The effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
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Protocol summary
Determine the effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
Determining the effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
DetermineDetermining the effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
Anthropometric indices ( weight, waist circumference, hip circumference), glycemic indices( fasting blood sugar, fasting insulin, HOMA-IR), lipid profile and blood pressure.
weight, waist circumference, hip circumference, fasting blood sugar, fasting insulin, HOMA-IR, lipid profile, HDL2-c, HDL3-c, HDL2-c/HDL3-c, and blood pressure.
Anthropometric indices ( weight, waist circumference, hip circumference), glycemic indices( fasting blood sugar, fasting insulin, HOMA-IR), lipid profile, HDL2-c, HDL3-c, HDL2-c/HDL3-c, and blood pressure.
شاخص های آنتروپومتریک ( وزن، دورکمر و دروباسن) و شاخص های گلایسمیک( قند خون ناشتا، انسولین ناشتا ، HOMA-IR )، پروفایل لیپیدی و فشار خون می باشد.
وزن، دورکمر، دور باسن، قند خون ناشتا، انسولین ناشتا ، HOMA-IR،
پروفایل لیپیدی ،HDL2-c/HDL3-c، HDL3-c، HDL2-c و فشار خون .
شاخص های آنتروپومتریک ( وزن، دورکمر و دروباسن) و شاخص های گلایسمیک(، دور باسن، قند خون ناشتا، انسولین ناشتا ، HOMA-IR )، پروفایل لیپیدی ،HDL2-c/HDL3-c، HDL3-c، HDL2-c و فشار خون می باشد.
General information
empty
Considering the association of HDL-c subclasses (HDL2-c, HDL3-c and HDL2-c/HDL3-c) with metabolic syndrome and cardiovascular diseases (CVD), assessing these variables can provide a more precise result on the effect of theobromine on CVD risk factors. Additionally, HDL-c function can be determined via assessing these factors. Therefore, we aim to include these variables in our study.
Considering the association of HDL-c subclasses (HDL2-c, HDL3-c and HDL2-c/HDL3-c) with metabolic syndrome and cardiovascular diseases (CVD), assessing these variables can provide a more precise result on the effect of theobromine on CVD risk factors. Additionally, HDL-c function can be determined via assessing these factors. Therefore, we aim to include these variables in our study.
empty
با توجه به ارتباط زیرگروه های HDL-c (HDL2-c، HDL3-c و HDL2-c/HDL3-c) با سندرم متابولیک و بیماری های قلبی عروقی، ارزیابی این متغیرها می تواند نتیجه بسیار دقیق تری در مورد تأثیر تئوبرومین بر عوامل خطر بیماری های قلبی-عروقی به ما بدهد. علاوه بر این، عملکرد HDL-c را می توان از طریق ارزیابی این عوامل تعیین کرد. بنابراین، هدف ما گنجاندن این متغیرها در مطالعه است.
با توجه به ارتباط زیرگروه های HDL-c (HDL2-c، HDL3-c و HDL2-c/HDL3-c) با سندرم متابولیک و بیماری های قلبی عروقی، ارزیابی این متغیرها می تواند نتیجه بسیار دقیق تری در مورد تأثیر تئوبرومین بر عوامل خطر بیماری های قلبی-عروقی به ما بدهد. علاوه بر این، عملکرد HDL-c را می توان از طریق ارزیابی این عوامل تعیین کرد. بنابراین، هدف ما گنجاندن این متغیرها در مطالعه است.
Researchers, participants and data analyzer will be blinded in this study. so that the patient does not know which treatment group he or she belongs to, because both the placebo and supplement groups are prepared in exactly the same form and package. By following a random list containing codes 1 to 80, The researchers also do not know which treatment group was assigned to each patient. Because the random list will be prepared by the project executive expert (Personal except researcher and data analyst) and only the patient code will be recorded on each drug package. Thus, none of the participants, researchers and data analysts of the study type They do not know the dedicated treatment and the study will be triple-blind.
Researchers, participants and data analyzer will be blinded in this study. so that the patient does not know which treatment group he or she belongs to, because both the placebo and supplement groups are prepared in exactly the same form and package. By following a random list containing codes 1 to 80, The researchers also do not know which treatment group was assigned to each patient. Because the random list will be prepared by the project executive expert (Personal except researcher and data analyst) and only the patient code will be recorded on each drug package. Thus, none of the participants, researchers and data analysts of the study type They do not know the dedicated treatment and the study will be triple-blind.
Researchers, participants and data analyzer will be blinded in this study. so that the patient does not know which treatment group he or she belongs to, because both the placebo and supplement groups are prepared in exactly the same form and package. By following a random list containing codes 1 to 80, The researchers also do not know which treatment group was assigned to each patient. Because the random list will be prepared by the project executive expert (Personal except researcher and data analyst) and only the patient code will be recorded on each drug package. Thus, none of the participants, researchers and data analysts of the study type They do not know the dedicated treatment and the study will be triple-blind.
Primary outcomes
#1
empty
HDL2-C Subclass
HDL2-C Subclass
empty
زیرگروه 2 لیپویروتئین با چگالی بالا (HDL-c)
زیرگروه 2 لیپویروتئین با چگالی بالا (HDL-c)
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
empty
ابتدای مطالعه و در پایان هفته ۱۲
ابتدای مطالعه و در پایان هفته ۱۲
empty
ELISA (enzyme-linked immunosorbent assay)
ELISA (enzyme-linked immunosorbent assay)
empty
الایزا (آزمایش ایمونوسوربنت همراه با آنزیم)
الایزا (آزمایش ایمونوسوربنت همراه با آنزیم)
#2
empty
HDL3-C Subclass
HDL3-C Subclass
empty
زیرگروه 3 لیپویروتئین با چگالی بالا (HDL-c)
زیرگروه 3 لیپویروتئین با چگالی بالا (HDL-c)
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
empty
ابتدای مطالعه و در پایان هفته ۱۲
ابتدای مطالعه و در پایان هفته ۱۲
empty
ELISA (enzyme-linked immunosorbent assay)
ELISA (enzyme-linked immunosorbent assay)
empty
الایزا (آزمایش ایمونوسوربنت همراه با آنزیم)
الایزا (آزمایش ایمونوسوربنت همراه با آنزیم)
#3
empty
HDL2-C/HDL3-C
HDL2-C/HDL3-C
empty
نسبت HDL2-C به HDL3-C
نسبت HDL2-C به HDL3-C
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
empty
ابتدای مطالعه و در پایان هفته ۱۲
ابتدای مطالعه و در پایان هفته ۱۲
empty
Dividing HDL2-C to HDL3-C values
Dividing HDL2-C to HDL3-C values
empty
تقسیم مقادیر HDL2-C به HDL3-C
تقسیم مقادیر HDL2-C به HDL3-C
Recruitment centers
#1
Name of recruitment center - English: همه مراکز بهداشتی وابسته به دانشگاه علوم پزشکی کرمانشاه
Name of recruitment center - Persian: All health centers affiliated to Kermanshah University of Medical Sciences
Full name of responsible person - English: Ebrahim Shakiba
Full name of responsible person - Persian: ابراهیم شکیبا
Street address - English: Bahar street, healyh deputy of kermanshah universiyu of medical sciences
Street address - Persian: خیابان بهار، معانت بهداشتی دانشگاه علوم پزشکی کرمانشاه
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6719954518
Phone: +98 83 3725 7799
Fax:
Email: mbok@kums.ac.ir
Web page address:
Name of recruitment center - English: All health centers affiliated to Kermanshah University of Medical Sciences
Name of recruitment center - Persian: همه مراکز بهداشتی وابسته به دانشگاه علوم پزشکی کرمانشاه
Full name of responsible person - English: Ebrahim Shakiba
Full name of responsible person - Persian: ابراهیم شکیبا
Street address - English: Bahar street, healyh deputy of kermanshah universiyu of medical sciences
Street address - Persian: خیابان بهار، معانت بهداشتی دانشگاه علوم پزشکی کرمانشاه
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6719954518
Phone: +98 83 3725 7799
Fax:
Email: mbok@kums.ac.ir
Web page address:
Name of recruitment center - English: همه مراکز بهداشتی وابسته به دانشگاه علوم پزشکی کرمانشاه Name of recruitment center - Persian: All health centers affiliated to Kermanshah University of Medical Sciences Name of recruitment center - Persian: همه مراکز بهداشتی وابسته به دانشگاه علوم پزشکی کرمانشاه Full name of responsible person - English: Ebrahim Shakiba Full name of responsible person - Persian: ابراهیم شکیبا Street address - English: Bahar street, healyh deputy of kermanshah universiyu of medical sciences Street address - Persian: خیابان بهار، معانت بهداشتی دانشگاه علوم پزشکی کرمانشاه City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6719954518 Phone: +98 83 3725 7799 Fax: Email: mbok@kums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sayyed Abbas Motevallian, deputy head of Research and technology, Iran university of medical sci
Full name of responsible person - Persian: سید عباس متولیان، معاون تحقیقات و فناوری، دانشگاه علوم پزشکی ایران
Street address - English: Hemmat Highway, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2504
Fax:
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hossein Keyvani, deputy head of Research and technology, Iran university of medical sci
Full name of responsible person - Persian: حسین کیوانی، معاون تحقیقات و فناوری، دانشگاه علوم پزشکی ایران
Street address - English: Hemmat Highway, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2504
Fax:
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Sayyed Abbas MotevallianHossein Keyvani, deputy head of Research and technology, Iran university of medical sci Full name of responsible person - Persian: سید عباس متولیانحسین کیوانی، معاون تحقیقات و فناوری، دانشگاه علوم پزشکی ایران Street address - English: Hemmat Highway, Iran University of Medical Sciences Street address - Persian: بزرگراه همت، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8670 2504 Fax: Email: research-m@iums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
Design
A 12-week triple-blid, randomized parallel clinical trial on 80 overweight and obese subjects with metabolic syndrome
Settings and conduct
After the approval of the proposal study subjects were selected from those who refer to the health centers affiliated to Kermanshah University of Medical Sciences. Eligible individuals will be interviewed and the goals, methods and importance of conducting the study will be explained in detail to each of them After providing written consent, they will be divided into 2 groups of Theobromine and placebo by Stratified Blocked Randomization. Subjects will be asked to take a 450 mg / day theobromine capsule for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight or subjects aged 40 to 55 years with metabolic syndrome.
Exclusion criteria: having Diabetes, cancer, hepatitis, cardiovascular disease, hematological, neurological, renal, thyroid and gastrointestinal disorders. Consumption of medications or supplements that affect appetite, weight or metabolism, and having any weight loss diet or heavy exercise program in the past 6 months. Patients treated with statins and antihypertensive drugs will only be included in the study if they are treated for more than 3 months for statins and more than 6 months for high blood pressure.
Intervention groups
Intervention group: 450 mg/d theobromine capsule in breakfast meal for 12 weeks.
Control group: 450 mg/d placebo capsule in breakfast meal for 12 weeks.
Main outcome variables
weight, waist circumference, hip circumference, fasting blood sugar, fasting insulin, HOMA-IR, lipid profile, HDL2-c, HDL3-c, HDL2-c/HDL3-c, and blood pressure.
General information
Reason for update
Considering the association of HDL-c subclasses (HDL2-c, HDL3-c and HDL2-c/HDL3-c) with metabolic syndrome and cardiovascular diseases (CVD), assessing these variables can provide a more precise result on the effect of theobromine on CVD risk factors. Additionally, HDL-c function can be determined via assessing these factors. Therefore, we aim to include these variables in our study.
Acronym
IRCT registration information
IRCT registration number:IRCT20091114002709N59
Registration date:2022-03-05, 1400/12/14
Registration timing:registered_while_recruiting
Last update:2023-12-12, 1402/09/21
Update count:1
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-19, 1400/10/29
Expected recruitment end date
2022-05-19, 1401/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
Public title
The effect of Theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight or obese (25 ≤BMI≤ 35 kg/m^2) men and women aged 40 to 55 years .
Having metabolic syndrome according to IDF definition ( Waist circumference greater than 94 cm for men and 80 cm for women, Triglyceride ≥ 150mg/dl, HDL-c ≤ 40mg/dl for men and HDL-c ≤ 50mg/dl for women or medication, Systolic blood pressure ≥ 130mmHg and DBP≥ 85 mmHg or medication, Fasting blood sugar≥ 100mg/dl or medication)
Tendency to participate in the study
Exclusion criteria:
Smoking
Subjects with diabetes, cancer, hepatitis, cardiovascular diseases, hematological disorders, Neurological disorders, renal disorders, gastrointestinal and thyroid disorders
Insulin therapy, use hypoglycemic and weight reduction medication, vasodilators, hormone therapy, corticosteroids, non steroid anti inflammatory drugs, antihistamines, Selective serotonin reuptake inhibitors, anti gout and psychotics medication.
Use of any vitamin and mineral supplement, antioxidants and omega3.
Pregnancy, lactation and adherence to a specific diet
People treated with statins and antihypertensive drugs will only be included in the study if they are treated for more than 3 months for statins and more than 6 months for high blood pressure.
Age
From 40 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by Stratified Blocked Randomization with the volume 4. Stratification will be done based on participants BMI (25-30 and 30-35). Considering the sample size of 40 in each strata, 10 blocks with volume 4 will be produced in each strata and subjects in each strata will be assigned to treatment or placebo group based on a random list produced by PASS 11 statistical software . The random list containing 3-digit codes for each patient that identifies the relevant treatment will be provided to the researcher and will be inserted on the labels of 80 drug bottles. Only the study project executive expert is aware of the designed codes. Randomization and blinding of the study are performed to maintain concealment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researchers, participants and data analyzer will be blinded in this study. so that the patient does not know which treatment group he or she belongs to, because both the placebo and supplement groups are prepared in exactly the same form and package. By following a random list containing codes 1 to 80, The researchers also do not know which treatment group was assigned to each patient. Because the random list will be prepared by the project executive expert (Personal except researcher and data analyst) and only the patient code will be recorded on each drug package. Thus, none of the participants, researchers and data analysts of the study type They do not know the dedicated treatment and the study will be triple-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-11-20, 1400/08/29
Ethics committee reference number
IR.IUMS.REC.1400.761
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weight
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Seca scale
2
Description
Body mass index(BMI)
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Weight (kg) divided by height squared (square meters)
3
Description
Waist circumference
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Measuring tape
4
Description
Hip circumference
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Measuring tape
5
Description
Systolic blood pressure
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Sphygmomanometer
6
Description
Triglyceride
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Colorimetri
7
Description
Total cholesterol
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Colorimetri
8
Description
LDL-c
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Colorimetri
9
Description
HDL-c
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Colorimetri
10
Description
Fasting insulin
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
ELIZA kit
11
Description
Fasting blood sugar
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Enzymatic
12
Description
HDL2-C Subclass
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
ELISA (enzyme-linked immunosorbent assay)
13
Description
HDL3-C Subclass
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
ELISA (enzyme-linked immunosorbent assay)
14
Description
HDL2-C/HDL3-C
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Dividing HDL2-C to HDL3-C values
Secondary outcomes
1
Description
Sirtuin 1 gene expression
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Real Time PCR
2
Description
PPARα gene expression
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
Real Time PCR
Intervention groups
1
Description
Intervention group: Daily intake of a 450 mg theobromine capsule (made by BulkSupplement company; USA) in breakfast meal for 12 weeks.
Category
Treatment - Other
2
Description
Control group: Daily intake of a 450 mg maltodextrin capsule (made by Karen Pharmaceuticals and Dietary Supplements Company; Iran) in breakfast meal for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
All health centers affiliated to Kermanshah University of Medical Sciences
Full name of responsible person
Ebrahim Shakiba
Street address
Bahar street, healyh deputy of kermanshah universiyu of medical sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719954518
Phone
+98 83 3725 7799
Email
mbok@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani, deputy head of Research and technology, Iran university of medical sci
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14496145535
Phone
+98 21 8860 7945
Email
farzadshidfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Email
shidfar.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Email
shidfar.f@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
اطلاعات بیشتری وجود ندارد
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
Information on the main implications can be shared at the end of the study.
When the data will become available and for how long
The access period will be 6 months after the results are published.
To whom data/document is available
The data from this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers.
From where data/document is obtainable
Applicants can contact the responsible author via email or the following mailing address to obtain the required data. Postal address: Tehran-Hemmat Highway-Iran University of Medical Sciences-Faculty of Health-Department of Nutrition. Contact number: 00982188622755. Email: shidfar.f@iums.ac.ir
What processes are involved for a request to access data/document
Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week.