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IRCT20130223012571N9 IRCT 2023-10-13 Yazd University of Medical Sciences The effect of MIND diet on physical fitness Investigating the effect of MIND diet on physical fitness and anthropometric indices in female high school students: a cluster randomized controlled trial 2023-11-06 anticipated 300 Complete https://irct.ir/trial/72723 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Among the high school girls' schools in Yazd that are eligible to enter the study, 6 schools are randomly selected using SPSS software. 6 envelopes containing intervention or control codes prepared in advance are provided to the investigators. After opening each envelope, the investigators identify each school. In each school, according to the assigned group, 50 students are randomly selected (by generating 50 random numbers and choosing from the list of students of each school) and enter the study. N/A High school girl students. Intervention 1: Intervention group: Mediterranean-DASH Diet Intervention for Neurodegenerative Delay The MIND diet is a combination of the Mediterranean diet and DASH, which will be adjusted according to the ratio of macronutrients: 50-60% carbohydrates, 25-30% fat, and 15-20% protein for the intervention group. The MIND diet contains high amounts of green leafy vegetables and other vegetables, berries, nuts, olive oil, whole grains, fish, legumes, and poultry. Intervention 2: Control group: he usual diet which is similar to the usual Iranian diet with a macro-nutrient composition of 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins. Yes - There is a plan to make this available What will be shared: The general characteristics of the participants (without mentioning names and personal information) as well as the data for baseline and post-intervention values for primary and secondary outcomes will be made available to those interested after submitting the researchers' request and reviewing the principal investigators. When: The data will be available to the researchers when the related articles are published. To whom: The data will be available for all researchers interested in the subject. Conditions: Data will be available if the interested researcher(s) fills the proposal for a joint project and the sponsor of the study (Shahid Sadoughi University of Medical Sciences) confirms the protocol of the project. Where to obtain: he data can be obtained from:​Dr. Amin Salehi-Abargouei, Ph.D. in Nutrition Department of Nutrition Faculty of Public Health Sahid Sadoughi University of Medical Sciences Yazd, PO Code 8915173160 Iran Tel:+98-35-31492229 Fax:+98-35-38209119 Email: abargouei@ssu.ac.ir Alternate email: abargouei@gmail.com How to obtain: The interested investigators should provide a brief description of the data needed and their reason for asking the data by contacting the principal investigator. The principal investigator will assess the possibility of sharing the data and if applicable will ask for a joint proposal. The joint proposal will be sent to the vice chancellery for research, ShahidSadoughi University of Medical Sciences (the sponsor) and the data will be sent by the principal investigator if the sponsor confirms the cooperation. Comments:
public Fatemeh Moghtaderi
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) ​8915173160 +98 35 3820 9100 moghtaderi.fatemeh@gmial.com Yazd University of Medical Sciences scientific Dr. Amin Salehi-Abargouei
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) ​8915173160 +98 35 3820 9100 abargouei@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) High school girls aged 15 to 17 years Informed consent of participants and their parents Having regular menstruation 15 years 17 years Female cardiovascular diseases History of liver and kidney disease Suffering from cancer or a history of cancer Having a known cardiovascular disease or a history of heart surgery Having type 2 diabetes (fasting blood sugar above 126) or type 1 diabetes Recipient of a special diet Having any underlying disease People who do professional sports or are athletes Allergy to any of the components of the MIND diet Obese people (over 97th percentile) History of women's diseases and use of hormonal drugs Lifestyle Lifestyle Intervention group: Mediterranean-DASH Diet Intervention for Neurodegenerative Delay The MIND diet is a combination of the Mediterranean diet and DASH, which will be adjusted according to the ratio of macronutrients: 50-60% carbohydrates, 25-30% fat, and 15-20% protein for the intervention group. The MIND diet contains high amounts of green leafy vegetables and other vegetables, berries, nuts, olive oil, whole grains, fish, legumes, and poultry. Control group: he usual diet which is similar to the usual Iranian diet with a macro-nutrient composition of 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins. Weight. Timepoint: The beginning and end of the study (after three months). Method of measurement: A scale with an accuracy of 100 grams. Waist circumference. Timepoint: The beginning and end of the study (after three months). Method of measurement: tape measure with an accuracy of 0.5 cm. Body mass index. Timepoint: The beginning and end of the study (after three months). Method of measurement: The ratio of weight to the square of height. Percentage of fat mass. Timepoint: The beginning and end of the study (after three months). Method of measurement: body composition analyzer (Omron). Skeletal muscle percentage. Timepoint: The beginning and end of the study (after three months). Method of measurement: body composition analyzer (Omron). Cardiorespiratory fitness. Timepoint: The beginning and end of the study (after three months). Method of measurement: 20 m shuttle run test. Handgrip strength. Timepoint: The beginning and end of the study (after three months). Method of measurement: Handgrip. Anaerobic power. Timepoint: The beginning and end of the study (after three months). Method of measurement: Standing broad jump. Depression score. Timepoint: The beginning and end of the study (after three months). Method of measurement: PHQ-9 and DASS-21 questionnaires. Anxiety score. Timepoint: The beginning and end of the study (after three months). Method of measurement: GAD-7 and DASS-21 questionnaires. Stress score. Timepoint: The beginning and end of the study (after three months). Method of measurement: DASS-21 questionnaire. Overall health score. Timepoint: The beginning and end of the study (after three months). Method of measurement: GHQ questionnaire. The obtained score of premenstrual syndrome symptoms. Timepoint: The beginning and end of the study (after three months). Method of measurement: PSST questionnaire. The obtained score of menstrual distress. Timepoint: The beginning and end of the study (after three months). Method of measurement: MMDQ questionnaire. Sleep quality and quantity. Timepoint: The beginning and end of the study (after three months). Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Mental health. Timepoint: The beginning and end of the study (after three months). Method of measurement: SDQ questionnaire. Health-related quality of life. Timepoint: The beginning and end of the study (after three months). Method of measurement: SF-36 questionnaire. Yazd University of Medical Sciences Approved 2023-09-11 Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran. Yazd Yazd Iran (Islamic Republic of)