None listed
Conditions
Brief summary
This study will describe the usual dietary nutrient profile of a patient group with NAFLD and associations with a range of indicators of liver disease severity and cardiovascular risk. After a 3-month dietary intervention with a Mediterranean-style test diet vs. a low-fat control diet, the influence on measures of cardiovascular risk and liver fat, will be assessed. Patients will maintain their weight during this 3-month period to allow for assessment of the influence of diet, independently of the known effects of weight loss. By re-examining the same markers of liver disease severity and cardiovascular risk, the effects of the intervention and control diets will provide insight into whether there is a superior nutrient profile to improve cardiovascular risks and/or liver fat in this patient group. This will also determine if there is a role dietary therapy in NAFLD for patients who are unable lose or maintain weight loss.
Interventions
Mediterranean diet, the composition of which is high fat, high monounsaturated fat, controlled saturated fat, moderate carbohydrate. The diet will be administered to the patient group for a period of 12 weeks. The diet will be isocaloric, to avoid inducing weight loss in the intervention population, which has known beneficial effects on the primary outcome measure of hepatic steatosis.
The composition of the Mediterranean diet will be based on analysis of the 1960's Cretan Mediterranean diet:
40
Mediterranean diet, the composition of which is high fat, high monounsaturated fat, controlled saturated fat, moderate carbohydrate. The diet will be administered to the patient group for a period of 12 weeks. The diet will be isocaloric, to avoid inducing weight loss in the intervention population, which has known beneficial effects on the primary outcome measure of hepatic steatosis. The composition of the Mediterranean diet will be based on analysis of the 1960's Cretan Mediterranean diet: 40% of energy as carbohydrate; 35-40% of energy as fat with <10-15% of energy as saturated fat, <0.5% trans fatty acids; 20% of energy as protein. The total energy content of the diet will be individualised based on standard energy estimation equations. A pre-prepared diet, based on that level of energy (to the nearest 500kJ) will then be used to educate the subject. Subjects will be given lists of appropriate foods within each food group, they will be told how many serves of each group they need to consume per day and per week, and they will be given detailed information about what constitutes a 'serve' of each food. This will be combined with an individualised 'sample meal plan' which will be based on the usual patterns of intake of the subject. This is consistent with methods used by Dietitians in the administration of medical nutrition therapy and is designed to increase compliance, rather than imposing a pre-determined pattern of eating (eg. 3 meals per day), which may be highly inconsistent with the subjects normal eating patterns.
Sponsors
Catherine Properzi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
NAFLD diagnosis with hepatic steatosis (>5.5% as determined by MRS). Weight stability; variation of <5% within the preceding 3-month period.
Exclusion criteria
Secondary causes of NAFLD. Other causes of liver disease deficiency. Type 2 diabetes mellitus with A1C >8.5% or requiring insulin. Mean alcohol consumption > 20 g/day or 140 g per week in females, >30 g/day or 210 g/week in males. Decompensated liver cirrhosis. Renal failure. Malignancy aside from skin cancer. Current tobacco use. Conditions preventing required assessment or informed consent. Use of weight loss medications. Lipid lowering medications. Fish oil supplement use within the past 3 months. Pregnancy or lactation. Patients unwilling/unable to maintain stable body weight and/or comply with specifically prescribed dietary intake.
Outcome results
None listed