Gdue Plus a Hypocaloric Mediterranean Diet in Adults With MASLD

This was a single‐center, randomized, double‐blind, placebo‐controlled, parallel‐groupclinical trial conducted in adults with metabolic dysfunction‐associated steatotic liverdisease (MASLD), metabolic syndrome, and moderate‐to‐severe hepatic steatosis.Eligible participants were aged 18 years or older and had hepatic steatosis classified asgrade S2 or S3 according to the controlled attenuation parameter (CAP), together withmetabolic 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 thesame individualized hypocaloric Mediterranean diet.Gdue® contained 237.5 mg of Ascophyllum nodosum, 12.5 mg of Fucus vesiculosus, and 7.5 µgof 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 inan 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 estimatedenergy deficit of approximately 600 to 1,000 kcal per day relative to individual energyrequirements. The diet emphasized minimally processed foods, vegetables, fruit, wholegrains, legumes, fish, nuts, and extra‐virgin olive oil, while limiting refined sugars,sweetened beverages, processed foods, and excess saturated fat. Participants alsoreceived counseling on physical activity and were advised to avoid alcohol during thestudy.Clinical and biochemical assessments were performed at baseline, approximately 3 months,and approximately 6 months. Evaluations included body weight, body mass index, waistcircumference, blood pressure, fasting glucose, glycated hemoglobin, fasting insulin,HOMA‐IR, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, liverenzymes, homocysteine, and serum creatinine.Body composition was assessed at baseline and 6 months using bioelectrical impedanceanalysis. Liver steatosis was assessed using CAP, and liver fibrosis was evaluated usingvibration‐controlled transient elastography at baseline and 6 months.Adherence to the study product was assessed by pill count and collection of unusedcapsules. Adherence to the Mediterranean diet was evaluated using the 14‐itemMediterranean Diet Adherence Screener. Adverse events and treatment tolerability wererecorded throughout the study.