Modification of metabolic syndrome parameters following the administration of polyglucosamine L112: results of a subgroup analysis of subjects enrolled in a double blind randomised placebo controlled clinical investigation

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 χ2p < 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". To date, no study has been conducted to evaluate the efficacy of polyglucosamine L112 on body weight, insulin resistance, and cholesterol in patients with metabolic syndrome, although the activities of polyglucosamine (antioxidant and reduction of BW, insulin resistance, and cholesterol levels) make this medical device an ideal candidate for the treatment of metabolic syndrome. Given this background, the aim of the present investigation is to analyze the activity of L112 versus placebo on body weight, insulin resistance, and cholesterol levels in a group of patients suffering from MS according to ATP III [1].