Resveratrol in the prevention of colorectal polyps

Interventions: This study will recruit 128 participants with a family history of colorectal cancer. The trial will be a randomized double blind, parallel design intervention after a 3-week washout period on a controlled diet. The controlled diet to be used was developed by Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition and this will be matched against known ingredients high in phenolic compounds. Blood and rectal biopsy samples will be collected for mucosal biomarkers measures. Randomized interventions will follow for 6 weeks with 100mL of dealcoholised red wine containing 50 mg resveratrol or a placebo consumed daily with the evening meal. Blood and biopsies will then be done again. The use of de-alcoholised wine will remove any risk of alcohol toxicity or cancer induction risk.
Primary outcome(s): inflammation biomarkers (eg IL-6, CRP) , through rectal biopsies[at six weeks on conclusion of intervention];expression of genes involved in normal structure and function of colorectal epithelium altered early in colorectal carcinogenesis, through rectal biopsies (Ki67 and TGF markers, apotosis markers Bax, Bc12 and bak, APC, beta-catenin and mismatch repair proteins)[at six weeks on conclusion of intervention];colorectal epithelial crypt cell cycle events, through rectal biopsies[at six weeks on conclusion of intervention]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy