A Brief, Structured Online Nutritional Education Program is Effective in the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease Management: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- intrahepatic fat
Study Overview
Brief Summary
Study Summary Title: Mediterranean Diet Intervention for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomized Controlled Trial (The TIMA Study)
Introduction:
This trial, known as the TIMA (Taiwanese Mediterranean dietary intervention for MASLD) study, evaluated the clinical impact of a culturally adapted, online nutritional program.
Aims:
- Primary Aim: Assess the impact of an iso-calorie Mediterranean diet compared to standard care on intrahepatic fat in MASLD patients.
- Secondary Aims: Evaluate the effects on liver function tests, lipid profiles, HbA1c and insulin resistance (homeostatic model assessment of insulin resistance; HOMA-IR), noninvasive assessment of hepatic fibrosis with transient elastography by Fibroscan, Framingham Risk Score (FRS), serum metabolites, quality of life (QoL), compliance and stool microbiome.
Study Design:
- Type: 12-week, prospective, two parallel-group, randomized controlled trial.
- Participants: MASLD patients with >5% hepatic steatosis diagnosed by MRI-PDFF, randomized into two groups: Mediterranean diet intervention and standard care.
Randomization:
- Method: Computer-generated random numbers, 1:1 allocation.
- Blinding: Radiologists and statisticians blinded to treatment assignment.
Intervention:
- Mediterranean Diet Group: Specific dietary guidelines provided.
- Standard Care Group: Simple lifestyle advice.
Compliance:
• Monitored through standardized questionnaires and T-MEDAS at each visit.
Assessments:
Reduction of hepatic triglyceride content by MRI-PDFF at baseline and week 12.
Conclusion: This trial aims to determine the effectiveness of a Mediterranean diet in reducing intrahepatic fat and improving related metabolic and microbiome parameters in MASLD patients compared to standard care.
Detailed Description
Subject selection
a. Screening of potential subjects at the out-patient clinic Consecutive patients attending the hepatology of the Taichung Veterans General Hospital will be screened. Patients with features of fatty liver on ultrasound scan (bright echotexture, reduced ultrasound penetrance, and blurred vascular markings), magnetic resonance imaging will be screened after signing informed written consent. The screening procedure is described in section Screening.
Randomization Subjects meeting the inclusion and exclusion criteria will be randomized (1:1) to participate in an iso-calorie Mediterranean diet (MD) intervention or to receive simple lifestyle advice alone. Randomization is carried out through the use of computer-generated list of random numbers. Treatment assignment will be revealed in sealed envelopes.
Trial treatments
- Blinding Radiologists who evaluate the magnetic resonance image and physicians doing transient elastography by Fibroscan will be blinded to the treatment assignment.
- Dietary intervention program
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Radiologists who evaluate the magnetic resonance images, physicians performing transient elastography using Fibroscan, and statisticians analysing the final results will be blinded to the treatment assignments.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing to change diet for at least three months (accepting reduced sugar, less processed foods, reduced red meat, and following a Mediterranean diet with olive oil, high-fiber foods, vegetables, fruits, nuts, and legumes)
- •Intrahepatic triglyceride content (IHTG) of 5%
- •Age 18 to 70 years
- •Fulfill the diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
- •Baseline Mediterranean Diet Adherence Screener (T-MEDAS) score equal to or less than 5
- •Participants must not have initiated any new probiotic treatment in the past three months or must have been on a stable probiotic regimen for at least three months, which they are willing to continue for the duration of the study
Exclusion Criteria
- •Other liver disease (viral hepatitis, autoimmune or cholestatic liver disease, Wilson's disease, hemochromatosis, or alpha-1 anti-trypsin deficiency)
- •Unstable body weight (variation >5% within the preceding 3-month period)
- •Current use of weight loss medications (e.g., Liraglutide)
- •Current use of pioglitazone
- •Unstable diabetes (HbA1c >8.5%)
- •Decompensated cirrhosis (international normalized ratio >1.3, platelets <100 × 109/mm, bilirubin >20 mmol/L, albumin <35 g/L, ascites, or hepatic encephalopathy)
- •A serum creatinine level ≥ 2mg/dL
- •Presence of active cancer or undergoing chemotherapy either at present or in the prior three years
- •Major illness that might require hospitalization
- •Pregnancy or lactation for women
- •Participation in another trial
- •Chronic treatment with warfarin (given its interaction with vitamin K)
- •Being implanted with a pacemaker or platinum implant (due to inability to undergo magnetic resonance imaging included in the study design)
- •Alcohol consumption above 30 g per day in men or 20 g per day in women
Arms & Interventions
Mediterranean-diet intervention group
Dietitian-guided Nutritionist Education Process:
- Conduct online educational sessions at Weeks 0, 3, 6, and 9, lasting 10 to 15 minutes each.
- The ultimate goal is to increase the MEDAS score by more than five points within 12 weeks.
- After the initial education session, provide participants with a common Q and A sheet, online, based on the dietary advice given. Investigators also provide education materials, a food-group list specifying preferred choices and approximate numbers and size of servings to consume per day.
Intervention: Mediterranean-diet intervention group (Behavioral)
Standard care group
A 10-minute talk on the epidemiology of MASLD and balanced diet, resembling routine clinical practice.
Intervention: Standard care (Behavioral)
Outcomes
Primary Outcomes
intrahepatic fat
Time Frame: Week 0 and week 12
Change in intrahepatic fat by MRI at the end of week 12
Secondary Outcomes
- Level of HbA1c(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- HOMA-IR(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- Alanine Aminotransferase(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- hepatic fibrosis (elastography)(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- Compliance(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- intrahepatic fat(twelfth months after completion of the trial)
- Serum metabolites(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- Stool microbiome(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
- Quality of life (QoL)(Week 0 and week 12; At the sixth and twelfth months after completion of the trial)
Investigators
Ying-Cheng Lin
Attending Physician, Division of Gastroenterology, Principal Investigator, Clinical Professor
Taichung Veterans General Hospital