ow Calorie Diet, Pre-biotics and Antibiotics for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Not Applicable

• Conditions: on Alcoholic Fatty Liver Disease; Obesity; metabolic syndrome; Non Alcoholic Fatty Liver Disease; Metabolic and Endocrine - Metabolic disorders; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612001305819
• Lead Sponsor: Auckland District Health Board, Medical research unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is maintenance of weight loss (Target 7% total body weight reduction)[4- weekly assessments up to end of treatment at 16 weeks]

Secondary Outcome Measures

Name	Time	Method
Improved insulin sensitivity (diabetic control, HOMA-IR), through blood tests[4- weekly assessments up to end of treatment at 16 weeks];Reduced Alanine transaminase (ALT) with blood testing[4- weekly assessments up to end of treatment at 16 weeks];Reduced hepatic steatosis with a fibroscan CAP (similar to an ultrasound of the liver)[Performed at baseline and at end of treatment at 16 weeks]