Investigating the functioning of the autonomic nervous system in different moods and diets
Design
A non-randomized clinical trial in the population of healthy people who are divided into two hot and cold temperament groups by completing a questionnaire and determining temperament.
Settings and conduct
It will be done in the Chamran Heart Center of Isfahan, and people will be subjected to Holter monitoring first, and the variables of heart rate variability index, blood pressure and body temperature will be measured. People receive a diet according to their temperament for three days, and then the above-measured indices are again given, after which they receive a normal diet for 3 days. And finally, for three days, they will receive a diet against their temperament.
Participants/Inclusion and exclusion criteria
Having physical and mental health based on history and initial examinations
Intervention groups
The intervention of this diet plan is cold and hot in nature.
Main outcome variables
Heart Rate Variability (HRV);
Mean Body Temperature;
Heart Rate;
Systolic and Diastolic Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200428047232N2
Registration date:2023-07-29, 1402/05/07
Registration timing:prospective
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Samane Pourajam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3332 2986
Email address
s_pourajam@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of dietary interventions on cardiovascular indexes among individuals with cold and hot temperament based on Persian medicine
Public title
Evaluation of autonomic function in individuals with hot and cold temperaments receiving food recommendations based on Persian medicine viewpoints
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Having physical and mental health based on history and initial examinations
18/5-25: BMI
Not having cardiovascular disease, high blood pressure, neurological diseases, liver and kidney disease, diabetes, thyroid disease, alcohol consumption, rheumatological diseases, autoimmune, immunodeficiency, malignancy, amyloidosis.
Not consuming any special diet
Not taking any medicine or supplement during the last month
Women on the 17th to 27th day of the menstrual cycle
Exclusion criteria:
Travel
A very stressful event
Reluctance to cooperate
Non-compliance with the diet
Illness or death during the implementation of the plan
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethical Committee of Isfahan University of Medical Sciences
Intervention group1: Healthy people with hot temperament receive a diet compatible with the temperament for 3 days. After three days of normal diet (rest), they receive a diet against the temperament for 3 days. These diets include cold/hot foods that will be prescribed by an Iranian medical specialist.
Category
Lifestyle
2
Description
Intervention group 2: Healthy people with cold temperament receive a diet compatible with the temperament for 3 days. After three days of normal diet (rest), they receive a diet against the temperament for 3 days. These diets include cold/hot foods that will be prescribed by an Iranian medical specialist.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Samaneh Pourajam
Street address
Amin hospital,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Email
spourajam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
Hossein Mozafarvandi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Hezar Jerib street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 918 139 1373
Email
Hossein.mozafarvandi@live.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samane Pourajam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
amin hospital,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Fax
Email
s_pourajam@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samane Pourajam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
amin hospital,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Fax
Email
s_pourajam@med.mui.ac.ir
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
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
questionnaire: Mizaj-e-Damagh (temperament of brain) identification in Persian medicine
When the data will become available and for how long
6 months
To whom data/document is available
All researchers in the field of Iranian health and medicine
Under which criteria data/document could be used
Use in the field of healthcare is allowed
From where data/document is obtainable
Send an email to the main organizer of the project.
What processes are involved for a request to access data/document
After checking the received e-mail and evaluation by the moderator, she will take possession of the files at the discretion of the moderators