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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-12-31

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.

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Detailed Description

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Conditions

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Familial Adenomatous Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Black Raspberry (BRB) Slurry plus BRB suppositories

20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS

Group Type EXPERIMENTAL

Black raspberry (BRB) Slurry

Intervention Type DRUG

20 grams BRB Slurry

Black Raspberry (BRB) Suppositories

Intervention Type DRUG

Two, 730 mg BRB suppositories QHS

Black Raspberry (BRB) Placebo Slurry plus BRB suppositories

20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS

Group Type EXPERIMENTAL

Black Raspberry (BRB) Suppositories

Intervention Type DRUG

Two, 730 mg BRB suppositories QHS

Black Raspberry (BRB) Placebo Slurry

Intervention Type DRUG

20 grams BRB placebo slurry

Interventions

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Black raspberry (BRB) Slurry

20 grams BRB Slurry

Intervention Type DRUG

Black Raspberry (BRB) Suppositories

Two, 730 mg BRB suppositories QHS

Intervention Type DRUG

Black Raspberry (BRB) Placebo Slurry

20 grams BRB placebo slurry

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No