None listed
Conditions
Brief summary
The purpose of this study is to see how the microbial community and immune system in people with liver disease responds to a Mediterranean diet. Who is it for? You may be eligible for this study if you or a member of your immediate (household) family have fatty liver disease, including liver cancer. Study details All participants in this study will be provided with 5 meals a day of the Mediterranean diet. This includes 3 main meals and two snacks. The Mediterranean diet is rich in polyunsaturated fats, fibres, polyphenols, vitamins and carotenoids. As part of this study, participants will provide stool, urine, blood and mouth swab samples and complete dietary and quality of life questionnaires. The results of those with liver disease and liver cancer will be compared to the results of their family members without these conditions. It is hoped this study will show the change in diet drives a more diverse gut microbial community and this has a positive effect on the immune and anti-cancer profile of participants.
Interventions
Participants will receive Mediterranean diet consisting of 5 meals/day (3 main meals and two snacks) for 12 weeks. The Mediterranean diet is a plant-based diet rich in polyunsaturated fats, fibre, polyphenols, vitamins and carotenoids, with low red meats consumption and increase of fish.
An example of breakfast is Greek yogurt with sliced fruits and oats, An example of lunch is Whole-grain sandwich with grilled vegetables, such as eggplant, zucchini, bell pepper, and onion, with fruit for desse
Participants will receive Mediterranean diet consisting of 5 meals/day (3 main meals and two snacks) for 12 weeks. The Mediterranean diet is a plant-based diet rich in polyunsaturated fats, fibre, polyphenols, vitamins and carotenoids, with low red meats consumption and increase of fish. An example of breakfast is Greek yogurt with sliced fruits and oats, An example of lunch is Whole-grain sandwich with grilled vegetables, such as eggplant, zucchini, bell pepper, and onion, with fruit for dessert. An example of dinner is whole-grain pasta with tomato sauce, olive oil, and grilled vegetables. Examples of snacks include a small serving of nuts, whole fruits, dried fruit, or a small serving of yogurt. No drinks are provided or prescribed as part of this intervention - patients will be encouraged to drink water. Tea and Coffee is acceptable as well. Participants will be provided with a food diary - they will make note of any meals provided they did not consume, or foods consumed that were outside of their meal plan.
Sponsors
UNSW Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with well compensated, Child Pugh A, NAFLD related liver cirrhosis, including those who have undergone resection for HCC. 2. Patients under the care of the investigators of this study (or their associates) who routinely visit study sites for treatment or care 3. Patients willing to provide informed consent 4. Participants must be motivated to eat pre-prepared foods for 12 weeks 5. Participant is aged between 18-75 years old 6. Participant is willing and able to provide a stool, urine, blood and oral sample for this study 7. Participant has not taken any antibiotic medication within the past 3 months For control group: Participant is part of the same household than patient recruited and presenting good health
Exclusion criteria
1. Participant unwilling or unable to provide informed consent 2. Patient with clinical or biochemical evidence of portal hypertension 3. Patients with other causes of liver disease, not NAFLD related including alcoholic liver disease and viral hepatitis 4. Participant who has taken any antibiotic medication within the past 3 months 5. Participant with diagnosed food allergy or intolerance 6. Participant is pregnant or breastfeeding 7. Participant has received nutritional counselling in the previous 3 months 8. Participants have medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet
Outcome results
None listed