Background and Aim Metabolic dysfunction–associated steatotic liver disease (MASLD) is a clinical condition closely associated with obesity, insulin resistance, and metabolic syndrome. Since no pharmacological therapy is currently available to counteract MASLD, therapeutic strategies rely primarily on lifestyle modification, with dietary intervention and regular physical activity representing the cornerstone of disease management. However, the long-term adherence and effectiveness of lifestyle measures alone remain challenging, highlighting the need for complementary strategies capable of enhancing metabolic and hepatic outcomes within a nutritional framework. In this context, nutraceuticals are emerging as potential adjunctive strategies. Gdue®, a nutraceutical containing brown algae extracts (Ascophyllum nodosum and Fucus vesiculosus) combined with chromium picolinate, has shown promising metabolic and hepatic effects both in preclinical and clinical studies, including partial regression of hepatic steatosis and improvement in transaminases, insulinemia, HOMA-IR, glycemia, HDL-C, blood pressure and anthropometric parameters. A randomized, double-blind, placebo-controlled clinical trial was designed by the Department of Internal Medicine and Medical Sciences, University of Genoa in collaboration with the Unit of Dietetics and Clinical Nutrition (UOSD), IRCCS Policlinico San Martino. The aim of the study was to evaluate the effects of Gdue®, in combination with a hypocaloric diet, on hepatic steatosis and anthropometric parameters in patients with metabolic syndrome associated to MASLD. Methods From March 2023 to June 2025 a total of 101 patients with MASLD and metabolic syndrome were enrolled and randomly allocated into two parallel groups to receive either Gdue® or placebo for six months, alongside a personalized hypocaloric Mediterranean diet provided by qualified dietitian. Gdue® and placebo were self-administered three times daily, approximately 30 minutes before main meals. Anthropometric, hematochemical, and hepatic parameters were assessed at baseline, 3 months, and 6 months. In addition, assessments of hepatic steatosis using Fibroscan (CAP) and bioimpedance analysis (BIA) were performed at baseline and at the end of treatment (6 months). Descriptive analysis of continuous variables was expressed as median (IQR), given the non-normal distribution of the data. Patient characteristics at baseline were compared by Placebo and Gdue® groups using the Mann-Whitney U-test for continuous variables and the Pearson's chi-squared test for categorical variables. Changes from baseline in percentage (Δ) were calculated by comparing the baseline T0 and T6 median values. Statistical analyses were performed using the SPSS software ver. 23.0 Results Both groups showed improvements in weight-related parameters following dietary intervention. However, patients receiving Gdue® experienced a significantly greater reduction in BMI at 6 months compared with placebo (p = 0.049). Fat mass reduction was also significantly greater in the Gdue® group (p = 0.018). Fasting insulin levels decreased significantly at 3 months in the Gdue® group compared with placebo (p = 0.033), while HDL-cholesterol increased significantly after 6 months (p = 0.041). A greater reduction in hepatic steatosis, assessed by CAP values, was observed in the Gdue® group compared with placebo (p = 0.039). The treatment was well tolerated, with no serious adverse events reported. Discussion and Conclusion The findings of this doctoral research demonstrate that the integration of Gdue® into a structured dietary intervention provides additional benefits beyond diet alone, particularly with respect to anthropometric parameters, lipid metabolism, and hepatic steatosis, while maintaining an excellent safety profile. Both treatment arms experienced significant improvements in body weight–related measures, underscoring the pivotal role of caloric restriction and diet quality as effective therapeutic tools in MASLD. Nevertheless, patients receiving Gdue® supplementation exhibited a significantly greater reduction in BMI at six months compared with placebo. One of the most clinically meaningful outcomes of the present trial is the significant reduction in hepatic steatosis, assessed by the Controlled Attenuation Parameter (CAP) measured with FibroScan®. Patients treated with Gdue® showed a more pronounced reduction in liver fat content. This finding is particularly relevant given the central role of hepatic steatosis in MASLD pathogenesis and progression. The favorable hepatic effects observed in this study are consistent with preclinical evidence demonstrating reduced lipid accumulation and modulation of lipogenic pathways in experimental models treated with Gdue®. Collectively, these data support a biological plausibility for the observed clinical benefits, likely mediated by the combined actions of polyphenols and other bioactive compounds present in brown algae extracts. These findings contribute to the growing evidence supporting nutraceuticals as valuable adjuncts in the nutritional management of metabolic liver disease and provide a rationale for further large-scale, long-term clinical investigations.
Efficacy of a Brown Algae–Based Nutraceutical Combined with the Mediterranean Diet on Metabolic Dysfunction in Hepatic Steatosis: The Gdue® Study
PROIETTI, ELISA
2026-05-25
Abstract
Background and Aim Metabolic dysfunction–associated steatotic liver disease (MASLD) is a clinical condition closely associated with obesity, insulin resistance, and metabolic syndrome. Since no pharmacological therapy is currently available to counteract MASLD, therapeutic strategies rely primarily on lifestyle modification, with dietary intervention and regular physical activity representing the cornerstone of disease management. However, the long-term adherence and effectiveness of lifestyle measures alone remain challenging, highlighting the need for complementary strategies capable of enhancing metabolic and hepatic outcomes within a nutritional framework. In this context, nutraceuticals are emerging as potential adjunctive strategies. Gdue®, a nutraceutical containing brown algae extracts (Ascophyllum nodosum and Fucus vesiculosus) combined with chromium picolinate, has shown promising metabolic and hepatic effects both in preclinical and clinical studies, including partial regression of hepatic steatosis and improvement in transaminases, insulinemia, HOMA-IR, glycemia, HDL-C, blood pressure and anthropometric parameters. A randomized, double-blind, placebo-controlled clinical trial was designed by the Department of Internal Medicine and Medical Sciences, University of Genoa in collaboration with the Unit of Dietetics and Clinical Nutrition (UOSD), IRCCS Policlinico San Martino. The aim of the study was to evaluate the effects of Gdue®, in combination with a hypocaloric diet, on hepatic steatosis and anthropometric parameters in patients with metabolic syndrome associated to MASLD. Methods From March 2023 to June 2025 a total of 101 patients with MASLD and metabolic syndrome were enrolled and randomly allocated into two parallel groups to receive either Gdue® or placebo for six months, alongside a personalized hypocaloric Mediterranean diet provided by qualified dietitian. Gdue® and placebo were self-administered three times daily, approximately 30 minutes before main meals. Anthropometric, hematochemical, and hepatic parameters were assessed at baseline, 3 months, and 6 months. In addition, assessments of hepatic steatosis using Fibroscan (CAP) and bioimpedance analysis (BIA) were performed at baseline and at the end of treatment (6 months). Descriptive analysis of continuous variables was expressed as median (IQR), given the non-normal distribution of the data. Patient characteristics at baseline were compared by Placebo and Gdue® groups using the Mann-Whitney U-test for continuous variables and the Pearson's chi-squared test for categorical variables. Changes from baseline in percentage (Δ) were calculated by comparing the baseline T0 and T6 median values. Statistical analyses were performed using the SPSS software ver. 23.0 Results Both groups showed improvements in weight-related parameters following dietary intervention. However, patients receiving Gdue® experienced a significantly greater reduction in BMI at 6 months compared with placebo (p = 0.049). Fat mass reduction was also significantly greater in the Gdue® group (p = 0.018). Fasting insulin levels decreased significantly at 3 months in the Gdue® group compared with placebo (p = 0.033), while HDL-cholesterol increased significantly after 6 months (p = 0.041). A greater reduction in hepatic steatosis, assessed by CAP values, was observed in the Gdue® group compared with placebo (p = 0.039). The treatment was well tolerated, with no serious adverse events reported. Discussion and Conclusion The findings of this doctoral research demonstrate that the integration of Gdue® into a structured dietary intervention provides additional benefits beyond diet alone, particularly with respect to anthropometric parameters, lipid metabolism, and hepatic steatosis, while maintaining an excellent safety profile. Both treatment arms experienced significant improvements in body weight–related measures, underscoring the pivotal role of caloric restriction and diet quality as effective therapeutic tools in MASLD. Nevertheless, patients receiving Gdue® supplementation exhibited a significantly greater reduction in BMI at six months compared with placebo. One of the most clinically meaningful outcomes of the present trial is the significant reduction in hepatic steatosis, assessed by the Controlled Attenuation Parameter (CAP) measured with FibroScan®. Patients treated with Gdue® showed a more pronounced reduction in liver fat content. This finding is particularly relevant given the central role of hepatic steatosis in MASLD pathogenesis and progression. The favorable hepatic effects observed in this study are consistent with preclinical evidence demonstrating reduced lipid accumulation and modulation of lipogenic pathways in experimental models treated with Gdue®. Collectively, these data support a biological plausibility for the observed clinical benefits, likely mediated by the combined actions of polyphenols and other bioactive compounds present in brown algae extracts. These findings contribute to the growing evidence supporting nutraceuticals as valuable adjuncts in the nutritional management of metabolic liver disease and provide a rationale for further large-scale, long-term clinical investigations.
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