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Trial registered on ANZCTR


Registration number
ACTRN12612001135808
Ethics application status
Approved
Date submitted
20/10/2012
Date registered
24/10/2012
Date last updated
24/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of resveratrol in the management of metabolic dysregulations in non-alcoholic fatty liver disease: a randomised placebo controlled clinical trial
Scientific title
An 8 week randomised, double blind, placebo controlled clinical trial investigating the effects of 3000mg daily trans-resveratrol on peripheral insulin resistance, systemic inflammation, hepatic steatosis, abdominal adipose tissue topography, plasma metabolic markers, gene expression in peripheral blood mono-nuclear cells and anthropometry in male patients with non-alcoholic fatty liver disease, aged 18-65years.
Secondary ID [1] 281415 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-alcoholic fatty liver disease 261186 0
Condition category
Condition code
Metabolic and Endocrine 288013 288013 0 0
Metabolic disorders
Diet and Nutrition 288021 288021 0 0
Obesity
Oral and Gastrointestinal 288029 288029 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
10 male patients diagnosed with non-alcoholic fatty liver disease will receive 3000mg trans-resveratrol daily in 2x1500mg daily doses as oral capsules for 8 weeks
Intervention code [1] 285920 0
Treatment: Drugs
Comparator / control treatment
10 males patients diagsnied with non-alcoholic fatty liver disease will received 3000mg micro-cellulose placebo capsules daily in 2 x 1500mg doses as oral capsules for 8 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 288214 0
Degree of peripheral insulin resistance measured by the euglycemic hyperinsulinemic clamp method
Timepoint [1] 288214 0
Baseline and at the end of study (8 weeks)
Secondary outcome [1] 299615 0
Hepatic steatosis mesured by MRS
Timepoint [1] 299615 0
Baseline and at the end of study (8 weeks)
Secondary outcome [2] 299616 0
Abdominal fat distribution (visceral or subcutaneous) measured by MRI
Timepoint [2] 299616 0
Baseline and at the end of study (8 weeks)
Secondary outcome [3] 299617 0
Plasma inflammatory panel: IL-1B, IL-6, IL-8, IL-10, CRP, TNFa
Timepoint [3] 299617 0
Baseline and at the end of study (8 weeks)
Secondary outcome [4] 299618 0
Plasma oxidative stress and antioxidant activity: Isoprostanes, FRAP, GPX, SOD, TAC
Timepoint [4] 299618 0
Baseline and at the end of study (8 weeks)
Secondary outcome [5] 299619 0
Plasma metabolic function markers: ALT, AST, GGT, ALP, Bilirubin, Lipid profile, Glucose, Insulin, C-peptide, Iron studies, Vitamin C, Creatinine, Potassium, IGF-1, IGFBP-3
Timepoint [5] 299619 0
Baseline and at the end of study (8 weeks)
Secondary outcome [6] 299620 0
Blood pressure and anthropometrics: weight, BMI, waist circumference, lean body weight
Timepoint [6] 299620 0
Baseline and at the end of study (8 weeks)
Secondary outcome [7] 299621 0
Compliance and pharmacokinetics of resveratrol: weekly resveratrol concentration and 6 hours pharmacokinetics study post dosing at the end of the 8 weeks intervention
Timepoint [7] 299621 0
-Weekly from week 1 to 8, for compliance measure (weekly concentration of resveratrol)

- Pharmacokinetics post-dosing: on the last day of study, subjects come in to the hospital for the end of study investigations fasted. They receive the dose and sampling is at 10,20,30,45,60,90,120,180,240,300,360 minutes post dosing.
Secondary outcome [8] 299622 0
Change in target genes expression in peripheral blood mononuclear cells (PBMC) collected at 3 time points: HO-1, IL-6, IL-10, NQO1, PTB-1B
Timepoint [8] 299622 0
The 3 timepoints at which the PBMC are collected are: -Baseline before the start of the intervention
-At week 1
-At week 8 (end of study)
Blood samples are always taken in fasted state.

Eligibility
Key inclusion criteria
Diagnosed with NAFLD on ultrasound
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
-Viral hepatitis or other known cause for non-alcoholic liver disease such as use of hepato-toxic medications (eg. tamoxifen, methatrexane)
-Presence of metallic implants unsuitable for magnetic resonance, or a pace-maker
-Cirrhosis
-Ethanol consumption above 40g daily
-Type 1 or 2 diabetes
-Allergy to polyphenols
-Inability undergo all investigations

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)
Subjects are recruited through hepatology outpatient clinics and hospital and university intranet. Subject are screened by the hepatologist and consented by the PI. The hospital clinical trials pharmacy coordinator randomises the subjects by computerised sequence generation as they have given written consent to participate in the study. All investigators are blinded to the randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5882 0
4101
Recruitment postcode(s) [2] 5883 0
4102

Funding & Sponsors
Funding source category [1] 286178 0
Charities/Societies/Foundations
Name [1] 286178 0
Princess Alexandra Research Foundation
Country [1] 286178 0
Australia
Funding source category [2] 286179 0
Charities/Societies/Foundations
Name [2] 286179 0
Lions Medical Research Foundation
Country [2] 286179 0
Australia
Funding source category [3] 286180 0
Government body
Name [3] 286180 0
National Health and Medical Research Council
Country [3] 286180 0
Australia
Primary sponsor type
Government body
Name
Metro-South Queensland health
Address
Princess Alexandra Hospital
199 Ipswich Road Woolloongabba QLD 4102.
Country
Australia
Secondary sponsor category [1] 284990 0
University
Name [1] 284990 0
University of Queensland Diamantina Institute
Address [1] 284990 0
Level 4, R wing, Princess Alexandra Hospital, Ipswich road Woolloongabba, QLD 4102
Country [1] 284990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288250 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 288250 0
Level 2, Building 35, Princess Alexandra Hospital, 199 Ipswich road Woolloongabba, QLD 4102
Ethics committee country [1] 288250 0
Australia
Date submitted for ethics approval [1] 288250 0
Approval date [1] 288250 0
14/07/2010
Ethics approval number [1] 288250 0
HREC/09/QPAH/231
Ethics committee name [2] 288251 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 288251 0
Research and Innovation Division, Cumbrae-Stewart Building, the university of Queensland, St Lucia QLD 4072
Ethics committee country [2] 288251 0
Date submitted for ethics approval [2] 288251 0
Approval date [2] 288251 0
16/09/2010
Ethics approval number [2] 288251 0
2010001168
Ethics committee name [3] 288252 0
Centre for Advanced Imaging Scientific Committee
Ethics committee address [3] 288252 0
Centre for Advanced Imaging
University of Queensland, St Lucia, QLD 4072
Ethics committee country [3] 288252 0
Australia
Date submitted for ethics approval [3] 288252 0
Approval date [3] 288252 0
14/02/2011
Ethics approval number [3] 288252 0
(as per UQ HREC number) 2010001168

Summary
Brief summary
The study aims to investigate the role of a bioactive food compound called resveratrol, found in grapes, peanuts, berries and derived food products and beverages, in the treatment of obesity related fatty liver disease. Studies in animal models of fatty liver disease have shown promising results with resveratrol treatment: improvement of insulin sensitivity, prevention of fat accumulation in the liver, reduction of inflammation and increased antioxidant activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32229 0
Address 32229 0
Country 32229 0
Phone 32229 0
Fax 32229 0
Email 32229 0
Contact person for public queries
Name 15476 0
Veronique Chachay
Address 15476 0
University of Queensland Diamantina Institute, Level 4, R wing Princess Alexandra Hospital, Ipswich road, Woolloongabba QLD, 4102
Country 15476 0
Australia
Phone 15476 0
+61 7 3176 5260
Fax 15476 0
Email 15476 0
[email protected]
Contact person for scientific queries
Name 6404 0
Veronique Chachay
Address 6404 0
University of Queensland Diamantina Institute, Level 4, R wing Princess Alexandra Hospital, Ipswich road, Woolloongabba QLD, 4102
Country 6404 0
Australia
Phone 6404 0
+61 7 3176 5260
Fax 6404 0
Email 6404 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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