Resveratrol in the prevention of colorectal polyps

Resveratrol in the chemoprevention of colorectal neoplasia in people with high risk of colorectal cancer including carriers of Hereditary Non-polyposis Colorectal Cancer and their families, people who have had colorectal cancer and people who have had colorectal polyps

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000560998

Enrollment

130

Registered

2011-06-01

Start date

2009-10-19

Completion date

2014-11-10

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

This study aims to determine whether Resveratrol (contained in red wine) may prevent colorectal cancer in people with a family history of the disease. Who is it for? You can join this study if you are aged 18 years or more and are a carrier of hereditary non-polyposis colorectal cancer (HNPCC). Trial details Participants in this trial will eat a controlled diet developed by the CSIRO for a period of 3 weeks. They will then be randomly (by chance) divided into two groups. One group will consume 100ml of dealcoholised red wine containing 50 mg resveratrol daily with their evening meal for a period of 6 weeks. Participants in the other group will consume a placebo (sham) drink containing no resveratrol. Participants will not know which group they are in. Blood and rectal biopsy samples will be taken from participants at the beginning and end of this study to assess any changes in markers associated with colorectal cancer.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

HNPCC carriers

Exclusion criteria

pregnancy, co-morbidities

Outcome results