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Trial registered on ANZCTR


Registration number
ACTRN12612001305819
Ethics application status
Approved
Date submitted
13/12/2012
Date registered
17/12/2012
Date last updated
17/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Low Calorie Diet, Pre-biotics and Antibiotics for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Scientific title
Very low calorie diet (VLCD) followed by antibiotic, and prebiotic supplementation is superior to VLCD alone in achieving sustained weight loss and resolution of Non-Alcoholic Fatty Liver Disease.
Secondary ID [1] 281683 0
Nil
Universal Trial Number (UTN)
U1111-1137-6649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Alcoholic Fatty Liver Disease 287954 0
Obesity 287955 0
metabolic syndrome 287956 0
Condition category
Condition code
Metabolic and Endocrine 288337 288337 0 0
Metabolic disorders
Diet and Nutrition 288338 288338 0 0
Obesity
Oral and Gastrointestinal 288339 288339 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 286202 0
Treatment: Drugs
Comparator / control treatment
ARM 1 is the placebo controlled arm
Placebo antibiotic: lactose in gelatine capsule, identicle to the metronidazole capsule 500mg tds. Duration of antibiotic placebo 1 week.
Placebo pre-biotic: maltodextran powder 3x daily. Identicle container to the pre-biotic. No significant difference in taste and appearance to the inulin. Duration of placebo pre-biotic 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 288505 0
Primary outcome is maintenance of weight loss (Target 7% total body weight reduction)
Timepoint [1] 288505 0
4- weekly assessments up to end of treatment at 16 weeks
Secondary outcome [1] 300341 0
Improved insulin sensitivity (diabetic control, HOMA-IR), through blood tests
Timepoint [1] 300341 0
4- weekly assessments up to end of treatment at 16 weeks
Secondary outcome [2] 300342 0
Reduced Alanine transaminase (ALT) with blood testing
Timepoint [2] 300342 0
4- weekly assessments up to end of treatment at 16 weeks
Secondary outcome [3] 300343 0
Reduced hepatic steatosis with a fibroscan CAP (similar to an ultrasound of the liver)
Timepoint [3] 300343 0
Performed at baseline and at end of treatment at 16 weeks

Eligibility
Key inclusion criteria
Non alcoholic fatty liver disease
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Alcohol >20g/d
Medications which cause steatohepatitis
Severe medical conditions
Allergy to metronidazole
Inflammatory bowel disease
Pregnany
Decompensated liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4748 0
New Zealand
State/province [1] 4748 0

Funding & Sponsors
Funding source category [1] 286460 0
Hospital
Name [1] 286460 0
Auckland Medical Research fund
Country [1] 286460 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board, Medical research unit
Address
Level 14, Support Bldg,
Auckland City Hospital.
Private Bag 92024,
Auckland
1148
Country
New Zealand
Secondary sponsor category [1] 285248 0
None
Name [1] 285248 0
Address [1] 285248 0
Country [1] 285248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288537 0
Northern X Regional Ethics Commitee
Ethics committee address [1] 288537 0
Private Bag 92522
Wellesley Street
Auckland
1141
Ethics committee country [1] 288537 0
New Zealand
Date submitted for ethics approval [1] 288537 0
21/05/2012
Approval date [1] 288537 0
03/10/2012
Ethics approval number [1] 288537 0
NTX/12/05/040

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36590 0
Dr David Orr
Address 36590 0
NZLTU, Level 15 Support Building
Auckland Hospital
Grafton, PO box 92024
1148
Country 36590 0
New Zealand
Phone 36590 0
006493074949
Fax 36590 0
Email 36590 0
[email protected]
Contact person for public queries
Name 36591 0
David Orr
Address 36591 0
NZLTU, Level 15 Support Building
Auckland Hospital
Grafton, PO box 92024
1148
Country 36591 0
New Zealand
Phone 36591 0
006493074949
Fax 36591 0
Email 36591 0
[email protected]
Contact person for scientific queries
Name 36592 0
David Orr
Address 36592 0
NZLTU, Level 15 Support Building
Auckland Hospital
Grafton, PO box 92024
1148
Country 36592 0
New Zealand
Phone 36592 0
006493074949
Fax 36592 0
Email 36592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.