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

Familial Adenomatous Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770991
• Other study ID #: 2003-34501-13965
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2008
• Last updated: February 11, 2016
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Familial Adenomatous Polyposis

Intervention

Drug:
• Black raspberry (BRB) Slurry
20 grams BRB Slurry
• Black Raspberry (BRB) Suppositories
Two, 730 mg BRB suppositories QHS
• Black Raspberry (BRB) Placebo Slurry
20 grams BRB placebo slurry

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Study in Number of Rectal Polyps		Baseline and 36 weeks	No
Primary	Change in Burden of Rectal Polyps	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.	Baseline and 36 weeks	No
Secondary	Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.	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.	baseline and 36 weeks	No