Efficacy of a Brown Algae-Based Nutraceutical Combined With a Hypocaloric Mediterranean Diet on Metabolic Dysfunction in Hepatic Steatosis: The Gdue Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Genova
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Controlled Attenuation Parameter
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Participants and investigators involved in data collection were masked to treatment allocation. Gdue® and placebo were provided in indistinguishable dosage forms and identical packaging.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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. New York Heart Association class II-IV heart failure. Prior myocardial infarction or stroke. Cerebrovascular event within the 6 months before enrollment.
Arms & Interventions
Gdue® Plus Hypocaloric Mediterranean Diet
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.
Intervention: Brown Algae and Chromium Picolinate Supplement (Dietary Supplement)
Placebo Plus Hypocaloric Mediterranean Diet
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.
Intervention: Matching Placebo (B) (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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))
Investigators
Livia Pisciotta
MD, PhD
University of Genova