Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD

NCT07763626 | Completed

• 1 other identifier: GDUE
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Syndrome

Keywords

MASLD; Metabolic Dysfunction-Associated Steatotic Liver Disease; Hepatic Steatosis; Metabolic Syndrome; Hypocaloric Mediterranean Diet; Ascophyllum nodosum; Fucus vesiculosus; Nutraceutical; Controlled Attenuation Parameter; Insulin Resistance; Body Composition

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Controlled Attenuation Parameter

  Hepatic steatosis was quantitatively assessed using the Controlled Attenuation Parameter (CAP) obtained by FibroScan® and expressed in decibels per meter (dB/m). The outcome was calculated as the CAP value at 6 months minus the CAP value at baseline. Negative values indicate a reduction in hepatic steatosis, while positive values indicate an increase.

  Baseline and 6 months (180 ± 5 days)

Secondary Outcomes (3)

• Change From Baseline in Body Mass Index

  Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)

• Change From Baseline in Waist Circumference

  Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)

• Change From Baseline in Homeostasis Model Assessment of Insulin Resistance

  Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)

Study Arms (2)

Gdue® Plus Hypocaloric Mediterranean Diet

EXPERIMENTAL

Participants received Gdue® orally, one capsule three times daily approximately 30 minutes before the main meals, for 6 months. Each capsule contained 237.5 mg of Ascophyllum nodosum, 12.5 mg of Fucus vesiculosus, and 7.5 µg of chromium picolinate. Participants also received an individualized hypocaloric Mediterranean diet, physical activity counseling, and advice to avoid alcohol consumption.

Dietary Supplement: Brown Algae and Chromium Picolinate Supplement

Placebo Plus Hypocaloric Mediterranean Diet

PLACEBO COMPARATOR

Participants received a matching placebo orally, one capsule three times daily approximately 30 minutes before the main meals, for 6 months. The placebo was provided in a dosage form and packaging indistinguishable from Gdue®. Participants also received the same individualized hypocaloric Mediterranean diet, physical activity counseling, and advice to avoid alcohol consumption.

Dietary Supplement: Matching Placebo (B)

Interventions

Brown Algae and Chromium Picolinate Supplement DIETARY_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.

Also known as: Gdue®

Gdue® Plus Hypocaloric Mediterranean Diet

Matching Placebo (B) DIETARY_SUPPLEMENT

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.

Placebo Plus Hypocaloric Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

University of Genoa

Genova, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome; Fatty Liver; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators involved in data collection were masked to treatment allocation. Gdue® and placebo were provided in indistinguishable dosage forms and identical packaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Participants were assigned in a 1:1 ratio to two parallel groups receiving either Gdue® or matching placebo, both combined with an individualized hypocaloric Mediterranean diet, for 6 months.

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: September 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)