The effect of Moringa oral product on inflammatory factors, insulin resistance and abdominal obesity in military with metabolic syndrome, clinical trial
General objective: To determine the effect of Moringa oral product consumption on inflammatory factors and insulin resistance and abdominal obesity in soldiers with metabolic syndrome.
Application goal: using the results of this plan to improve disease and inflammation in soldiers suffering from metabolic syndrome
Design
A controlled, double-blind, randomized, phase 3 clinical trial on 102 patients. Blocks of 4 are used for randomization.
Settings and conduct
In order to carry out this research in a double-blind manner, before starting the study, the cans containing the respective pills are coded as A and B by someone other than the researcher, so that the researcher does not know the type of pill received by each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Completing the consent form and interest in participating in the study; Waist circumference higher than 80 cm in women and higher than 94 cm in men (main IDF criteria); Having criteria for metabolic syndrome (according to the International Diabetes Federation)
Non-entry criteria:
Unwillingness to continue studying at any stage of project implementation; Trying to get pregnant; Diagnosing of the disease or starting drug treatment;
Incidence of intolerance to moringa food products.
Intervention groups
Determining the dose of the drug based on the extraction of moringa extract will be determined in the process of doing the work (2 grams) and the duration of the intervention will be 8 weeks based on the available evidence.
Control group (placebo): a syrup that is similar in color and smell to the syrup of the intervention group, but does not contain the main drug, for 8 weeks.
The effect of Moringa oral product on inflammatory factors, insulin resistance and abdominal obesity in military with metabolic syndrome, clinical trial
Public title
Effect of Moringa in metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60 years old - no specific underlying disease (such as malignancy, kidney and liver failure) - no pregnancy or breastfeeding - no allergy to moringa food product - no smoking and alcohol consumption -Completion of the consent form and interest in participating in the study - Waist circumference above 80 cm in women and above 94 cm in men (the main criterion of IDF) - Having the criteria of metabolic syndrome (according to the International Diabetes Federation)
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The type of randomization will be block type. Classification of people based on the age of 18 to 40 and 40 to 60 years, gender (male/female) and BMI (25 to 30 and 30 to 40) has been done using blocks of four (In order to distribute confounders equally in two groups at each time point of the study). Identification codes of patients in the randomized list will be obtained through the site related to random blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to carry out this research in a double-blind manner, before starting the study, the cans containing the respective pills are coded as A and B by someone other than the researcher, so that the researcher does not know the type of pill received by each group. In addition, the patient himself does not know about the contents of the syrup.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی ارتش جمهوری اسلامی ایران (کمیته اخلاق در پژوهش)
Street address
Shahid Etemadzadeh St, West Fatemi St, Tehran
City
Tehran
Province
Tehran
Postal code
021-86096350-5
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.AJAUMS.REC.1402.058
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
66
ICD-10 code description
E-66
Primary outcomes
1
Description
Tumor necrosis factor-alpha
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
2
Description
High sensitive C reactive protein
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
3
Description
Erythrocyte sedimentation rate
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
4
Description
Interleukin 6
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
5
Description
Malondialdehyde
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
6
Description
Insulin
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
7
Description
Glycated Hemoglobin
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
8
Description
Homeostatic Model Assessment for Insulin Resistance
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Blood sample
9
Description
Body fat percentage
Timepoint
At the beginning of the study and 8 weeks after starting the Moringa supplement
Method of measurement
Body analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Military patients with metabolic syndrome taking 2 grams of Moringa supplement daily for 8 weeks.
Category
Prevention
2
Description
Control group: Military patients with metabolic syndrome taking 2 grams of placebo daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان 550 ارتش
Full name of responsible person
Mohammad rashidmayvan
Street address
Bahar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91746 75155
Phone
+98 51 3859 1052
Email
Army@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Vahid Hadi
Street address
Shahid Etemadzadeh Street, Fatemi West Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Mail@ajams.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Rashidmayvan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bahar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9146997555
Phone
+98 51 3854 2140
Email
Rashidmayvan.m@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Rashidmayvan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bahar ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9146997555
Phone
+98 51 3859 1052
Email
Rashidmayvan.m@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Rashidmayvan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bahar ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9146997555
Phone
+98 51 3859 1052
Email
Rashidmayvan70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The protocol article will be published after obtaining the clinical trial code and the intervention article after the completion of the study.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Supervisors and adviser
Under which criteria data/document could be used
In order to request journals for the validity of the study and to follow up the study
From where data/document is obtainable
Mohammad Rashidmayvan
Vahid Hadi
What processes are involved for a request to access data/document
After the official request in writing or by email, it will be sent within 2 weeks.