NCT00770991

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

A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Familial Adenomatous Polyposis

Interventions

Type	Name	Description
DRUG	Black raspberry (BRB) Slurry	20 grams BRB Slurry
DRUG	Black Raspberry (BRB) Suppositories	Two, 730 mg BRB suppositories QHS
DRUG	Black Raspberry (BRB) Placebo Slurry	20 grams BRB placebo slurry

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2008-10-10
• Last updated: 2016-02-15
• Results posted: 2016-02-15

Locations

1 site across 1 country: United States