrointestinal Surgery Taking anti-inflammatory drugs other than low dose of aspirin (one per day) Having an artificial heart valve History of rheumatic heart disease Pregnancy and lactation taking insulin body mass index more than 30 Kilogram/meter² I50.9 Cardiac, heart or myocardial failure NOS Placebo Placebo Intervention group: Consumption of Probiotic yogurt (300 gr/day for 10 weeks). Probiotic yogurt is prepared in the form of low-fat yogurt (1.5% fat) containing 10⁹ cfu /gr of Lactobacillus acidophilus La5 and lactobacillus bifidobacterium Bb12 by Pak dairy factory. Control group: Consumption of ordinary yogurt (300 gr/day for 10 weeks) that is prepared by Pak dairy factory. Serum pentraxin3. Timepoint: Measurement of serum pentraxin3 at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: ELISA kit. Serum oxidized low density lipoprotein. Timepoint: Measurement of serum oxidized low density lipoprotein at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: ELISA kit. Serum N-terminal prohormone of brain natriuretic peptide. Timepoint: Measurement of Serum N-terminal prohormone of brain natriuretic peptide at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: ELISA kit. Serum Apolipoprotein B100. Timepoint: Measurement of Serum Apolipoprotein B100 at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: Immunoturbidimetry. Serum Asymmetric dimethylarginine. Timepoint: Measurement of Serum Asymmetric dimethylarginine at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: ELISA kit. Serum lecithin Cholesterol acyl transferase activity. Timepoint: Measurement of Serum lecithin Cholesterol acyl transferase activity at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: ELISA kit. SCD163 to sTWEAK ration. Timepoint: Measurement of Serum sCD163 to sTWEAK ration at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: ELISA kit. Serum urea nitrogen. Timepoint: Measurement of Serum urea nitrogen at the beginning of the study (before the intervention) and the end of the study (10 weeks after starting probiotic yogurt consumption). Method of measurement: Enzymatic colorimetric. Iran University of Medical Sciences Approved 2018-01-20 Ethics committee of Iran University of Medical Sciences Hemat Express way, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)