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IRCT20201230049889N1 IRCT 2022-08-14 Mashhad University of Medical Sciences The Effect of Time-Restricted Eating on Arterial Stiffness Indices in Patients with Metabolic Syndrome The Effect of Time-Restricted Eating versus Standard Dietary Advice on Arterial Stiffness Indices in Men with Metabolic Syndrome 2023-10-23 anticipated 48 Complete https://irct.ir/trial/64485 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: simple Randomization Unit: Individual Randomization tool: sealed envelope (SNOSE: sequentially numbered, opaque, sealed envelopes) How to make a random sequence: Randomaize.com randomization site Explanation about allocation concealment: Random numbers are prepared with the help of Randomaize.com and printed and placed inside the envelope by a member of the research team. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then first, the purpose of the study is explained to the person who meets the listed conditions. If desired, the person signs the informed consent form and takes an envelope. Then opens it and based on the contents of the envelope, the person is entered in the intervention or control group. N/A Condition 1: Metabolic syndrome. Condition 2: Arterial stiffness indices. Condition 3: Time-restricted eating. Intervention 1: Intervention group: In the intervention group, people will receive food in a period of 10 hours. It is recommended that this period be between 6 am and 8 pm. All foods and drinks except water, tea and coffee without added sweeteners should be consumed during this period. Due to not affecting the quality of sleep, tea and coffee consumption is allowed before 8 pm. With the help of researchers, participants will choose the best time frame that fits their life schedule. The patients' diet is according to their taste and freely, and there are no food restrictions. Participants will be explained about a healthy diet based on national dietary recommendations. Intervention 2: Control group: The control group will have a diet without time restriction and will receive the necessary recommendations about a healthy diet based on national dietary guidelines. In this group, the diet of the patients is according to their taste and freely, and there are no food restrictions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Persian cohort center will provide the data to researchers in a case-by-case basis and the center has the complete ownership of the data.
public Aliyeh Ghannadzadeh Yazdi
Nutrition Department, School of Medicine, East door of Ferdowsi University, Azadi Sq.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 GhannadzadehYA981@mums.ac.ir Mashhad University of Medical Sciences scientific Mohsen Nemati
Nutrition Department, School of Medicine, East door of Ferdowsi University, Azadi Sq.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 NematyM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Men between the ages of 18 and 65 Body mass index (BMI) below 35 Diagnosis of metabolic syndrome according to the International Diabetes Federation (IDF) definition Willingness to participate in the study by signing the informed consent form 18 years 65 years Male Diabetes Thyroid disorders based on thyroid tests or thyroxine use Eating disorders Serious diseases that affect food intake, such as cancer Using supplements that contain compounds other than vitamins and minerals Inability to follow time-restricted eating diet Specific work and sleep schedule The duration of receiving daily food less than 14 hours E88.81 Metabolic syndrome Lifestyle N/A Intervention group: In the intervention group, people will receive food in a period of 10 hours. It is recommended that this period be between 6 am and 8 pm. All foods and drinks except water, tea and coffee without added sweeteners should be consumed during this period. Due to not affecting the quality of sleep, tea and coffee consumption is allowed before 8 pm. With the help of researchers, participants will choose the best time frame that fits their life schedule. The patients' diet is according to their taste and freely, and there are no food restrictions. Participants will be explained about a healthy diet based on national dietary recommendations. Control group: The control group will have a diet without time restriction and will receive the necessary recommendations about a healthy diet based on national dietary guidelines. In this group, the diet of the patients is according to their taste and freely, and there are no food restrictions. Pulse wave velocity (PWV). Timepoint: At the beginning of the study and after 6 weeks from the start of the study. Method of measurement: Pulse Wave Velocity device. Body weight. Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Scales. Waist circumference. Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Meter. Body composition. Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Bioelectric Impedance Analysis (BIA) device. Complete blood count (CBC). Timepoint: At the beginning of the study (fasting and 120 minutes after a meal) and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Alanine transaminase (ALT). Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Aspartate transaminase (AST). Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. C-Reactive Protein (CRP). Timepoint: At the beginning of the study (fasting and 120 minutes after a meal) and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Total cholesterol. Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Triglyceride. Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. High-density lipoprotein (HDL). Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Low-density lipoprotein (LDL). Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Blood glucose. Timepoint: At the beginning of the study (fasting, 60 minutes after and 120 minutes after a meal) and 3 weeks and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Insulin. Timepoint: At the beginning of the study (fasting, 60 minutes after and 120 minutes after a meal) and 3 weeks and 6 weeks after the start of the study. Method of measurement: Biochemical analysis of blood sample. Insulin resistance. Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Calculation of Homeostatic Model Assessment (HOMA). Blood pressure. Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: Sphygmomanometer. Metabolic rate. Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Indirect calorimetry. Appetite status. Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Visual Analog Scale (VAS). Physical activity. Timepoint: 3 days at the beginning of the study and 3 days at the end of the study. Method of measurement: Pedometer. Sleep status. Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Pitssburg Questionnaire. Quality of life. Timepoint: At the beginning of the study and 6 weeks after the start of the study. Method of measurement: Short form of World Health Organization quality of life questionnaire (WHOQOL-BREF). Dietary intake. Timepoint: At the beginning of the study and 3 weeks and 6 weeks after the start of the study. Method of measurement: 3-day 24-hour recall. Mashhad University of Medical Sciences Approved 2022-05-31 Ethics committee of Mashhad University of Medical Sciences School of Medicine, Mashhad University of Medical Sciences, East door of Ferdowsi University, Azadi Sq. Mashhad Razavi Khorasan Iran (Islamic Republic of)