Status:
COMPLETED
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Ohio State University Comprehensive Cancer Center
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 colonosc...
Eligibility Criteria
Inclusion
- Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy
- Have an endoscopically assessable rectal segment
- Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00770991
Start Date
December 1 2005
End Date
December 1 2008
Last Update
February 15 2016
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195