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IRCT20230105057054N1 IRCT 2023-03-28 Esfahan University of Medical Sciences Comparison of the effect of MIND diet and propolis supplement on metabolic syndrome and cognitive function MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay diet) Comparison of the effects of MIND diet and propolis supplementation on metabolic syndrome indices and cognitive function and its areas in people with metabolic syndrome. Randomized controlled clinical trial. 2023-05-31 anticipated 84 Complete https://irct.ir/trial/68419 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups. samples will be allocated to the intervention and control groups using a randomized block design. The randomization unit is the individual that will be used from the table of random numbers. Eligible people visiting the clinic enter in 28 blocks of three. The first 3 eligible subjects are placed in the first block, the second 3 in the second block, and the 28th 3 in the 28th block. For all three intervention and control groups codes A, B, and C are named. The subjects of each block are based on the table of random numbers, so that if the random number is 1-3, treatment A, if it is 4-6, treatment B, and if it is 7-9, treatment C (Random numbers generated by the computer can also be used for this purpose). Therefore, based on the received random number, the first person in the block is assigned to the treatment code corresponding to the random number. This process will continue until 28 blocks are completed. 3 Condition 1: metabolic syndrome. Condition 2: cognitive function. Intervention 1: First intervention group: MIND diet and placebo. The counseling plan for the intervention diet group will include instructions on what foods to include in the diet, the paths to provide these foods. The dietary regimen being employed in this study is the MIND diet, as outlined by Morris et al in its expanded form. Participants in the MIND diet group will receive instructions to modify their dietary content, emphasizing natural and plant-based foods and consuming berries and green leafy vegetables, whole grains, fish, nuts, and olive oil and with restricted consume of animal’s food and high saturated fat is recommended. According to Islamic customs and culture, the people of Iran are bound not to consume alcoholic beverages, so, we persuade our patients to use grapes, grape juice, and raisins for correcting. For each person, the MIND diet will be provided specifically for seven days a week along with counseling for at least 30 minutes, and continue for 3 monthsو and people will be asked to visit the relevant center for three days (days 7, 45, and 80 of the study). and the minimum time for each person in each meeting will be 15 minutes for counseling and checking compliance with the diet. In addition, routine dietary advice will be used, which will include verbal and written general data about healthy food selections according to the healthy food plate (50-60% carbohydrates, 5-20% protein, and 30% fat). All participants will get acquainted with the principles of food recommendations, which are as follows: Eat slowly and chew your food completely and with pleasure. Instead of frying foods, use steamed, boiled, and grilled foods. take off any excess fat and skin from your chicken or meat before cooking. use whole-meal bread and mixed oats and rice instead of simple rice and pasta. refrain from removing any meals. Eat frequent but small meals. Try to limit your intake of sugary and fatty foods. This combination is more similar to the food pattern of Iranians. Microcrystalline cellulose placebo will also be used in this group, the drug and placebo will be completely similar which will be prepared in the Department of Pharmacology of Mashhad University of Medical Sciences and none of the participants and researchers will know about them until the end of the study. Intervention 2: Second intervention group: MIND diet and propolis supplementation. The counseling plan for the intervention diet group will include instructions on what foods to include in the diet, the paths to provide these foods. The dietary regimen being employed in this study is the MIND diet, as outlined by Morris et al in its expanded form. Participants in the MIND diet group will receive instructions to modify their dietary content, emphasizing natural and plant-based foods and consuming berries and green leafy vegetables, whole grains, fish, nuts, and olive oil and with restricted consume of animal’s food and high saturated fat is recommended. According to Islamic customs and culture, the people of Iran are bound not to consume alcoholic beverages, so, we persuade our patients to use grapes, grape juice, and raisins for correcting. For each person, the MIND diet will be provided specifically for seven days a week along with counseling for at least 30 minutes, and continue for 3 monthsو and people will be asked to visit the relevant center for three days (days 7, 45, and 80 of the study). and the minimum time for each person in each meeting will be 15 minutes for counseling and checking compliance with the diet. In addition, routine dietary advice will be used, which will include verbal and written general data about healthy food selections according to the healthy food plate (50-60% carbohydrates, 5-20% protein, and 30% fat). All participants will get acquainted with the principles of food recommendations, which are as follows: Eat slowly and chew your food completely and with pleasure. Instead of frying foods, use steamed, boiled, and grilled foods. take off any excess fat and skin from your chicken or meat before cooking. use whole-meal bread and mixed oats and rice instead of simple rice and pasta. refrain from removing any meals. Eat frequent but small meals. Try to limit your intake of sugary and fatty foods. This combination is more similar to the food pattern of Iranians. Also it will be recommended to take a propolis supplement which will be prepared in the Department of Pharmacology of Mashhad University of Medical Sciences (Take 450 mg twice daily before lunch and dinner) for 3 months. Intervention 3: Control group: microcrystalline cellulose placebo. For these individuals, routine dietary advice will be used, which will include verbal and written general data about to ensure your diet is balanced, aim for healthy food choices that follow the guidelines of the healthy food plate. This means consuming around 50-60% carbohydrates, 5-20% protein, and 30% fat. In this case, none of participants will receive food menus and will get acquainted with the principles of food recommendations, as follows: Eat slowly and chew your food completely and with pleasure. Instead of frying foods, use steamed, boiled, and grilled foods. take off any excess fat and skin from your chicken or meat before cooking. use whole-meal bread and mixed oats and rice instead of simple rice and pasta. refrain from removing any meals. Eat frequent but small meals. Try to limit your intake of sugary and fatty foods. In addition to the usual food recommendations, the microcrystalline cellulose placebo will be used. The drug and the placebo will be completely similar which will be prepared in the Department of Pharmacology of Mashhad University of Medical Sciences and none of the participants and researchers will know about them until the end of the study. Yes - There is a plan to make this available What will be shared: All data will be available upon reasonable request from Prof. Zamzam Paknahad When: 12 months after publication of results To whom: Academic users Conditions: Academic purposes Where to obtain: paknahad@hlth.mui.ac.ir How to obtain: Upon receipt of the request, the data will be sent as soon as possible. Comments:
public Dr Zamzam Paknahad
Hezar jerib
Isfehan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3166 paknahad@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Zamzam paknahad
Hezar jerib
Isfehan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3166 paknahad@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Participants must provide informed consent prior to engaging in the study Adults (18-60 years old) have metabolic syndrome 18 years 60 years Both Suffering from thyroid diseases, anemia, diabetes, neurological and psychiatric illnesses containing depression, Parkinson's disease, Alzheimer's disease, mental disorders and, a history of severe medical treatment. Have a stroke or transient ischemic attack in the last 3 months. Have a history of brain damage, liver and kidney disease, hepatitis C or HIV. have been diagnosed with cancer in the last five years. Obese people with a BMI higher than 40 E88.81 R41 Metabolic syndrome Other symptoms and signs involving cognitive functions and awareness Treatment - Other Treatment - Other Placebo First intervention group: MIND diet and placebo. The counseling plan for the intervention diet group will include instructions on what foods to include in the diet, the paths to provide these foods. The dietary regimen being employed in this study is the MIND diet, as outlined by Morris et al in its expanded form. Participants in the MIND diet group will receive instructions to modify their dietary content, emphasizing natural and plant-based foods and consuming berries and green leafy vegetables, whole grains, fish, nuts, and olive oil and with restricted consume of animal’s food and high saturated fat is recommended. According to Islamic customs and culture, the people of Iran are bound not to consume alcoholic beverages, so, we persuade our patients to use grapes, grape juice, and raisins for correcting. For each person, the MIND diet will be provided specifically for seven days a week along with counseling for at least 30 minutes, and continue for 3 monthsو and people will be asked to visit the relevant center for three days (days 7, 45, and 80 of the study). and the minimum time for each person in each meeting will be 15 minutes for counseling and checking compliance with the diet. In addition, routine dietary advice will be used, which will include verbal and written general data about healthy food selections according to the healthy food plate (50-60% carbohydrates, 5-20% protein, and 30% fat). All participants will get acquainted with the principles of food recommendations, which are as follows: Eat slowly and chew your food completely and with pleasure. Instead of frying foods, use steamed, boiled, and grilled foods. take off any excess fat and skin from your chicken or meat before cooking. use whole-meal bread and mixed oats and rice instead of simple rice and pasta. refrain from removing any meals. Eat frequent but small meals. Try to limit your intake of sugary and fatty foods. This combination is more similar to the food pattern of Iranians. Microcrystalline cellulose placebo will also be used in this group, the drug and placebo will be completely similar which will be prepared in the Department of Pharmacology of Mashhad University of Medical Sciences and none of the participants and researchers will know about them until the end of the study. Second intervention group: MIND diet and propolis supplementation. The counseling plan for the intervention diet group will include instructions on what foods to include in the diet, the paths to provide these foods. The dietary regimen being employed in this study is the MIND diet, as outlined by Morris et al in its expanded form. Participants in the MIND diet group will receive instructions to modify their dietary content, emphasizing natural and plant-based foods and consuming berries and green leafy vegetables, whole grains, fish, nuts, and olive oil and with restricted consume of animal’s food and high saturated fat is recommended. According to Islamic customs and culture, the people of Iran are bound not to consume alcoholic beverages, so, we persuade our patients to use grapes, grape juice, and raisins for correcting. For each person, the MIND diet will be provided specifically for seven days a week along with counseling for at least 30 minutes, and continue for 3 monthsو and people will be asked to visit the relevant center for three days (days 7, 45, and 80 of the study). and the minimum time for each person in each meeting will be 15 minutes for counseling and checking compliance with the diet. In addition, routine dietary advice will be used, which will include verbal and written general data about healthy food selections according to the healthy food plate (50-60% carbohydrates, 5-20% protein, and 30% fat). All participants will get acquainted with the principles of food recommendations, which are as follows: Eat slowly and chew your food completely and with pleasure. Instead of frying foods, use steamed, boiled, and grilled foods. take off any excess fat and skin from your chicken or meat before cooking. use whole-meal bread and mixed oats and rice instead of simple rice and pasta. refrain from removing any meals. Eat frequent but small meals. Try to limit your intake of sugary and fatty foods. This combination is more similar to the food pattern of Iranians. Also it will be recommended to take a propolis supplement which will be prepared in the Department of Pharmacology of Mashhad University of Medical Sciences (Take 450 mg twice daily before lunch and dinner) for 3 months. Control group: microcrystalline cellulose placebo. For these individuals, routine dietary advice will be used, which will include verbal and written general data about to ensure your diet is balanced, aim for healthy food choices that follow the guidelines of the healthy food plate. This means consuming around 50-60% carbohydrates, 5-20% protein, and 30% fat. In this case, none of participants will receive food menus and will get acquainted with the principles of food recommendations, as follows: Eat slowly and chew your food completely and with pleasure. Instead of frying foods, use steamed, boiled, and grilled foods. take off any excess fat and skin from your chicken or meat before cooking. use whole-meal bread and mixed oats and rice instead of simple rice and pasta. refrain from removing any meals. Eat frequent but small meals. Try to limit your intake of sugary and fatty foods. In addition to the usual food recommendations, the microcrystalline cellulose placebo will be used. The drug and the placebo will be completely similar which will be prepared in the Department of Pharmacology of Mashhad University of Medical Sciences and none of the participants and researchers will know about them until the end of the study. Fasting blood sugar. Timepoint: Before and after study. Method of measurement: blood sample. Triglyceride. Timepoint: Before and after study. Method of measurement: blood sample. High density lipoprotein cholesterol. Timepoint: Before and after study. Method of measurement: blood sample. Blood pressure. Timepoint: Before and after study. Method of measurement: sphygmomanometer. Cognitive function. Timepoint: Before and after study. Method of measurement: Neuropsychiatry Unit Cognitive Assessment. Waist. Timepoint: Before and after study. Method of measurement: inflexible meter. Esfahan University of Medical Sciences Approved 2023-02-05 Ethics Committee of Isfahan University of Medical Sciences Hazar Jerib Street, Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)