]>
IRCT20181111041611N6 IRCT 2022-11-28 Kermanshah University of Medical Sciences A Comparative study of the effect of anti-inflammatory diet and barberry intake on non-alcoholic fatty liver status of children A comparative study the effect of anti-inflammatory diet and Barberry intake on liver fat accumulation, anthropometric and biochemical indices in 8-13 year obese and overweight children with non alcoholic fatty liver 2022-11-16 anticipated 48 Complete https://irct.ir/trial/66860 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used to ensure that exactly the same number of participants enter the groups in a consecutive but equal time interval. At first, based on the sample size, we evaluate all possible states (permutations) of block formation, so that based on the sample size (48 people), 8 blocks of six will be produced. In each block, 6 of the three groups A, B, C (group A: intake of anti-inflammatory diet, group B: intake of barberry, group C: intake of barberry and anti-inflammatory diet) will be included twice. The blocks are produced by the statistics consultant and the envelope will be used to hide the blocks. We will assign people to three groups according to the group names in the blocks. Each of the blocks is numbered and will be used, that is, if block number 1 (for example, ABCABC) is selected by lottery, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment C, the fourth patient will receive treatment A, and the fifth patient will receive treatment B. The sixth patient will take C. For the 7th patient and onward, I consider one of the previously specified blocks by random drawing again, and for assigning people to groups, we consider the sequence of this block as the same as the first block. One of the potential problems in the blocking method is the disclosure of the last allocation in each block. This problem occurs when the study uses the blocking method with fixed blocks, which is not used in this study. Rather, the blocks are randomly selected. Software and sites also generate this block random sequence, such as: www.randomization.com www.sealedenvelope.com. N/A Obesity. Intervention 1: Intervention group: including weight maintenance and anti-inflammatory diet along with intaking 3 grams of barberry before meals (Weight maintenance and anti-inflammatory diet containing 18% protein, 30% fat and 52% carbohydrates, consisting of lean meats, chicken, fish, omega-3 sources, special sources of carbohydrates, colored fruits and vegetables, nuts and legumes, fresh yogurt, products It is rich in special probiotics and honey and eliminates inflammatory foods such as high-fat foods, sugar and simple sugars, fast food and processed meats (sausages, sausages, etc.)). Intervention 2: Intervention group: It includes taking 3 grams of barberry before meals. Intervention 3: Intervention group: including Weight maintenance and anti-inflammatory diet containing 18% protein, 30% fat and 52% carbohydrates, consisting of lean meats, chicken, fish, omega-3 sources, special sources of carbohydrates, colored fruits and vegetables, nuts and legumes, fresh yogurt, products It is rich in special probiotics and honey and eliminates inflammatory foods such as high-fat foods, sugar and simple sugars, fast food and processed meats (sausages, sausages, etc.). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mehnoosh Samadi
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3710 2009 mehnoosh_samadi@yahoo.com Kermanshah University of Medical Sciences scientific Mehnoosh Samadi
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3710 2009 mehnoosh_samadi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Placement in the age group of 8-13 years Body mass index (BMI) above the 85th percentile Lack of diabetes Lack of cardiovascular disease Lack of diabetes liver disease Lack of kidney disease Lack of diabetes thyroid disorder 8 years 13 years Both puberty Children of professional athletes Taking any supplements (vitamins, minerals, etc.) The presence of digestive problems E66 Overweight and obesity Treatment - Other Treatment - Other Treatment - Other Intervention group: including weight maintenance and anti-inflammatory diet along with intaking 3 grams of barberry before meals (Weight maintenance and anti-inflammatory diet containing 18% protein, 30% fat and 52% carbohydrates, consisting of lean meats, chicken, fish, omega-3 sources, special sources of carbohydrates, colored fruits and vegetables, nuts and legumes, fresh yogurt, products It is rich in special probiotics and honey and eliminates inflammatory foods such as high-fat foods, sugar and simple sugars, fast food and processed meats (sausages, sausages, etc.)) Intervention group: It includes taking 3 grams of barberry before meals Intervention group: including Weight maintenance and anti-inflammatory diet containing 18% protein, 30% fat and 52% carbohydrates, consisting of lean meats, chicken, fish, omega-3 sources, special sources of carbohydrates, colored fruits and vegetables, nuts and legumes, fresh yogurt, products It is rich in special probiotics and honey and eliminates inflammatory foods such as high-fat foods, sugar and simple sugars, fast food and processed meats (sausages, sausages, etc.) Liver fat status. Timepoint: Before the start of the study, 12 weeks after the start of the intervention. Method of measurement: Liver fat will be measured using ultrasound and biochemical indicators and lipid profile from a blood test. Kermanshah University of Medical Sciences Approved 2022-10-11 Ethics Committee of Kermanshah University of Medical Sciences Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran کرمانشاه Kermanshah Iran (Islamic Republic of)