Protocol summary
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Study aim
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Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin 3, N-terminal prohormone of brain natriuretic peptide, Apo B100, oxidized low density lipoprotein, ADMA, lecithin Cholesterol acyl transferase activity, sCD163 to sTWEAK ration and urea nitrogen in patients with chronic heart failure
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Design
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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).This study is in the third phase of clinical trial
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Settings and conduct
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The present study will be carried out as a double-blind randomized clinical trial in patients with chronic heart failure who referred to the Shahid Rajaee Cardiology Center. No changes in physical activity or diet are expected during the study.
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Participants/Inclusion and exclusion criteria
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Criteria for entering the study: 1- Age range 30-70 years. 2. Having common symptoms of heart failure for at least 1 month.
3.Decreased LVEF (less than 40%). 4- Being in one of the NYHA classification steps 1-3
5- Desire to participate in the study and sign a written informed consent
Non-inclusion criteria:
1- Cases of other diseases and chronic and acute liver disorders, diabetes, thyroid disorders, severe renal dysfunction, pulmonary diseases, inflammatory diseases and Known autoimmune, cancer, rheumatoid arthritis, acute infection. 2- taking any nutritional supplement during the past month. 3- smoking and narcotic drugs consumption. 4- Intolerance to lactose and allergy to dairy products. 5- taking corticosteroid in the last 4 weeks
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Intervention groups
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1. Intervention group: receive 300 grams of probiotic yogurt per day for 10 weeks.
2. Control group :receive 300 grams of ordinary yogurt per day for 10 weeks.
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Main outcome variables
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Pentraxin 3 and oxLDL
General information
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Reason for update
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Adding a new factor (Urea nitrogen) and removing deleted factors (ApoA1 and PON1 activity and lipid profile)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091114002709N48
Registration date:
2018-03-12, 1396/12/21
Registration timing:
prospective
Last update:
2019-11-05, 1398/08/14
Update count:
2
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Registration date
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2018-03-12, 1396/12/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-04, 1397/01/15
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Expected recruitment end date
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2018-12-06, 1397/09/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Comparison of probiotic yogurt and ordinary yogurt consumption in patients with chronic heart failure.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 30 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-20, 1396/10/30
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Ethics committee reference number
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IR.IUMS.REC 1396.9511468002
Health conditions studied
1
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Description of health condition studied
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Chronic heart failure
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ICD-10 code
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I50.9
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ICD-10 code description
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Cardiac, heart or myocardial failure NOS
Primary outcomes
1
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Description
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Serum pentraxin3
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Timepoint
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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).
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Method of measurement
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ELISA kit
2
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Description
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Serum oxidized low density lipoprotein
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Timepoint
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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).
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Method of measurement
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ELISA kit
Secondary outcomes
1
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Description
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Serum N-terminal prohormone of brain natriuretic peptide
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Timepoint
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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).
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Method of measurement
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ELISA kit
2
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Description
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Serum Apolipoprotein B100
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Timepoint
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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).
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Method of measurement
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Immunoturbidimetry
3
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Description
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Serum Asymmetric dimethylarginine
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Timepoint
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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).
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Method of measurement
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ELISA kit
4
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Description
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Serum lecithin Cholesterol acyl transferase activity
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Timepoint
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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).
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Method of measurement
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ELISA kit
5
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Description
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sCD163 to sTWEAK ration
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Timepoint
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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).
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Method of measurement
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ELISA kit
6
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Description
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Serum urea nitrogen
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Timepoint
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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).
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Method of measurement
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Enzymatic colorimetric
Intervention groups
1
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Description
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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.
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Category
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Placebo
2
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Description
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Control group: Consumption of ordinary yogurt (300 gr/day for 10 weeks) that is prepared by Pak dairy factory.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only a part of the data will be shared, such as information about primary outcomes and Etc.
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When the data will become available and for how long
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The access period will be 6 months after publication of the results.
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To whom data/document is available
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The obtained data from current study will be available only for researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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