]>
IRCT20200217046524N1 IRCT 2020-05-25 Semnan University of Medical Sciences Assessment the effect of green tea and wheat bran on metabolic syndrome Assessment the effect of green tea and wheat bran on diagnostic indicators of metabolic syndrome in Shahroud drivers in 2020 2020-03-20 anticipated 90 Complete https://irct.ir/trial/45929 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation will be done using six Permuted Block Randomization methods. The total number of participants in this study is 90, which will be included in 3 groups of 30 people (2 intervention groups and one control group). 10 blocks of 6 will be determined and we will give each block from one to 10 numbers. Then, using the table of random numbers, 15 one-digit numbers (between 0 and 9) are selected completely randomly, and based on each of the selected numbers, a block is determined from the ten blocks (each of the randomly numbers will be corresponding to the same block number except for the number zero which corresponds to the tenth block). Eligible individuals are assigned to three groups based on the arrangement of each block from left to right. 3 Metabolic Syndrome. Intervention 1: First intervention group: Green Tea- To the Green Tea Group will be recommended 3 cups of simple green teabag (one gram) daily from without added sugar or milk for 2 months. There will be provided from hygienic packaging products from Golestan brand with standard logo. Intervention 2: Second intervention group: Wheat bran- To the wheat bran group will be recommended 3.5 gram wheat bran powder based on individual taste with yogurt or rice daily for 2 months. There will be provided from hygienic packaging products of Nan Avaran brand with standard logo. Intervention 3: Control group: For the control group, 3 cups of water per day more than last daily consumption will be recommended. Yes - There is a plan to make this available What will be shared: All data, protocols and forms of conscious consent can be shared (after individuals have been unrecognizable), . When: Start the access period 6 months after printing the results To whom: It will only be available to researchers working in academic and scientific institutions. Conditions: No analysis should be performed on the data. Where to obtain: Email: m.shayestefar@semums.ac.ir Mina Shayestehfar - Faculty Member of Semnan University of Medical Sciences How to obtain: After reviewing the application and 6 months have passed since the results were published, the data will be sent within a week if the application of results are confirmed for the applicant. Comments:
public Mina Shayestefar
Semnan University of Medical Sciences, Basij Blvd, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 m.shayestefar@semums.ac.ir Semnan University of Medical Sciences scientific Mina Shayestefar
Taavon street- first west 16 th- Fotros- 2th unit
Semnan Iran (Islamic Republic of) 3514774913 +98 23 3345 0193 m.shayestefar@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Satisfaction to participate in the study Existence driver's health record Metabolic syndrome based on ATP definition Age range 40 to 50 years 40 years 50 years Both A history of gastrointestinal disease A history of liver disease Being treated with corticosteroid drugs E88.81 Metabolic syndrome Treatment - Other Treatment - Other N/A First intervention group: Green Tea- To the Green Tea Group will be recommended 3 cups of simple green teabag (one gram) daily from without added sugar or milk for 2 months. There will be provided from hygienic packaging products from Golestan brand with standard logo. Second intervention group: Wheat bran- To the wheat bran group will be recommended 3.5 gram wheat bran powder based on individual taste with yogurt or rice daily for 2 months. There will be provided from hygienic packaging products of Nan Avaran brand with standard logo. Control group: For the control group, 3 cups of water per day more than last daily consumption will be recommended. Height. Timepoint: The measurement will be performed at baseline and before the intervention. Method of measurement: By the meter. Weight. Timepoint: Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention. Method of measurement: By a balance scales. Systolic & Diastolic pressure. Timepoint: Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention. Method of measurement: By a Sphygmomanometer. Abdominal circumference. Timepoint: Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention. Method of measurement: By a meter. Fasting Blood Sugar. Timepoint: Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention. Method of measurement: By a Micro-plate Eliza Reader with Parsazmun kits. Triglycerides. Timepoint: Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention. Method of measurement: By a Micro-plate Eliza Reader with Parsazmun kits. High Density Lipoprotein. Timepoint: Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention. Method of measurement: By a Micro-plate Eliza Reader with Parsazmun kits. Semnan University of Medical Sciences Approved 2020-02-04 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Avenue Semnan Semnan Iran (Islamic Republic of)