Trial Outcomes & Findings for Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP) (NCT NCT00770991)
NCT ID: NCT00770991
Last Updated: 2016-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Baseline and 36 weeks
Results posted on
2016-02-15
Participant Flow
Study was open for enrollment at Cleveland Clinic from December 9, 2005 to March 26, 2008. Subjects with FAP who had an assessable rectal segment were screened for potential eligibility. Once it was determined the subjects were potentially eligible they were contacted by phone or letter.
After potentially eligible subjects signed the informed consent, a physical examination with medical history and colonoscopy or sigmoidoscopy was performed as indicated. Blood and urine samples were collected. Subjects with adequate rectal polyp burden and laboratory results within study guidelines were eligible to be randomized.
Participant milestones
| Measure |
Placebo Powder Plus 2 Berry Suppositories
20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
|
Black Raspberry Slurry Plus 2 Berry Suppositories
20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo Powder Plus 2 Berry Suppositories
20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
|
Black Raspberry Slurry Plus 2 Berry Suppositories
20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Baseline characteristics by cohort
| Measure |
Two Berry Suppositories Bedtime Plus Oral Berry Powder
n=12 Participants
20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
|
Two Berry Suppositories Bedtime Plus Placebo Powder
n=12 Participants
20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 36 weeksOutcome measures
| Measure |
Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo
n=7 Participants
Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
|
Lypholized BRB Suppositiry Plus BRB Slurry
n=7 Participants
2 lyphilized black raspberry suppositories plus black raspberry slurry.
|
All Participants
n=14 Participants
|
|---|---|---|---|
|
Change From Baseline to End of Study in Number of Rectal Polyps
|
-5.4 polyps
Standard Deviation 5.3
|
-1.6 polyps
Standard Deviation 9.2
|
-3.5 polyps
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Baseline and 36 weeksThe 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.
Outcome measures
| Measure |
Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo
n=7 Participants
Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
|
Lypholized BRB Suppositiry Plus BRB Slurry
n=7 Participants
2 lyphilized black raspberry suppositories plus black raspberry slurry.
|
All Participants
n=14 Participants
|
|---|---|---|---|
|
Change in Burden of Rectal Polyps
|
-13 polyp number x mm
Standard Deviation 11.7
|
-5.7 polyp number x mm
Standard Deviation 26.6
|
-9.4 polyp number x mm
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: baseline and 36 weeksA 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.
Outcome measures
| Measure |
Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo
n=14 Participants
Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
|
Lypholized BRB Suppositiry Plus BRB Slurry
n=14 Participants
2 lyphilized black raspberry suppositories plus black raspberry slurry.
|
All Participants
|
|---|---|---|---|
|
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
Tunel assay at baseline
|
0.58 percentage of brown staining of cells
Standard Deviation 0.10
|
4.49 percentage of brown staining of cells
Standard Deviation 0.95
|
—
|
|
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
KI 67 assay at baseline
|
11.3 percentage of brown staining of cells
Standard Deviation 1.14
|
55.2 percentage of brown staining of cells
Standard Deviation 2.81
|
—
|
|
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
KI 67 at 36 weeks
|
8.00 percentage of brown staining of cells
Standard Deviation 1.07
|
49.12 percentage of brown staining of cells
Standard Deviation 2.28
|
—
|
|
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
Difference in means of KI 67
|
-3.30 percentage of brown staining of cells
Standard Deviation 1.23
|
-6.08 percentage of brown staining of cells
Standard Deviation 1.83
|
—
|
|
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
Tunel assay at 36 weeks
|
1.08 percentage of brown staining of cells
Standard Deviation 0.33
|
7.64 percentage of brown staining of cells
Standard Deviation 1.17
|
—
|
|
Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
Difference in mean of Tunel
|
0.50 percentage of brown staining of cells
Standard Deviation 0.33
|
3.15 percentage of brown staining of cells
Standard Deviation 1.20
|
—
|
Adverse Events
Black Raspberry Placebo Slurry Plus 2 Berry Suppositories
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Black Raspberry Slurry Plus 2 Berry Suppositories
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Black Raspberry Placebo Slurry Plus 2 Berry Suppositories
n=12 participants at risk
20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
|
Black Raspberry Slurry Plus 2 Berry Suppositories
n=12 participants at risk
20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
|
|---|---|---|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
Other adverse events
| Measure |
Black Raspberry Placebo Slurry Plus 2 Berry Suppositories
n=12 participants at risk
20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
|
Black Raspberry Slurry Plus 2 Berry Suppositories
n=12 participants at risk
20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal bloating
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
16.7%
2/12 • Number of events 2 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
16.7%
2/12 • Number of events 2 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • Number of events 5 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
General disorders
Increased appetite
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Flatulance
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 4 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
58.3%
7/12 • Number of events 7 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
16.7%
2/12 • Number of events 2 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 2 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
16.7%
2/12 • Number of events 2 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Hepatobiliary disorders
Elevated ALT and AST
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Rectal pain
|
33.3%
4/12 • Number of events 4 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
41.7%
5/12 • Number of events 5 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Rectal bleeding
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
16.7%
2/12 • Number of events 2 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
|
Nervous system disorders
Cramping in extremities
|
0.00%
0/12 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
8.3%
1/12 • Number of events 1 • Reported Adverse Events (AEs) include events starting day first dose study agent taken to end of study visit at 36 weeks. Subjects contacted at monthly intervals for AE evaluation.
Subjects asked to complete diary to record date and time study agent consumed, time suppository inserted, changes in their health, visits to any physician, changes in medications and overnight hospitalizations. If a subject experienced more than 1 of a given AE, subject is counted only once for that AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place