Feasibility of a web based hypocaloric Mediterranean diet intervention compared to standard care in individuals with non-alcoholic fatty liver disease (NAFLD).

Authors
Category Primary study
Registry of TrialsAustralian New Zealand Clinical Trials Register
Year 2021
INTERVENTION: The intervention will be a 12 week hypocaloric MedDiet using traditional MedDiet principles with the total energy targets altered to achieve a deficit of 750kJ per day. The diet will be prescribed by research dietitian(s). The diet will be rich in plant‐based foods including vegetables, whole grains and fruit with the main added fat being extra virgin olive oil. Emphasising increased legumes, raw unsalted nut intake and oily fish, with moderate fermented dairy and poultry and small amounts of red meat. Macronutrient distribution of 44% fat, 36% carbohydrate, 20% protein and up to 5% alcohol. The diet will be designed to be easy to follow and sustainable. The dietitian will tailor the diet to nutritionally appropriate, cultural and personal preferences. Dietary adherence will be monitored using a food diary and adherence questionnaires such as the MEDAS to monitor adherence to the Mediterranean Diet. Participants will access dietary resources using a web based platform. We will encourage to access this as regularly as they need and will collect data on frequency of access using website analytics. CONDITION: Metabolic and Endocrine ‐ Other metabolic disorders non alcoholic fatty liver disease; ; non alcoholic fatty liver disease Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon PRIMARY OUTCOME: Feasibility of a hypocaloric MedDiet assessed by changes and adherence to the diet at baseline and 12 weeks (3‐day food diaries), and the PREDIMED Checklist; participants recruited (% of participant eligible) and retained (completion of study based on attrition rates); interaction with web‐based intervention (website analytics) and safety (adverse events such as gastrointestinal discomfort). The systems usability scale (SUS) will also be administered to assess the MedDiet web‐based intervention platform. [baseline and 12 weeks (end intervention)] SECONDARY OUTCOME: Barriers and enablers to MedDiet adherence in a mixed methods survey will be assessed. These questions will be designed specifically for this study. [12 weeks (end intervention)] Biomarkers (Fasting glucose) using standard venepuncture and analysis [baseline and 12 weeks (end intervention)] Height using a stadiometer [Baseline and 12 weeks (end intervention)] Biomarkers (insulin ) using standard venepuncture and analysis [baseline and 12 weeks] Biomarkers (lipids) using standard venepuncture and analysis [baseline and 12 weeks] Biomarkers (liver function) using standard venepuncture and analysis [baseline and 12 weeks] Blood pressure using a digital machine[Baseline and 12 weeks (end intervention)] Body composition (lean tissue mass) will be assessed using Seca© bio electrical impedance analysis scales. [Baseline and 12 weeks (end intervention)] The Active Australia questionnaire will monitor changes in physical activity.[Baseline and 12 weeks (end intervention)] Waist circumference using a measuring tape[Baseline and 12 weeks (end intervention) ; ] Weight (kg) with a digital scale[Baseline and 12 weeks (end intervention)] INCLUSION CRITERIA: >/=18 years; BMI 25‐39.9 kg/m2; diagnosis of NAFLD determined by routine ultrasound or biopsy, eligibility for Medicare as per hospital policy.
Epistemonikos ID: ae7adb6836e1bc28ebab74058cb79bbd335eae2d
First added on: Aug 25, 2024