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

NCT00770991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-02-15

Study results available
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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.

Conditions

Interventions

DRUG

Black raspberry (BRB) Slurry

20 grams BRB Slurry

DRUG

Black Raspberry (BRB) Suppositories

Two, 730 mg BRB suppositories QHS

DRUG

Black Raspberry (BRB) Placebo Slurry

20 grams BRB placebo slurry

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Carol A Burke, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00770991 on ClinicalTrials.gov