The effect of functional food mixtures on serum levels of inflammatory cytokines and laboratory findings in patients with covid-19
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
The amount of inflammatory and anti-inflammatory cytokines ( Il-1β، Il-6، TNFα ، IL-10، IL-4 ، IFNƳ )
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038585N11
Registration date:2021-08-23, 1400/06/01
Registration timing:registered_while_recruiting
Last update:2021-08-23, 1400/06/01
Update count:1
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of functional food mixtures on serum levels of inflammatory cytokines and laboratory findings in patients with covid-19
Public title
Effect of functional food mixtures on serum levels of inflammatory cytokines in patients with covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Molla Sadra Ave., Vannak Sq
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.BMSU.REC.1399.149
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
The amount of inflammatory and anti-inflammatory cytokines (Il-1β، Il-6، TNFα،IL-10، IL-4 ,IFNƳ )
Timepoint
At the start and after 1 week of study
Method of measurement
Through intravenous blood samples and commercial kits
Secondary outcomes
1
Description
Laboratory findings
Timepoint
At the beginning and after 1 week of study
Method of measurement
Through intravenous blood samples and commercial kits
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
baqiyatallah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Street address
Sheykh bahaei Ave , Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5470
Fax
Email
parastouei@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Ali Shiri
Street address
sheykh bahaei Ave , Molasadra st
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
research@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Baqiyatallah University of Medical Sciences, sheikh bahaei Ave, Mollasadra st
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5470
Email
parastouei@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Baqiyatallah University of Medical Sciences, sheikh bahaei Ave, Mollasadra st
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5470
Email
parastouei@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yahya Jalilpiran
Position
Ph.D candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Baqiyatallah University of Medical Sciences, sheikh bahaei Ave, Mollasadra st
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5470
Email
Yjalilpiran@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available