Conditions: Familial Adenomatous Polyposis
Keywords: Polyp, Familial Adenomatous Polyposis, Prevention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

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 description:

Arms:
arm 1: 20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS arm 2: 20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS

Interventions: intervention 1: Black raspberry (BRB) Slurry intervention 2: Black Raspberry (BRB) Suppositories intervention 3: Black Raspberry (BRB) Placebo Slurry
Intervention descriptions: intervention 1: 20 grams BRB Slurry intervention 2: Two, 730 mg BRB suppositories QHS intervention 3: 20 grams BRB placebo slurry

Protocol document: