Determining the effect of following a two-meal diet by eliminating lunch on risk factors and predictors of cardiovascular disease
Design
A randomized controlled trial with parallel group, double blind, randomized, phase 3, with sample size: 120, randomization will be done by Random Allocation
Settings and conduct
This randomized controlled trial will be conducted in Imam Hossein hospital, Semnan, Iran
Participants/Inclusion and exclusion criteria
People who are able to have two-meal diet
Intervention groups
Intervention group: people who have had a three-meal diet and changed it to a two-meal diet.
Control group: having three-meal diet
Main outcome variables
To measure the effect of the intervention, oxidative, apoptotic and inflammatory factors will be measured. Also, to assess this intervention, the predictive factors of cardiovascular diseases will be examined.
General information
Reason for update
Acronym
TDS
IRCT registration information
IRCT registration number:IRCT20200411047024N2
Registration date:2021-11-01, 1400/08/10
Registration timing:prospective
Last update:2021-11-01, 1400/08/10
Update count:0
Registration date
2021-11-01, 1400/08/10
Registrant information
Name
Hossein Sheibani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 2820
Email address
sheybani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of following a two-meal diet eliminating lunch on risk and predictive factors of cardiovascular diseases: A clinical trial
Public title
Effect of two-meal diet on cardiovascular system
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
person's desire to participate in the trial
Having the physical ability to complete the trial
No prohibition to comply with the diet
Having no special diet beforehand
Lack of acute phase of inflammatory diseases and the gastrointestinal tract disorders
Having the body mass index above 24.9
No history of ulcers and inflammation of the upper gastrointestinal tract, as well as a history of gastrointestinal bleeding and inflammatory diseases of the gastrointestinal tract, including Crohn's disease and ulcerative colitis.
Exclusion criteria:
Lack of desire to participate in the trial
Lack of physical ability to complete the trial
Have been banned on trial diet
Having special diet
Acute phase of inflammatory diseases and the gastrointestinal tract disorders
History of ulcers and inflammation of the upper gastrointestinal tract, as well as a history of gastrointestinal bleeding and inflammatory diseases of the gastrointestinal tract, including Crohn's disease and ulcerative colitis.
Advanced diabetes mellitus or insulin-mediated diabetes mellitus due to the potential for damage due to reactive hypoglycemia
History of previous recurrent hypoglycemia
Having severe debilitating disorders at the same time
Consumption high-dose corticosteroids, chemotherapy drugs, and cytotoxic drugs
Having untreated glandular diseases, especially thyroid and adrenal disorders
Body mass index less than 25
Age
From 35 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
This will be a simple random sampling study. Each person is considered as a randomization unit. Random Allocation online software is used for this purpose. In this study, a code is assigned to patients, then these codes, which are in the form of consecutive numbers, are entered into randomization software and this software randomly places people in two groups. Then people enter the assigned group based on the code.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research will be done in form of double blind. Due to the fact that it is not possible to blind the subjects, in this study only the physician and nurse who collects and imports information into the software and the statistical consultant will be unaware of the presence of patients in the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The Qom University of Medical Sciences
Street address
Shahid Lavasani (Saheli) St., Qom, I.R. Iran
City
Qom
Province
Ghoum
Postal code
3716993456
Approval date
2021-08-22, 1400/05/31
Ethics committee reference number
IR.MUQ.REC.1400.95
Health conditions studied
1
Description of health condition studied
Cardiovascular disorders
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified
Primary outcomes
1
Description
Weight
Timepoint
Beginning and end of the study
Method of measurement
Scales
2
Description
Blood pressure
Timepoint
Beginning and end of the study
Method of measurement
Sphygmomanometer
3
Description
Functional status of systole and diastole of left ventricular
Timepoint
Beginning and end of the study
Method of measurement
Transthoracic echocardiography
4
Description
Body fat percentage
Timepoint
Beginning and end of the study
Method of measurement
Bioelectrical impedance device
5
Description
Carotid intimal thickness
Timepoint
Beginning and end of the study
Method of measurement
Carotid sonography
6
Description
CRP serum level
Timepoint
Beginning and end of the study
Method of measurement
CRP kit quantitatively made by Pishtazteb company
7
Description
Lipid profile
Timepoint
Beginning and end of the study
Method of measurement
Lipid assay kit
8
Description
The level of malonyl dialdehyde
Timepoint
Beginning and end of the study
Method of measurement
Standard kit of malonyl dialdehyde
9
Description
The level of BAX
Timepoint
Beginning and end of the study
Method of measurement
Standard kit of BAX
10
Description
The level of Bcl2
Timepoint
Beginning and end of the study
Method of measurement
Standard kit of Bcl2
11
Description
Fasting Blood Sugar Test
Timepoint
Beginning and end of the study
Method of measurement
glucometer
12
Description
HbA1c
Timepoint
Beginning and end of the study
Method of measurement
affinity chromatography methods
13
Description
uric acid test
Timepoint
Beginning and end of the study
Method of measurement
Uric acid laboratory test kit
14
Description
Hip circumference size
Timepoint
Beginning and end of the study
Method of measurement
sewing meter
15
Description
Waist size
Timepoint
Beginning and end of the study
Method of measurement
sewing meter
16
Description
Serum insulin levels
Timepoint
Beginning and end of the study
Method of measurement
Laboratory Insulin Assay Kit
17
Description
insulin resistance
Timepoint
Beginning and end of the study
Method of measurement
Oral glucose tolerance test
18
Description
serum glutathione
Timepoint
Beginning and end of the study
Method of measurement
Glutathione Laboratory Assay Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group has a two-meal diet, which means that only two meals will be served in 24 hours. This diet will last for 16 weeks (4 months). The first meal will be in the early morning and the second meal in the evening
Category
Lifestyle
2
Description
Control group: The normal diet, which is three meals a day
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Hossein Sheibani
Street address
Imam Hossein Hospital of Shahroud, Baghzendan street, Shahroud, Semnan, Iran
City
Shahroud
Province
Semnan
Postal code
3619611151
Phone
+98 23 3234 2000
Email
sheybani@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of The Qom University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
Shahid Lavasani (Saheli) St., Qom, I.R. Iran
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 4011
Email
research@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of The Qom 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
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Sheibani
Position
Assistant Professor of Cardiology Department of Clinical Sciences, School of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahroud University of Medical Sciences, Tehran Blvd, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
sheybani@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Sheibani
Position
Assistant Professor of Cardiology Department of Clinical Sciences, School of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahroud University of Medical Sciences, Tehran Blvd, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
sheybani@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Sheibani
Position
Assistant Professor of Cardiology Department of Clinical Sciences, School of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahroud University of Medical Sciences, Tehran Blvd, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
sheybani@shmu.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
Some of the information about the main outcome will be available to be published
When the data will become available and for how long
Access period starts 3 months after publishing of results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There should be no conflict of interest. Responsibility and maintaining the ethics of the researcher
From where data/document is obtainable
Contact Dr. Hossein Sheibani via email: sheybani@shmu.ac.ir
What processes are involved for a request to access data/document
Citing the RCT code and the study done and the reason for the need for the results with the mentioned conditions can send the request