The effect of orlistat and resveratrol in the treatment of nonalcoholic fatty liver disease in overweight and obese children and adolescents

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and methods of the study.
Girls and boys aged 8 to 18 years.
Having a Z score of body mass index higher than 1 and less than 3 for age and sex.
High serum levels of liver enzymes Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) 1.5 times normal.
Has evidence of non-alcoholic steatohepatitis in ultrasonography with grade 2 and above and Controlled Attenuation Parameter (CAP) score more than 263.
Absences other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases? and inherited disorders affecting the liver (iron, copper, etc.).
No history of alcohol consumption or alcohol consumption more than 10 grams per day in women and more than 20 grams per day in men.
Do not take hepatotoxic drugs such as phenytoin, amoxifen, and lithium.
Absences celiac disease, diabetes, cardiovascular disease, lung disease, and kidney disease
No substance abuse, no chronic inflammatory disease, no history of cancer, no hormone therapy, no recent weight loss diet.
No history of gastrointestinal surgery.
No pregnancy or breastfeeding in women.
Do not consume St. John's wort, omega 3, coenzyme Q10, and carnitine.
Do not take medications or supplements that affect appetite, weight, or metabolism for at least 6 months before the study (such as medications that affect carbohydrate, protein, or fat metabolism, and medications that reduce or increase appetite or food intake, including herbal supplements).

Exclusion Criteria

Having any acute illness
The occurrence of any accident that affects a person's health.
Acceptance rate less than 80%
Immigration
Exclusion based on personal preference of participants or their parents
Changes in medications taken during the study period

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity index. Timepoint: Beginning and end of the study. Method of measurement: Liver ultrasound.;Serum Alanine Aminotransferase (ALT) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum Aspartate Aminotransferase (AST)levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.

Secondary Outcome Measures

Name	Time	Method
Serum Alkaline Phosphatase (ALP) Levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum leptin levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum adiponectin levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum hemoglobin A1c levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Weight. Timepoint: Beginning and end of the study. Method of measurement: scale.;Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Calculation.;Serum C-Reactive Protein (CRP) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum glucose levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Serum triglyceride level. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.