Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)

study id #: NCT00770991

condition: Familial Adenomatous Polyposis

status: completed

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.

intervention:
Drug: Black raspberry (BRB) Slurry
Drug: Black Raspberry (BRB) Suppositories
Drug: Black Raspberry (BRB) Placebo Slurry

results: https://clinicaltrials.gov/ct2/show/results/NCT00770991

start date: December 2005

estimated completion: December 2008

last updated: February 15, 2016

phase of development: Phase 1

size / enrollment: 34

study design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

primary outcomes:

• Change From Baseline to End of Study in Number of Rectal Polyps [ Time Frame: Baseline and 36 weeks ] [ Designated as safety issue: No ]
  
• Change in Burden of Rectal Polyps [ Time Frame: Baseline and 36 weeks ] [ Designated as safety issue: No ]
  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.

secondary outcomes:

• Apoptosis and Cell Proliferation Measured by Percent Difference in Staining. [ Time Frame: baseline and 36 weeks ] [ Designated as safety issue: No ]
  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.

inclusion criteria:

exclusion criteria:
- Known allergies or hypersensitivity to berries
- Diabetes mellitus
- Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.

sponsor: The Cleveland Clinic

investigators: Carol A Burke, MD

trial center locations: United States