NCT00770991

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

October 9, 2008

Results QC Date

February 11, 2016

Last Update Submit

February 11, 2016

Conditions

Familial Adenomatous Polyposis

Keywords

Polyp, Familial Adenomatous Polyposis, Prevention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.

    baseline and 36 weeks

Study Arms (2)

Black Raspberry (BRB) Slurry plus BRB suppositories

EXPERIMENTAL

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

Drug: Black raspberry (BRB) SlurryDrug: Black Raspberry (BRB) Suppositories

Black Raspberry (BRB) Placebo Slurry plus BRB suppositories

EXPERIMENTAL

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

Drug: Black Raspberry (BRB) SuppositoriesDrug: Black Raspberry (BRB) Placebo Slurry

Interventions

Black raspberry (BRB) SlurryDRUG

20 grams BRB Slurry

Black Raspberry (BRB) Slurry plus BRB suppositories
Black Raspberry (BRB) SuppositoriesDRUG

Two, 730 mg BRB suppositories QHS

Black Raspberry (BRB) Placebo Slurry plus BRB suppositoriesBlack Raspberry (BRB) Slurry plus BRB suppositories
Black Raspberry (BRB) Placebo SlurryDRUG

20 grams BRB placebo slurry

Black Raspberry (BRB) Placebo Slurry plus BRB suppositories

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Adenomatous Polyposis ColiPolyps

Interventions

Suppositories

Condition Hierarchy (Ancestors)

Adenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Carol Burke
Organization
Cleveland Clinic
burkec1@ccf.org
216 444-6864

Study Officials

  • Carol A Burke, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

December 1, 2005

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

February 15, 2016

Results First Posted

February 15, 2016

Record last verified: 2016-02

Locations

US(1)