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

The effect of orlistat and resveratrol in the treatment of non-alcoholic fatty liver disease (NAFLD) in overweight and obese children and adolescents

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220409054467N2
Enrollment
90
Registered
2022-05-13
Start date
2022-04-21
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver. Alcoholic liver disease

Interventions

Intervention 1: Intervention group: People in intervention group will receive 150 mg of resveratrol supplement daily for 12 weeks. This supplements are provided by Karen Pharmaceuticals and Vital-Foo

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPejman Rohani

Tehran University of Medical Sciences

cmcpr@tums.ac.ir+98 21 6693 0024

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026