Abstract Disclosure: V. Antoniotti: None. V. Mancioppi: None. A. Solito: None. C. Partenope: None. A. Petri: None. I. Rabbone: None. L. Scotti: None. F. Prodam: None. Background: In the last decades, pediatric obesity and cardiovascular-associated risks have been relevant challenges. The first treatment against obesity is a lifestyle change, nevertheless, no intervention seems to be effective in the evolution of the condition, especially in the long term. Thus, the interest in non-pharmaceutical as well as pharmaceutical compounds is growing. Inositol compounds have recently been studied in adults with obesity and insulin resistance but have never been investigated in the pediatric age where insulin resistance is a specific trait of puberty. Furthermore, zinc is critical for insulin secretion and growth. Methods. This is a double-blind, randomized, placebo-controlled study aiming to explore the efficacy of 3 months of combined administration of Zinc (5 mg/die) and Myo-inositol (2000 mg/die) in children and adolescents with obesity. 56 patients aged 10- 17.9 years (starting from Tanner 3) with obesity and insulin resistance have been enrolled. The treatment group received 5 mg of Zinc, 2000 mg of Myo-inositol, and 1000 mg of galactooligosaccharides from Pisum sativum, while the placebo group only received 1000 mg of galactooligosaccharides from Pisum sativum. All patients were subjected to an isocaloric diet following the Mediterranean diet style consisting of 55% carbohydrates, 30-35% fat, and 15% protein. Clinical and biochemical evaluations were carried out for the determination of weight, lipid profile, liver function, and glucose-insulin metabolism. Results. At the end of the study, BMI, fasting insulin, and insulin resistance (HOMA-IR) were significantly improved in both groups, while the treatment group also had an increase in HDL cholesterol (p=0.0426). On the other hand, the placebo group significantly improved its eating habits showing greater adherence to the Mediterranean diet than the treatment group. Moreover, subjects were divided according to the degree of obesity. Fasting insulin (p= 0.0137), HOMA-IR (p= 0.0273), and systolic blood pressure (p= 0.0349) showed a significant improvement in treated patients with severe obesity compared to treated patients with low-grade obesity. Thus, subjects with a higher level of obesity respond better to both treatment and lifestyle change than those with a lower grade of obesity. Also, the improvement of the lifestyle and the presence of fiber allow an increase in the metabolic framework in placebo subjects. Conclusions. Supplementation with Zinc and Myo-inositol could be used as a non-pharmacological compound for the control of complications related to obesity also in the pediatric age. Presentation: 6/1/2024
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