Metabolic Dysfunction-Associated Steatotic Liver DiseaseGDUENCT07763626
Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD
A study testing Brown Algae and Chromium Picolinate Supplement in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Syndrome, run by University of Genova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome
- What is being tested?
- Brown Algae and Chromium Picolinate Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Brown Algae-Based Nutraceutical Combined With a Hypocaloric Mediterranean Diet on Metabolic Dysfunction in Hepatic Steatosis: The Gdue Study
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.
Read the detailed description
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.
- Being tested
- Brown Algae and Chromium Picolinate Supplement, Matching Placebo (B)
- 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
- Medical subject headings
- Metabolic Syndrome, Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brown Algae and Chromium Picolinate SupplementDietary supplement
Also called Gdue®
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Matching Placebo (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months (180 ± 5 days)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Pisciotta, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763626
- Sponsor's protocol ID
- GDUE
- Acronym
- GDUE
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brown Algae-Based Nutraceutical Combined With a Hypocaloric Mediterranean Diet on Metabolic Dysfunction in Hepatic Steatosis: The Gdue Study
- ClinicalTrials.gov ID
- NCT07763626
- Acronym / sponsor ID
- GDUE / GDUE
- Keywords
- MASLD, Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatic Steatosis, Metabolic Syndrome, Hypocaloric Mediterranean Diet, Ascophyllum nodosum, Fucus vesiculosus, Nutraceutical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gdue® Plus Hypocaloric Mediterranean Diet | Experimental | Dietary Supplement: Brown Algae and Chromium Picolinate SupplementParticipants 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. |
| Placebo Plus Hypocaloric Mediterranean Diet | Placebo comparator | Dietary Supplement: Matching Placebo (B)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brown Algae and Chromium Picolinate SupplementAlso: Gdue®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 | Gdue® Plus Hypocaloric Mediterranean Diet |
| 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. | Dietary supplement | Placebo Plus Hypocaloric Mediterranean Diet |
Primary outcome
Change From Baseline in Controlled Attenuation Parameter
Time frame: Baseline and 6 months (180 ± 5 days)
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.
3 secondary outcomes
Change From Baseline in Body Mass Index
Time frame: Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)
Change From Baseline 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
Time frame: Baseline, 3 months (90 ± 5 days), and 6 months (180 ± 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brown Algae and Chromium Picolinate Supplement in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Syndrome, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Controlled Attenuation Parameter (time frame: Baseline and 6 months (180 ± 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.