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 ]

A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.


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