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Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD

NCT07763626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • University of Genova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763626 on ClinicalTrials.gov