Comparison of the effect of high and moderate intensity aerobic exercise with spirulina supplementation on ACE2 receptor sensitivity in obese people during SARS-COVID-2 epidemic
Comparison of training with different intensities with consumption in obese people in order to prevent Covid 19
Design
A randomized, double-blind, randomized controlled clinical trial on 60 healthy obese individuals. Excel software rand function was used for randomization.
Settings and conduct
Sports Medicine Center of Tehran University of Medical Sciences - Obesity Clinic of Shariati Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria are body mass index greater than 30 in people aged 40 to 50 years, no cardiovascular, skeletal, muscular and metabolic diseases limiting exercise, no hypertension and diabetes, no history Regular exercise during the last 6 months and not taking drugs and smoking. Contradiction of any of the above is a condition of non-inclusion in the study.
Intervention groups
1- High intensity aerobic exercise intervention group
2- Medium intensity aerobic exercise intervention group
3- Intervention group only taking spirulina supplement
4- High intensity aerobic exercise intervention group and spirulina consumption
5- Medium intensity aerobic exercise intervention group and spirulina consumption
6- Control group
Comparison of the effect of high and moderate intensity aerobic exercise with spirulina supplementation on ACE2 receptor sensitivity in obese people during SARS-COVID-2 epidemic
Public title
The effect of aerobic exercise with different intensities and spirulina supplementation on ACE2 expression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy obese people 40 to 50 years without mobility restrictions
Exclusion criteria:
Any type of disease including cardiovascular, diabetes, hypertension, thyroid and in general any type of acute and chronic diseases
Movement restrictions
Age
From 40 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study will be randomly classified. The number of samples is 72 (36 men and 36 women). Since the expression of the effect of Intervenors may be significantly different according to the sex of individuals, so in sampling we study an equal number of each sex. Also, considering that the age range of the samples in the study is between 40 and 50 years, in order to be able to make comparisons in age ranges, the categories include people aged 40 to 43 years, 44 to 47 years and 48 to 50 years in We do both groups of men and women. Based on this, we divide the sample space into 6 blocks of 12 people. Since in this study, one category belongs to the control group and five categories belong to the intervention group, so each block includes 2 members from each of these categories, which is placed in that category based on gender and age. The sealed envelop online software at https://www.sealedenvelope.com is used to randomize the sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the error caused by the knowledge of the participants and the researcher about the type of
treatment received and its possible effect on the research result, the study was conducted in two ways.
We do blind. The placebo and the spirulina supplement are placed inside the capsule in exactly the same way, which is no different, so the participants and the researcher are not aware of the type of supplement received.
Placebo
Used
Assignment
Factorial
Other design features
This study is designed based on the researcher's idea and its molecular cell pathway is invented by the researcher. Increased exercise-induced irisin increases the expression of the TRIB3 gene, and increased expression of this gene causes changes in the expression of ACE2 (the main receptor of Covid 19). Therefore, reducing the expression of ACE2 as the main receptor of Covid 19 can be effective in preventing Covid 19, especially in obese people. Because obese people naturally have an increase in ACE2 expression.
The univercity of Islamic Azad University of Research Sciences, Tehran
Full name of responsible person
Fariba Armannia
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Above Keshavarz Boulevard, Kabkanian Alley, Qazvini Alley, No. 9 Unit
City
Tehran
Province
Tehran
Postal code
1415733868
Phone
0098 21 814502
Email
phd.armannia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The univercity of Islamic Azad University, Research Sciences Branch
Full name of responsible person
Fariba Armannia
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Above Keshavarz Boulevard, Kabkanian Alley, Qazvini Alley, No. 9 Unit
City
Tehran
Province
Tehran
Postal code
1415733868
Phone
+98 21 8145 4502
Email
phd.armannia@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the general data of the participants such as demographic information such as age, sex, height, weight and body mass index after being unidentifiable will be shared in the results of the study.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for information about unrecognizable results and general data
From where data/document is obtainable
Refer to the researcher's email at phd.armannia@gmail.com
What processes are involved for a request to access data/document
It will be available via email no later than one day after the request