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

Study Overview
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Brief Summary
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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.

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

Conditions
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Familial Adenomatous Polyposis

Intervention / Treatment
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* Drug: Black raspberry (BRB) Slurry
* Drug: Black Raspberry (BRB) Suppositories
* Drug: Black Raspberry (BRB) Placebo Slurry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black Raspberry (BRB) Slurry plus BRB suppositories<br>20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS | Drug: Black raspberry (BRB) Slurry<br>* 20 grams BRB Slurry<br>Drug: Black Raspberry (BRB) Suppositories<br>* Two, 730 mg BRB suppositories QHS<br>|
| Experimental: Black Raspberry (BRB) Placebo Slurry plus BRB suppositories<br>20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS | Drug: Black Raspberry (BRB) Suppositories<br>* Two, 730 mg BRB suppositories QHS<br>Drug: Black Raspberry (BRB) Placebo Slurry<br>* 20 grams BRB placebo slurry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Study in Number of Rectal Polyps |  | Baseline and 36 weeks | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyp, Familial Adenomatous Polyposis, Prevention