Clinical Trial Details

Trial ID: L0927
Source ID: ACTRN12612001135808
Associated Drug: Trans-resveratrol
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 metab
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: non-alcoholic fatty liver disease; <br>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 live
Interventions: 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
Outcome Measures: Degree of peripheral insulin resistance measured by the euglycemic hyperinsulinemic clamp method[Baseline and at the end of study (8 weeks)]Hepatic steatosis mesured by MRS[Baseline and at the end of study (8 weeks)];Abdominal fat distribution (visceral or subcutaneous) measured by MRI[Baseline and at the end of study (8 weeks)];Plasma inflammatory panel: IL-1B, IL-6, IL-8, IL-10, CRP, TNFa[Baseline and at the end of study (8 weeks)];Plasma oxidative stress and antioxidant activity: Isoprostanes, FRAP, GPX, SOD, TAC[Baseline and at the end of study (8 weeks)];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[Baseline and at the end of study (8 weeks)];Blood pressure and anthropometrics: weight, BMI, waist circumference, lean body weight[Baseline and at the end of study (8 weeks)];Compliance and pharmacokinetics of resveratrol: weekly resveratrol concentration and 6 hours pharmacokinetics study post dosing at the end of the 8 weeks intervention[-Weekly from week 1 to 8, for compliance measure (weekly concentration of resveratrol) <br> <br>- 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.];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[The 3 timepoints at which the PBMC are collected are: -Baseline before the start of the intervention <br>-At week 1 <br>-At week 8 (end of study) <br>Blood samples are always taken in fasted state.]
Sponsor/Collaborators: Metro-South Queensland health
Gender: Male
Age: 18 Years65 Years
Phases: Phase 2/Phase 3
Enrollment: 20
Study Type: Interventional
Study Designs: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
Start Date: 24/10/2012
Completion Date: --
Results First Posted: --
Last Update Posted: 13 January 2020
Locations: Australia
URL: https://anzctr.org.au/ACTRN12612001135808.aspx