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

This study has been completed.
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Carol Burke, MD, The Cleveland Clinic Identifier:
First received: October 9, 2008
Last updated: February 11, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Familial Adenomatous Polyposis
Drug: Black raspberry (BRB) Slurry
Drug: Black Raspberry (BRB) Suppositories
Drug: Black Raspberry (BRB) Placebo Slurry
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change From Baseline to End of Study in Number of Rectal Polyps [ Time Frame: Baseline and 36 weeks ]
  • Change in Burden of Rectal Polyps [ Time Frame: 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:
  • Apoptosis and Cell Proliferation Measured by Percent Difference in Staining. [ Time Frame: 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.

Enrollment: 34
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Black Raspberry (BRB) Slurry plus BRB suppositories
20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
Drug: Black raspberry (BRB) Slurry
20 grams BRB Slurry
Drug: Black Raspberry (BRB) Suppositories
Two, 730 mg BRB suppositories QHS
Experimental: Black Raspberry (BRB) Placebo Slurry plus BRB suppositories
20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
Drug: Black Raspberry (BRB) Suppositories
Two, 730 mg BRB suppositories QHS
Drug: Black Raspberry (BRB) Placebo Slurry
20 grams BRB placebo slurry


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00770991

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Ohio State University Comprehensive Cancer Center
Principal Investigator: Carol A Burke, MD The Cleveland Clinic
  More Information

Responsible Party: Carol Burke, MD, Principal Investigator, The Cleveland Clinic Identifier: NCT00770991     History of Changes
Other Study ID Numbers: 2003-34501-13965
Study First Received: October 9, 2008
Results First Received: February 11, 2016
Last Updated: February 11, 2016

Keywords provided by The Cleveland Clinic:
Polyp, Familial Adenomatous Polyposis, Prevention

Additional relevant MeSH terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn processed this record on May 23, 2017