Clinical Trial

Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD

Study acronym: GDUE
Completed
View on ClinicalTrials.gov →
Summary
This randomized, double-blind, placebo-controlled study evaluated whether Gdue®, a nutraceutical containing extracts of the brown algae Ascophyllum nodosum and Fucus vesiculosus together with chromium picolinate, could improve metabolic health and liver fat when added to a hypocaloric Mediterranean diet. Adults with metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic syndrome, and moderate-to-severe hepatic steatosis were randomly assigned to receive either Gdue® or a matching placebo for 6 months. All participants received an individualized hypocaloric Mediterranean diet and lifestyle counseling. Body weight, body mass index, waist circumference, blood pressure, blood glucose, insulin resistance, lipid levels, liver enzymes, body composition, and liver steatosis were assessed during the study. Liver steatosis was measured using the controlled attenuation parameter obtained by transient elastography. Safety, tolerability, treatment adherence, and adherence to the Mediterranean diet were also evaluated.
Trial Details
NCT Number NCT07763626
Lead Sponsor University of Genova
Conditions Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome
Enrollment 112 participants
Start Date 2023-09-01
Primary Completion 2025-07-31 (estimated)
Study Completion 2025-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-13