Protocol summary
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Study aim
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The effect of functional food mixtures on serum levels of inflammatory cytokines and laboratory findings in patients with covid-19
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Design
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Two-blind randomized clinical trial with parallel groups with a sample size of 30 people in each group Random number table was used for randomization.
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Settings and conduct
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The study will be performed on 60 patients with metabolic syndrome referred to Baqiyatallah Al-Azam Hospital who will be randomly assigned to the intervention and control groups. Patients in the intervention and placebo groups will receive 30 grams of healthy food or 30 grams of regular food (barley soup) after meals for 1 week daily. The researcher and participants will be blind to randomization and assignments until the end of the study.
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Participants/Inclusion and exclusion criteria
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Among the patients referred to Baqiyatallah Al-Azam Hospital, they will be diagnosed with Covid-19 by doctors according to international standards. Among people with Covid-19 who agree to participate in the study (age 20-70) will enter the study. People on special diets or HIV patients Cancer patients undergoing chemotherapy Immunized patients Patients in need of hospitalization in the intensive care unit of patients with uncontrolled heart, kidney or Liver of pregnant or lactating women
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Intervention groups
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Patients in the intervention group will receive 30 grams of functional food daily in the morning for 1 week. Control group: Patients in the control group will receive 30 grams of plain barley soup daily for 1 week as a placebo at the same time and as a snack.
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Main outcome variables
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The amount of inflammatory and anti-inflammatory cytokines ( Il-1β، Il-6، TNFα ، IL-10، IL-4 ، IFNƳ )
General information
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Reason for update
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Completion of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180201038585N11
Registration date:
2021-08-23, 1400/06/01
Registration timing:
prospective
Last update:
2022-11-05, 1401/08/14
Update count:
1
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Registration date
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2021-08-23, 1400/06/01
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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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2021-09-05, 1400/06/14
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Expected recruitment end date
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2022-01-04, 1400/10/14
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Actual recruitment start date
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2021-09-20, 1400/06/29
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Actual recruitment end date
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2022-01-14, 1400/10/24
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Trial completion date
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2022-05-09, 1401/02/19
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Scientific title
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Effect of functional food mixtures on serum levels of inflammatory cytokines and laboratory findings in patients with covid-19
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Public title
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Effect of functional food mixtures on serum levels of inflammatory cytokines in patients with covid-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The need for hospitalization with clinical signs in favor of coronavirus infection includes one or more of the following : The patient experiences a decrease in oxygen saturation of less than 93%
A drop in systolic blood pressure less than 100 or a drop in blood pressure of 30 mm Hg from the patient's previous normal systolic pressure
fever
Dry cough
the positive result of CRP index
Laboratory indexes included : CRP , ESR
Exclusion criteria:
Patient dissatisfaction
Lack of proper conditions for oral feeding
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Age
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From 20 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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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed using groups of 4 (blocks) that were similar in terms of sex and age by a random number table and trained by a third person and assigned to intervention and control groups to receive one of the treatments. Concealment was also performed using sealed envelopes so that researchers and participants were unaware of the allocation.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For blinding, regular food and functional food will be placed in the same 30 grams sachets. The sachets are then placed in paper boxes and will receive a special code from the label company. Ordinary and functional food codes will remain with the company until the end of the study to blind researchers, laboratory staff, and patients.
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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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2021-05-10, 1400/02/20
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Ethics committee reference number
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IR.BMSU.REC.1399.149
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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The amount of inflammatory and anti-inflammatory cytokines (Il-1β، Il-6، TNFα،IL-10، IL-4 ,IFNƳ )
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Timepoint
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At the start and after 1 week of study
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Method of measurement
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Through intravenous blood samples and commercial kits
Secondary outcomes
1
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Description
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Laboratory findings
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Timepoint
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At the beginning and after 1 week of study
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Method of measurement
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Through intravenous blood samples and commercial kits
Intervention groups
1
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Description
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Intervention group: At the beginning of the study, patients in the intervention group will receive 30-gram sachets of functional food (functional soup). Patients in the intervention group will be asked to consume a 30-gram packet of functional food (functional soup) daily in the morning for 1 week. In order to increase compliance, patients were asked on a daily basis.
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Category
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Treatment - Other
2
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Description
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Control group: Patients in the control group will receive 30-gram packages of regular food (barley soup) at the beginning of the study. Patients in the control group will be asked to consume a 30-gram packet of regular food (barley soup) daily in the morning for 1 week. In order to increase compliance, patients are asked on a daily basis.
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Category
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Treatment - Other
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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Bagheiat-allah 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available