Assessment of the Safety and Effectiveness of a Specialized Food Product in Obese Children Aged 6-9 Years

Effective dietary interventions using specialized food products are needed to reduce inflammation in obese children. This study evaluated the safety and effectiveness of a lyophilized colostrum serum product, “Immunocol LP”, in children aged 6–9 years with obesity.

Materials and methods. A prospective single-center study included 80 children (BMI >2.0 SDS by WHO, 2009), divided into a main group and a control group (n = 40 each). The main group received one sachet (3 g) of “Immunocol LP” twice daily, 30 min before meals for 28 days. The following were assessed: serum CRP, LPS, ALT, total cholesterol, CBC, fecal calprotectin, short-chain fatty acids (SCFA), microbiota composition (PCR), anthropometry, and body composition (bioimpedance). Follow-up was performed two weeks after treatment.

Results. “Immunocol LP” intake led to a significant reduction in CRP (p = 0.004), LPS (p = 0.002), ALT (p = 0.040), and cholesterol (p = 0.027). Improvement in CBC and increased fecal SCFAs, including acetic (p = 0.030) and propionic acids (p = 0.037), were observed. Microbiota species composition remained unchanged. BMI, height, and body composition dynamics were similar in both groups.

Conclusion. “Immunocol LP” demonstrated anti-inflammatory effects by reducing systemic markers (CRP, LPS), lowering ALT, and stimulating SCFA production. It was well tolerated, with no adverse effects. These findings support the potential of “Immunocol LP” as an adjunct to dietary therapy in obese young children.

1. Spinelli A, Buoncristiano M, Nardone P, Starc G, Hejgaard T, Júlíusson PB, et al. Thinness, overweight, and obesity in 6-to 9-year-old children from 36 countries: The World Health Organization European Childhood Obesity Surveillance Initiative-COSI 2015–2017. Obesity Reviews. 2021;22(Suppl 6):e13214. DOI: https://doi.org/10.1111/obr.13214.

2. Gates A, Elliott SA, Shulhan-Kilroy J, Ball GDC, Hartling L. Effectiveness and safety of interventions to manage childhood overweight and obesity: An Overview of Cochrane systematic reviews. Paediatrics & Child Health. 2021;26(5):310–316. DOI: https://doi.org/10.1093/pch/pxaa085.

3. Podchinenova DV, Samoilova YG, Kobyakova OS, Koshmeleva MV, Oleynik OA. Optimization of the algorithm for prevention and early diagnosis of metabolic syndrome and its predictors. Ural Medical Journal. 2019;(12):41–46. (In Russ.). EDN: https://www.elibrary.ru/LFBPVL.

4. Tarabrina AA, Samoilova YG, Oleynik OA, Matveeva MV, Subordenov DV, Diraeva NM, et al. Visceral obesity as a new area of research on mechanisms triggering allergic inflammation in children. Cardiovascular Therapy and Prevention. 2023;22(S6):32. (In Russ.). EDN: https://www.elibrary.ru/BGKXKD.

5. Konishcheva AY, Lysogora VA, Gervazieva VB. The inflammatory patterns in patients with bronchial asthma and concomitant obesity. Russian Journal of Immunology. 2017;11(3):390–393. EDN: https://www.elibrary.ru/ZFXBJV.

6. Ferrante AW Jr. Obesity-induced inflammation: a metabolic dialogue in the language of inflammation. Journal of Internal Medicine. 2007;262(4):408–414. DOI: https://doi.org/10.1111/j.1365-2796.2007.01852.x.

7. Aboeldalyl S, James C, Seyam E, Ibrahim EM, Shawki HED, Amer S. The role of chronic inflammation in polycystic ovarian syndrome — a systematic review and meta-analysis. International Journal of Molecular Sciences. 2021;22(5):2734. DOI: https://doi.org/10.3390/ijms22052734.

8. Lainez NM, Coss D. Obesity, neuroinflammation, and reproductive function. Endocrinology. 2019; 160(11):2719–2736. DOI: https://doi.org/10.1210/en.2019-00487.

9. Vetrani C, Di Nisio A, Paschou SA, Barrea L, Muscogiuri G, Graziadio C, et al. From gut microbiota through low-grade inflammation to obesity: Key players and potential targets. Nutrients. 2022;14(10):2103. DOI: https://doi.org/10.3390/nu14102103.

10. Liébana-García R, Olivares M, Bullich-Vilarrubias C, López-Almela I, Romaní-Pérez M, Sanz Y. The gut microbiota as a versatile immunomodulator in obesity and associated metabolic disorders. Best Practice & Research Clinical Endocrinology & Metabolism. 2021;35(3):101542. DOI: https://doi.org/10.1016/j.beem.2021.101542.

11. Harris K, Kassis A, Major G, Chou CJ. Is the gut microbiota a new factor contributing to obesity and its metabolic disorders? Journal of Obesity. 2012;2012:879151. DOI: https://doi.org/10.1155/2012/879151.

12. Wang J, Chen WD, Wang YD. The relationship between gut microbiota and inflammatory diseases: The role of macrophages. Frontiers in Microbiology. 2020;11:1065. DOI: https://doi.org/10.3389/fmicb.2020.01065.

13. Sun L, Ma L, Ma Y, Zhang F, Zhao C, Nie Y. Insights into the role of gut microbiota in obesity: Pathogenesis, mechanisms, and therapeutic perspectives. Protein & Cell. 2018;9(5):397–403. DOI: https://doi.org/10.1007/s13238-018-0546-3.

14. Newman NK, Zhang Y, Padiadpu J, Miranda CL, Magana AA, Wong CP, et al. Reducing gut microbiome-driven adipose tissue inflammation alleviates metabolic syndrome. Microbiome. 2023;11(1):208. DOI: https://doi.org/10.1186/s40168-023-01637-4.

15. ElSayed HL, Abdelsayed MGR, Emara ISA. Effect of lactoferrin supplementation on appetite and weight loss in obese school age children. QJM: An International Journal of Medicine. 2021;114(Suppl_1): hcab113.029. DOI: https://doi.org/10.1093/qjmed/hcab113.029.

16. Miyakawa M, Oda H, Tanaka M. Clinical research review: Usefulness of bovine lactoferrin in child health. BioMetals. 2023;36(3):473–489. DOI: https://doi.org/10.1007/s10534-022-00430-4.

17. de Onis M, Garza C, Victora CG, Onyango AW, Frongillo EA, Martines J. The WHO Multicentre Growth Reference Study: Planning, study design, and methodology. Food and Nutrition Bulletin. 2004;25(1 Suppl): S15–S26. DOI: https://doi.org/10.1177/15648265040251S104.

18. Gifford JL, Hunter HN, Vogel HJ. Lactoferricin: A lactoferrin-derived peptide with antimicrobial, antiviral, antitumor and immunological properties. Cellular and Molecular Life Sciences. 2005;62(22):2588–2598. DOI: https://doi.org/10.1007/s00018-005-5373-z.

19. Zhang L, Rozek A, Hancock REW. Interaction of cationic antimicrobial peptides with model membranes. The Journal of Biological Chemistry. 2001;276(38):35714–35722. DOI: https://doi.org/10.1074/jbc.M104925200.

20. Drago-Serrano ME, De La Garza-Amaya M, Luna JS, Campos-Rodríguez R. Lactoferrin-lipopolysaccharide (LPS) binding as key to antibacterial and antiendotoxic effects. International Immunopharmacology. 2012; 12(1):1–9. DOI: https://doi.org/10.1016/j.intimp.2011.11.002.

21. Connell S, Kawashima M, Nakamura S, Imada T, Yamamoto H, Tsubota K, et al. Lactoferrin ameliorates dry eye disease potentially through enhancement of short-chain fatty acid production by gut microbiota in mice. International Journal of Molecular Sciences. 2021;22(22):12384. DOI: https://doi.org/10.3390/ijms222212384.

22. Portincasa P, Bonfrate L, Khalil M, Angelis MD, Calabrese FM, D’Amato M, et al. Intestinal barrier and permeability in health, obesity and NAFLD. Biomedicines. 2021;10(1):83. DOI: https://doi.org/10.3390/biomedicines10010083.

23. Hartman C, Rennert HS, Rennert G, Elenberg Y, Zuckerman E. Prevalence of elevated liver enzymes and comorbidities in children and adolescents with overweight and obesity. Acta Paediatrica. 2021;110(3):985–992. DOI: https://doi.org/10.1111/apa.15469.

24. Valle-Martos R, Jiménez-Reina L, Cañete R, Martos R, Valle M, Cañete MD. Changes in liver enzymes are associated with changes in insulin resistance, inflammatory biomarkers and leptin in prepubertal children with obesity. Italian Journal of Pediatrics. 2023;49(1):29. DOI: https://doi.org/10.1186/s13052-023-01434-7.

25. Nixdorf L, Hartl L, Ströhl S, Felsenreich DM, Mairinger M, Jedamzik J, et al. Rapid improvement of hepatic steatosis and liver stiffness after metabolic/bariatric surgery: A prospective study. Scientific Reports. 2024; 14(1):17558. DOI: https://doi.org/10.1038/s41598-024-67415-w.