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IRCT20230820059191N1 IRCT 2023-08-22 Mashhad University of Medical Sciences The effect of time restricted eating on cognitive function in men with metabolic syndrome The effect of time restricted eating on cognitive function in men with metabolic syndrome: a randomized controlled trial 2023-09-01 anticipated 40 Complete https://irct.ir/trial/72133 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: using sealed envelopes in a container that according to the sample size, 20 with control text and 20 with intervention text, which the participant will randomly choose. N/A Metabolic syndrome. 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 limit 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. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome or similar, can be shared. When: Data access will start 6 months after the results are published. To whom: The data will be available to researchers working in academic and scientific institutions and people working in industry if action is taken. Conditions: The conditions of using non-identifiable data or other research achievements will be reviewed on a case-by-case basis after sending an official request by the Faculty of Medical Sciences. Where to obtain: Dr. Mohsen Nemati Address: Mashhad, Azadi Square, East Gate of Ferdowsi University Campus, Mashhad University of Medical Sciences, Faculty of Medicine, Department of Nutrition Postal Code: 9177948564 Email: NematyM@mums.ac.ir Phone: 0098 51 38827034 How to obtain: The applicant must send the data request with details via e-mail, and the request will be provided to the applicant after it is reviewed by the researchers and Mashhad University of Medical Sciences and if approved. Comments:
public Mohammad Masoumvand
Azadi Square, East Gate of Ferdowsi University of Mashhad, Faculty of Medicine, Department of Nutrition
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 masoumvandm4001@gmail.com Mashhad University of Medical Sciences scientific Mohsen Nematy
Azadi Square, East Gate of Ferdowsi University of Mashhad, Faculty of Medicine, Department of Nutrition
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 NematyM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Men aged between 18 and 65 years, defined work and sleep schedule more than 14 hours of daily intake diagnosis of metabolic syndrome according to the International Diabetes Federation (IDF) definition mild to moderate activity level according to the IPAQ questionnaire 18 years 65 years Male Diabetes thyroid disorders based on thyroid tests or thyroxine intake eating disorders serious diseases that affect food intake such as cancer inability to follow a time-limited meal plan sleep disorder diagnosed by a psychiatrist or psychologist known disorders Psychology or psychiatry that affect the quality of sleep (anxiety, depression, stress) use of drugs that change the quality or pattern of sleep (sedative and sleep-inducing drugs, stimulant drugs). Drugs that take dopamine agonist drugs, procyclidine, primidone, valproic acid, olanzapine, topiramate, gabapentin, fluoxetine, sertraline, quetiapine, and trazodone. 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 limit 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. Changes in eating inhibition behavior resulting from go/no go test scores. Timepoint: The beginning of the study and the end of the sixth week. Method of measurement: go/nogo cognitive test. Changes in cognitive flexibility. Timepoint: The beginning of the study and the end of the sixth week. Method of measurement: Wisconsin cognitive Test. Active memory changes. Timepoint: The beginning of the study and the end of the sixth week. Method of measurement: Wisconsin cognitive Test. Mashhad University of Medical Sciences Approved 2023-06-13 Ethics Committee of Mashhad University of Medical Sciences Azadi Square, East Gate of Ferdowsi University of Mashhad Campus, Mashhad University of Medical Sciences, Faculty of Medicine Mashhad Razavi Khorasan Iran (Islamic Republic of)