Evaluation of the adjactive effect of anti-inflammatory diet and ginger extract on liver fat grade, anthropometric and biochemical indices in 8-11 years obese children with non-alcoholic fatty liver

Evaluation of the adjactive effect of anti-inflammatory diet and ginger extract on liver fat grade, anthropometric and biochemical indices in 8-11 years obese children with non-alcoholic fatty liver.

This study was conducted in a clinical trial with a blinded double-blind, 164 obese children aged 11-8 years with fatty liver who will be randomly assigned to the control and intervention groups.

This study will be performed on 164 obese children aged 10-8 years with fatty liver In Mohammad Kermanshahi Hospital in 12 weeks. After explaining the objectives of the study and obtaining conscious consent, the subjects were evaluated for liver fat status, anthropometric and biochemical indicators. Liver fat will be measured by ultrasound, biochemical indicators and lipid profiles will be measured by blood test. Then individuals will be referred to control and intervention groups. Intervention group 1 Recommendation for Anti-Inflammatory Diet, Intervention group 2 includes daily consumption of 1 gram of ginger in capsules and in Group 3 includes following the anti-inflammatory diet with consumption of 1 g of ginger in form of capsules. In this study, the control group receives 1 gram of starch daily as a placebo.

Inclusion criteria: Age group of 8-10 years, lack of conditions such as diabetes, endocrine diseases and diseases of the cardiovascular system. Exclusion criteria: Professional sports and lack of supplements and vitamins.

Intervention 1 recommending an anti-inflammatory diet، Intervention 2 includes daily consumption of 1 gram of ginger in capsules and intervention 3 will include following an anti-inflammatory diet with 1 gram of ginger in capsules. In this study, the control group receives 1 gram of starch daily as a placebo.

The degree of fatty liver

Randomization method: stratified randomization  First, by attending the pediatrician's office, obese children with fatty liver with inclusion criteria will be selected, and 123 of them (three groups of 41 people) will be randomly selected for the intervention group and 41 for the control group. In order to unify the distorting variables, by using stratification for important variables, the distorting variables will enter the analysis of several variables. At first, the variables are divided into two groups of girls and boys and each group is based on the amount of physical activity divided into 3 groups: low, medium and severe. After separation based on physical activity, in the next step, the samples in each group will be divided into two categories based on calorie and macronutrient intake: low and high, and finally by Simple randomization, samples will be divided into four groups of intervention and control.

In this study, the researchers and participants will not be aware of the allocation of groups, and the supplements appearance will be similar in both groups. The supplemented manufacturer will encoded the supplements before delivery.During the study, the same conditions will be met, such as attending counseling sessions and how to test for all participants.

Trail that began to fall ill on 21th May of 2020 should have a release plan when recording its study protocol.