The effect of mediterranean diet on the microbes community and immune response in fatty liver disease.

Not Applicable

Not yet recruiting

Conditions: on alcoholic fatty liver disease
Hepatocellular carcinoma
Non alcoholic fatty liver disease
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer - Liver
Diet and Nutrition - Obesity

Registration Number: ACTRN12620000611921

Lead Sponsor: SW Sydney

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The gut microbiome assessed by 16S RNA sequencing of stool samples.<br>[The primary outcome is assessed at Baseline, 6 weeks and 12 weeks. The primary timepoint will be 12 weeks. ];The immune response assessed by flow cytometry to profile white blood cells.[The primary outcome is assessed at Baseline, 6 weeks and 12 weeks. The primary timepoint will be 12 weeks.]

Secondary Outcome Measures