NCT07763626Completed
Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD
Efficacy of a Brown Algae-Based Nutraceutical Combined With a Hypocaloric Mediterranean Diet on Metabolic Dysfunction in Hepatic Steatosis: The Gdue Study
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 8 Aug 2026
- Start date
- 1 Sept 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- University of Genova
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07763626
What you commit to
- Study type: Interventional
- Participants enrolled: 112
- From 1 Sept 2023 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cancer. Chronic inflammatory diseases, including rheumatic or infectious disorders. Psychiatric disorders. Severe cardiovascular or cerebrovascular disease. New York Heart Association class II-IV heart failure. Prior myocardial infarction or stroke. Cerebrovascular event within the 6 months before enrollment.
Lab values
- Alcohol consumption \>20 g/day in women or \>30 g/day in men. Use of nutraceutical supplements within the previous 6 months. Use of anti-obesity pharmacological treatment within the previous 6 months. Renal insufficiency, defined as serum creatinine above the upper limit of the reference range.
Criteria the registry did not label
- IInclusion Criteria:
- Age 18 years or older. Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD).
- Metabolic syndrome according to International Diabetes Federation criteria, defined as central adiposity (waist circumference ≥94 cm in men and ≥80 cm in women) plus at least two of the following:
- Triglycerides \>150 mg/dL. HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women. Systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg, or ongoing antihypertensive treatment.
- Fasting plasma glucose 110-125 mg/dL or established type 2 diabetes mellitus. Moderate-to-severe hepatic steatosis at baseline, defined as steatosis grade S2 or S3 according to Controlled Attenuation Parameter assessment.
- Ability to understand the study procedures and provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Genoa Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.