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Evaluation of the acute effect of Traditional Persian medicine based hot and cold foods on Metabolic Responses and Arterial Stiffness in healthy men

Protocol summary

Study aim
Examination of the effect of Traditional Persian medicine based hot and cold foods on metabolic responses and arterial stiffness indexes during postprandial phase in adult males with hot and cold temperaments
Design
crossover clinical trial
Settings and conduct
Imam Reza Hospital
Participants/Inclusion and exclusion criteria
a BMI of 18.5-25 kg/m2, body fat percent between 12-22%, waist circumference <90cm aged 20-25 years Men Signing the Written informed consent willing to undertake required fasting durations
Intervention groups
Intervention group: men with hot and cold temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours
Main outcome variables
thermic effect of the test meals , Resting measurements of energy expenditure and substrate, lipide profile, insulin, blood sugar, arterial stiffness index including: pulse wave velocity , augmentation index

General information

Reason for update
Acronym
HCFMR
IRCT registration information
IRCT registration number: IRCT20200417047105N1
Registration date: 2020-04-19, 1399/01/31
Registration timing: registered_while_recruiting

Last update: 2020-04-19, 1399/01/31
Update count: 0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Mohsen Zakerian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2423
Email address
zakerianmohsen@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the acute effect of Traditional Persian medicine based hot and cold foods on Metabolic Responses and Arterial Stiffness in healthy men
Public title
Traditional Persian medicine based hot and cold foods and Metabolic Responses and Arterial Stiffness
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
a BMI of 18.5-25 kg/m2, body fat percent between 12-22%, waist circumference <90cm aged 20-25 years Men Signing the Written informed consent willing to undertake required fasting durations
Exclusion criteria:
Use of supplement for weight loss and weight gain Professional athlete who cannot consume test meals due to intolerances/dietary preferences (i.e. vegan, gluten, milk proteins) change in body weight greater than 10% in 6 months past Current smoking use of medications that might affect study outcomes such as hypo and hyper thyroid and caffein history of cardiovascular events (acute myocardial infarction, stroke, etc.), hypertension, diabetes mellitus, dyslipidaemia, pharmacological treatment for any of these conditions, neurological and/or neuropsychological disease or the consumption of toxic substances
Age
From 20 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.MUMS.REC.1398.014

Health conditions studied

1

Description of health condition studied
Men with Traditional Persian Medicine based hot and cold temperaments
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified

Primary outcomes

1

Description
respiratory quotient
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours)
Method of measurement
Indirect calorimetry

2

Description
resting energy expenditure
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours)
Method of measurement
Indirect calorimetry

3

Description
total energy expenditure
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours)
Method of measurement
Indirect calorimetry

4

Description
Diet induced thermogenesis
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2 hours until 4 hours)
Method of measurement
Indirect calorimetry

Secondary outcomes

1

Description
pulse wave analysis
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours)
Method of measurement
Tonometry

2

Description
pulse wave velocity
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours)
Method of measurement
Tonometry

3

Description
blood sugar
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours)
Method of measurement
blood sample

4

Description
Insulin
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours)
Method of measurement
blood sample

5

Description
Lipid profile
Timepoint
during 4 hours after test meal(half hours after meal and thus every 2hours until 4 hours)
Method of measurement
blood sample

Intervention groups

1

Description
Intervention group: men with hot temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours
Category
Other

2

Description
Intervention group: Intervention group: men with cold temperament that will receive two test meals in 2 days including Traditional based medicine hot and cold food. they will evaluate during 4hours
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maliheh Motavasselian
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2423
Email
MotavasselianM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University, Qoreishi Center, Daneshgah street.
City
Mashhad
Province
South Khorasan
Postal code
13131 - 99137
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Zakerian
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Persian Medicine
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
mashahd
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2423
Email
zakerianmohsen@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Zakerian
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Persian Medicine
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98513002423
Email
zakerianmohsen@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Zakerian
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Persian Medicine
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2423
Email
Zakerianmohsen@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
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
When the data will become available and for how long
The non-identifiable individual participant data will become available after the publication of the relevant articles.
To whom data/document is available
they will be available for people working in academic institutions and people working in businesses can also apply to receive it.
Under which criteria data/document could be used
The non-identifiable individual participant data can only be used for research.
From where data/document is obtainable
The non-identifiable individual participant data will be obtainable by sending an e-mail to Mohsen Zakerian (Zakerianmohsen@gmail.com)
What processes are involved for a request to access data/document
Other researchers in academic institutions can send their request by e-mail to Mohsen Zakarian. The data will be sent to them after consulting and approving the research team.
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