None listed
Conditions
Brief summary
Non-alcoholic liver disease (NAFLD) affects 20-30% of the population and significantly increases the risk of liver related all-cause mortality, transplant, cardiovascular disease and liver cancer. There are no proven safe or effective pharmacotherapies and current management targets weight loss. In the absence of optimal diet and exercise prescription effective management strategies for NAFLD require urgent attention. There are currently no established recommendations for diet or exercise prescription to achieve weight loss. Establishing an effective management strategy for NAFLD, in light of the high (~5.5 million Australians in 2021) and increasing prevalence of the condition, is a public health priority. Weight loss is the current recommendation for NAFLD and known to improve liver and cardiovascular outcomes. The Mediterranean Diet (MedDiet) is a promising intervention, improving body composition and metabolic risk factors in the absence of weight loss. These benefits are attributable to the MedDiet’s anti-inflammatory and antioxidant composition. Thus, developing a better understanding of the combined benefits of weight loss and MedDiet on body composition will facilitate the development of evidence-based interventions that can be translated into practice to improve outcomes for people with NAFLD. Rationale/Justification: The proposed research is significant as this innovative research will be the first worldwide to assess the feasibility of a web based hypocaloric MedDiet in NAFLD, in a non-Mediterranean cohort. A concept that would translate to an intervention that is novel yet simple, as well as cost effective, and can be integrated into practice.
Interventions
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 r
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Non-English speaking; consume on average >140 g/week of alcohol; medications: immunosuppressants, amiodarone and/or perhexiline; a diagnosis of insulin dependent diabetes mellitus or taking gliclazides; pregnancy.
Outcome results
None listed