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

Phase 1

Completed

• Conditions: Familial Adenomatous Polyposis
• Interventions: Drug: Black raspberry (BRB) Slurry; Drug: Black Raspberry (BRB) Suppositories; Drug: Black Raspberry (BRB) Placebo Slurry

• Registration Number: NCT00770991
• Lead Sponsor: The Cleveland Clinic

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

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2008-09
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Study Completion: 2008-12
• Status Verified: 2016-02
• Results First Submitted: 2016-02-11
• Results First Submitted QC: 2016-02-11
• Last Update Submitted: 2016-02-11
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories	Black Raspberry (BRB) Placebo Slurry	20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
Black Raspberry (BRB) Slurry plus BRB suppositories	Black raspberry (BRB) Slurry	20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
Black Raspberry (BRB) Placebo Slurry plus BRB suppositories	Black Raspberry (BRB) Suppositories	20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
Black Raspberry (BRB) Slurry plus BRB suppositories	Black Raspberry (BRB) Suppositories	20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS

Primary Outcome Measures

Name	Time	Method
Change From Baseline to End of Study in Number of Rectal Polyps	Baseline and 36 weeks
Change in Burden of Rectal Polyps	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.

Secondary Outcome Measures

Name	Time	Method
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States