None listed
Conditions
Brief summary
The aim of the study is to initiate weight loss with a very low calorie diet for 4-weeks, then alter gastrointestinal flora using prophylactic antibiotic therapy followed by prebiotic supplementation (with the usual diet) and assess efficacy in maintaining weight loss and amelioration of non alcoholic fatty liver disease. This will be a randomised controlled trial.
Interventions
All patients recieve 4 weeks Optifast low calorie diet. Optifast will be a meal replacement three times a day. 2 cups of vegetables also allowed during the day (800cal/day). Patients then randomised to one of three arms. Arm 1 Placebo (1 week placebo antibiotic orally 3 times a day) and placebo prebiotic orally 3 times a day for 12 weeks), Arm 2 Placebo antibiotic (1 week placebo antibiotic orally 3 times a day) + Prebiotic (inulin) 8g orally pre-meals for 12 weeks. Arm 3 Antibiotic (metronidazo
All patients recieve 4 weeks Optifast low calorie diet. Optifast will be a meal replacement three times a day. 2 cups of vegetables also allowed during the day (800cal/day). Patients then randomised to one of three arms. Arm 1 Placebo (1 week placebo antibiotic orally 3 times a day) and placebo prebiotic orally 3 times a day for 12 weeks), Arm 2 Placebo antibiotic (1 week placebo antibiotic orally 3 times a day) + Prebiotic (inulin) 8g orally pre-meals for 12 weeks. Arm 3 Antibiotic (metronidazole 3 times orally per day for 1 week) + Prebiotic (inulin), 8g pre-meals orally for 12 weeks
Sponsors
Auckland District Health Board, Medical research unit
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Non alcoholic fatty liver disease
Exclusion criteria
Alcohol >20g/d Medications which cause steatohepatitis Severe medical conditions Allergy to metronidazole Inflammatory bowel disease Pregnany Decompensated liver disease
Outcome results
None listed