An interventional study of Brown Algae and Chromium Picolinate Supplement and Matching Placebo (B) in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Syndrome, sponsored by University of Genova. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by University of Genova · Not applicable, Interventional, and Treatment
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.
This was a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted in adults with metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic syndrome, and moderate-to-severe hepatic steatosis.
Eligible participants were aged 18 years or older and had hepatic steatosis classified as grade S2 or S3 according to the controlled attenuation parameter (CAP), together with metabolic syndrome defined according to International Diabetes Federation criteria.
Participants were randomly assigned in a 1:1 ratio to one of two study groups:
Gdue® plus an individualized hypocaloric Mediterranean diet; or Matching placebo plus the same individualized hypocaloric Mediterranean diet.
Gdue® contained 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. The placebo was provided in an indistinguishable dosage form and identical packaging to maintain masking.
All participants received individualized dietary counseling from a qualified dietitian. The dietary intervention consisted of a hypocaloric Mediterranean diet with an estimated energy deficit of approximately 600 to 1,000 kcal per day relative to individual energy requirements. The diet emphasized minimally processed foods, vegetables, fruit, whole grains, legumes, fish, nuts, and extra-virgin olive oil, while limiting refined sugars, sweetened beverages, processed foods, and excess saturated fat. Participants also received counseling on physical activity and were advised to avoid alcohol during the study.
Clinical and biochemical assessments were performed at baseline, approximately 3 months, and approximately 6 months. Evaluations included body weight, body mass index, waist circumference, blood pressure, fasting glucose, glycated hemoglobin, fasting insulin, HOMA-IR, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, liver enzymes, homocysteine, and serum creatinine.
Body composition was assessed at baseline and 6 months using bioelectrical impedance analysis. Liver steatosis was assessed using CAP, and liver fibrosis was evaluated using vibration-controlled transient elastography at baseline and 6 months.
Adherence to the study product was assessed by pill count and collection of unused capsules. Adherence to the Mediterranean diet was evaluated using the 14-item Mediterranean Diet Adherence Screener. Adverse events and treatment tolerability were recorded throughout the study.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 112 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Genova is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
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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 .
Exclusion Criteria:
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. class II-IV heart failure. Prior myocardial infarction or stroke. Cerebrovascular event within the 6 months before enrollment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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®
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.
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.
Time frame: Baseline and 6 months (180 ± 5 days)
Change From Baseline in Body Mass Index
change from baseline was calculated as the value at each follow-up visit minus the baseline value. Negative values indicate a reduction in body mass index.
Time frame: Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)
Change From Baseline in Waist Circumference
Change from baseline was calculated as the follow-up value minus the baseline value. Negative values indicate a reduction in waist circumference.
Time frame: Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance
Change from baseline was calculated as the follow-up value minus the baseline value. Lower values indicate lower insulin resistance.
Time frame: Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable request, subject to approval of a scientifically sound proposal and compliance with applicable institutional, ethical, and data protection requirements.
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University of Genova