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IRCT20200411047024N2 IRCT 2021-11-01 Research Deputy of The Qom University of Medical Sciences Effect of two-meal diet on cardiovascular system TDS Determining the effect of following a two-meal diet eliminating lunch on risk and predictive factors of cardiovascular diseases: A clinical trial 2021-12-22 anticipated 120 Complete https://irct.ir/trial/58905 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Cardiovascular disorders. Intervention 1: 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. Intervention 2: Control group: The normal diet, which is three meals a day. Yes - There is a plan to make this available What will be shared: Some of the information about the main outcome will be available to be published When: Access period starts 3 months after publishing of results To whom: It will be available to researchers working in academic and scientific institutions Conditions: There should be no conflict of interest. Responsibility and maintaining the ethics of the researcher Where to obtain: Contact Dr. Hossein Sheibani via email: sheybani@shmu.ac.ir How to obtain: 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 Comments:
public Hossein Sheibani
Shahroud University of Medical Sciences, Tehran Blvd, Hafte Tir Square
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 1609 sheybani@shmu.ac.ir Shahroud University of Medical Sciences scientific Hossein Sheibani
Shahroud University of Medical Sciences, Tehran Blvd, Hafte Tir Square
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 1609 sheybani@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) 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. 35 years no limit Both 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 I51.6 Cardiovascular disease, unspecified Lifestyle Lifestyle 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 Control group: The normal diet, which is three meals a day Weight. Timepoint: Beginning and end of the study. Method of measurement: Scales. Blood pressure. Timepoint: Beginning and end of the study. Method of measurement: Sphygmomanometer. Functional status of systole and diastole of left ventricular. Timepoint: Beginning and end of the study. Method of measurement: Transthoracic echocardiography. Body fat percentage. Timepoint: Beginning and end of the study. Method of measurement: Bioelectrical impedance device. Carotid intimal thickness. Timepoint: Beginning and end of the study. Method of measurement: Carotid sonography. CRP serum level. Timepoint: Beginning and end of the study. Method of measurement: CRP kit quantitatively made by Pishtazteb company. Lipid profile. Timepoint: Beginning and end of the study. Method of measurement: Lipid assay kit. The level of malonyl dialdehyde. Timepoint: Beginning and end of the study. Method of measurement: Standard kit of malonyl dialdehyde. The level of BAX. Timepoint: Beginning and end of the study. Method of measurement: Standard kit of BAX. The level of Bcl2. Timepoint: Beginning and end of the study. Method of measurement: Standard kit of Bcl2. Fasting Blood Sugar Test. Timepoint: Beginning and end of the study. Method of measurement: glucometer. HbA1c. Timepoint: Beginning and end of the study. Method of measurement: affinity chromatography methods. Uric acid test. Timepoint: Beginning and end of the study. Method of measurement: Uric acid laboratory test kit. Hip circumference size. Timepoint: Beginning and end of the study. Method of measurement: sewing meter. Waist size. Timepoint: Beginning and end of the study. Method of measurement: sewing meter. Serum insulin levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory Insulin Assay Kit. Insulin resistance. Timepoint: Beginning and end of the study. Method of measurement: Oral glucose tolerance test. Serum glutathione. Timepoint: Beginning and end of the study. Method of measurement: Glutathione Laboratory Assay Kit. Research Deputy of The Qom University of Medical Sciences Approved 2021-08-22 Ethics committee of The Qom University of Medical Sciences Shahid Lavasani (Saheli) St., Qom, I.R. Iran Qom Ghoum Iran (Islamic Republic of)