Clinical Trial: Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
Brief Summary: This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.
Detailed Summary:
Sponsor: The Cleveland Clinic
Current Primary Outcome:
- Change From Baseline to End of Study in Number of Rectal Polyps [ Time Frame: Baseline and 36 weeks ]
- Change in Burden of Rectal Polyps [ Time Frame: Baseline and 36 weeks ]The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.
Original Primary Outcome: To determine whether daily exposure of Black Raspberries reduces the number of rectal polyps in subjects with FAP. [ Time Frame: 36 weeks ]
Current Secondary Outcome: Apoptosis and Cell Proliferation Measured by Percent Difference in Staining. [ Time Frame: baseline and 36 weeks ]
Original Secondary Outcome: Biomarker indices from biopsies of normal rectal mucosa, polyps and aberrant crypt foci will be evaluated at baseline and 36 weeks to determine if black raspberries modulate their activity. [ Time Frame: 36 weeks ]
Information By: The Cleveland Clinic
Dates:
Date Received: October 9, 2008
Date Started: December 2005
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016