Rondanelli Mariangela, Perna Simone, Porta Matteo Della, Lombardoni Federico, Patelli Zaira, Nichetti Mara, Gasparri Clara, Pistolesi Elvira, Cestaro Benvenuto, Cazzola Roberta
Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, 27100, Italy.
Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milano, Milano, 20133, Italy.
BMC Nutr. 2025 Sep 2;11(1):170. doi: 10.1186/s40795-025-01153-8.
Up to now, scientific literature has not reported studies evaluating the efficacy of polyglucosamine L112 on body weight, insulin resistance, and cholesterol levels in patients with metabolic syndrome, despite its known antioxidant properties and potential to reduce these parameters, making it a promising candidate for treating metabolic syndrome.
The aim of this study was to examine the activity of L112 in a subgroup of cases suffering from metabolic syndrome (MS).
A subgroup of 26 subjects (8 males and 18 females; age 55 ± 11.3 years; BMI 31.1 ± 1.35 kg/m²) was selected from a previous larger RCT study and statistically analyzed. Among them, 12 subjects were administered a diet and placebo, while 14 were administered a diet and L112 at a dosage of 3 g/day.
In the placebo group, 3 out of 12 cases (25%) showed resolution of metabolic syndrome (MS), whereas in the L112 group, 7 out of 14 cases (50%) showed resolution. Differences were statistically significant (Fisher χp < 0.01). L112 was more effective than placebo on the reduction of BMI, BW, insulin resistance, visceral adipose tissue (VAT), and fat mass (FM). No modification of fat-soluble vitamins (Vit A, E, D3, K1) and glucosamine levels was shown.
Despite a relatively short period of administration (3 months), L112 was found to reduce MS in 50% of the cases, acting as a safe medical device as a single daily treatment.
Current Controlled Trials NCT04375696, 20/12/2021 (https//clinicaltrials.gov/study/NCT04375696), "Retrospectively registered".
尽管聚葡萄糖胺L112具有已知的抗氧化特性以及降低体重、胰岛素抵抗和胆固醇水平的潜力，使其成为治疗代谢综合征的有前景的候选药物，但迄今为止，科学文献尚未报道评估聚葡萄糖胺L112对代谢综合征患者体重、胰岛素抵抗和胆固醇水平疗效的研究。
本研究的目的是检查L112在一组患有代谢综合征（MS）的病例中的活性。
从先前一项更大规模的随机对照试验研究中选取了26名受试者（8名男性和18名女性；年龄55±11.3岁；体重指数31.1±1.35kg/m²）的亚组进行统计分析。其中，12名受试者接受饮食和安慰剂治疗，而14名受试者接受饮食和每日3g剂量的L112治疗。
在安慰剂组中，12例中有3例（25%）代谢综合征（MS）得到缓解，而在L112组中，14例中有7例（50%）得到缓解。差异具有统计学意义（Fisher χp<0.01）。L112在降低体重指数、体重、胰岛素抵抗、内脏脂肪组织（VAT）和脂肪量（FM）方面比安慰剂更有效。未显示脂溶性维生素（维生素A、E、D3、K1）和葡萄糖胺水平有变化。
尽管给药期相对较短（3个月），但发现L112在50%的病例中可减轻MS，作为每日单次治疗是一种安全的医疗手段。
当前受控试验NCT04375696，2021年12月20日（https//clinicaltrials.gov/study/NCT04375696），“回顾性注册”
