The comparison of the effectiveness of replacing animal-based proteins with plant-based proteins on adropin levels, atherogenic index of plasma, and metabolic syndrome components in subjects with metabolic syndrome.
Determining and comparing of the effectiveness of replacing animal-based proteins with plant-based proteins on adropin levels, atherogenic index of plasma, and metabolic syndrome components in subjects with metabolic syndrome
Design
A randomized parallel clinical trial with a control group on 66 people with metabolic syndrome.
A valid site for creating random numbers (https://www.se aledenvelope.com/simple-randomiser/v1/lists) will be used for randomization.
Settings and conduct
Sixty-six people with metabolic syndrome will enter a randomized clinical trial after meeting the inclusion criteria. Participants will then be placed in one of two diet groups using balanced (permuted) block randomization method. The duration of the intervention will be 10 weeks. The first group will receive a diet containing 70% animal protein and 30% plant protein and the second group will receive a diet containing 30% animal protein and 70% plant protein. The percentage of macronutrients in both groups is considered the same.
Participants/Inclusion and exclusion criteria
Teachers aged 20 to 55 years old working in Isfahan with metabolic syndrome. Desire to participate in the study. Body mass index between 25 to 35 kg/m2. Lack of special diet for the past 6 months. Do not use dietary supplements. No history of kidney, liver, cardiovascular, thyroid or cancer diseases. Do not use hormonal drugs, birth control pills, glucocorticoids and drugs to lower blood sugar, blood pressure and lipids. Lack of pregnancy and lactation. No alcohol, cigarettes and tobacco.
Intervention groups
Control group: animal-based protein diet (containing 70% animal protein and 30% plant protein). Intervention group: plant-based protein diet (containing 30% animal protein and 70% plant protein).
Main outcome variables
Adropin; atherogenic index of plasma; metabolic syndrome components
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150909023957N10
Registration date:2022-05-16, 1401/02/26
Registration timing:prospective
Last update:2022-05-16, 1401/02/26
Update count:0
Registration date
2022-05-16, 1401/02/26
Registrant information
Name
Sayyed Morteza Safavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3168
Email address
safavimorteza@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of replacing animal-based proteins with plant-based proteins on adropin levels, atherogenic index of plasma, and metabolic syndrome components in subjects with metabolic syndrome.
Public title
The effect of replacing animal-based proteins with plant-based proteins on metabolic syndrome treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to participate in the study
Male and female teachers working in Isfahan
Age 20 to 55 years and Iranian nationality
Diagnosis of metabolic syndrome based on JIS criteria
Body mass index between 25 to 35 kg/m2
Exclusion criteria:
Follow a special diet for the past 6 months
Dietary supplements use
History of kidney, liver, cardiovascular, thyroid and cancer diseases
Use of hormonal drugs, birth control pills, glucocorticoids and drugs to lower blood sugar, blood pressure and lipids
Pregnancy and lactation
Alcohol, cigarettes and tobacco use
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be placed in one of two diet groups using balanced (permuted) block randomization method and using a valid site (https://www.se aledenvelope.com/simple-randomiser/v1/lists)for creating random numbers using quadratic blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Hezar jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.370
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Adropin
Timepoint
Initiation and end of the study (after 10 weeks)
Method of measurement
ELISA
2
Description
The atherogenic index of plasma (AIP)
Timepoint
Initiation and end of the study (after 10 weeks)
Method of measurement
Log (TG/HDL_C)
3
Description
Component of metabolic syndrome including fasting blood sugar, lipid profile, waist circumference, and blood pressure
Timepoint
Initiation and end of the study (after 10 weeks)
Method of measurement
Fasting blood sugar and lipid profile by enzymatic method and auto-analyzer, waist circumference using tape measure and blood pressure using Omron Upper arm Blood Pressure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Plant-based protein diet (diet containing 30% animal protein and 70% plant protein)
Category
Treatment - Other
2
Description
Control group: Animal-based protein diet (diet containing 70% animal protein and 30% plant protein)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools of Isfahan
Full name of responsible person
sayyed Morteza Safavi
Street address
Hezar jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 269 8847
Email
safavimorteza@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor in Research Affairs -Medical University of Isfahan
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hezar jrib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor in Research Affairs -Medical University of Isfahan
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
Esfahan University of Medical Sciences
Full name of responsible person
Sayyed Morteza Safavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3168
Email
safavimorteza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayyed Morteza Safavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Is
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3168
Fax
+98 31 3873 1866
Email
safavimorteza@nutr.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Shahdadian
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hezar jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 269 8847
Email
fshahdadian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
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
Title and more details about the data/document
Data of the main outcomes along with the method and materials and analysis as well as the informed consent can be shared after the hiding individuals.
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
Research centers and Vice-Chancellor in Research Affairs
Under which criteria data/document could be used
research use
From where data/document is obtainable
Dr. Sayyed Morteza Safavi
What processes are involved for a request to access data/document
Letter from the Vice-Chancellor in Research Affairs and the Ethics Committee