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Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD
Sponsor: University of Genova
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.
Official title: Efficacy of a Brown Algae-Based Nutraceutical Combined With a Hypocaloric Mediterranean Diet on Metabolic Dysfunction in Hepatic Steatosis: The Gdue Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2023-09-01
Completion Date
2025-07-31
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
Brown Algae and Chromium Picolinate Supplement
Oral dietary supplement containing 237.5 mg of Ascophyllum nodosum, 12.5 mg of Fucus vesiculosus, and 7.5 µg of chromium picolinate per capsule. Participants took one capsule three times daily, approximately 30 minutes before the main meals, for 6 months. Treatment adherence was assessed at follow-up visits by pill count and collection of unused capsules.
Matching Placebo (B)
Matching placebo provided in a dosage form and packaging indistinguishable from the active dietary supplement. Participants took one capsule three times daily, approximately 30 minutes before the main meals, for 6 months. Treatment adherence was assessed at follow-up visits by pill count and collection of unused capsules.
Locations (1)
University of Genoa
Genova, Italy