The role of resveratrol in the management of metabolic dysregulations in non-alcoholic fatty liver disease: a randomised placebo controlled clinical trial

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001135808

Enrollment

Registered

2012-10-24

Start date

2011-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Diagnosed with NAFLD on ultrasound

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

Outcome results