Trial Outcomes & Findings for Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma (NCT NCT01948661)
NCT ID: NCT01948661
Last Updated: 2024-11-21
Results Overview
Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
baseline and 4 weeks
Results posted on
2024-11-21
Participant Flow
53 participants were contacted: * 8 refused to participate, * 45 signed the Informed Consent: 10 were not eligible and 35 were randomized
Participant milestones
| Measure |
Experimental: Anthocyanins+Phospholipidic Curcumin
Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days
|
Placebo Comparator
placeboA + placeboB per day for four weeks
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Experimental: Anthocyanins+Phospholipidic Curcumin
Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days
|
Placebo Comparator
placeboA + placeboB per day for four weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=15 Participants
Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days
|
Control Arm
n=14 Participants
Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Level of Education
Primary-middle
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Level of Education
High university
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Smoker
No
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Smoker
Former
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Smoker
Yes
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Alcholol Habits
No
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Alcholol Habits
Current/Former
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Baseline BMI
<25 kg/m^2
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Baseline BMI
≥25 kg/m^2
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Family history of colorectal cancer
No
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Family history of colorectal cancer
Yes
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Baseline histological type
Tubular
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Baseline histological type
Villous
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Baseline Dysplasia grade
Low-grade
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Baseline Dysplasia grade
High-grade
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
# of comorbidity
|
1 number of comorbidities
n=5 Participants
|
2 number of comorbidities
n=7 Participants
|
2 number of comorbidities
n=5 Participants
|
|
# of concomitant medications
|
2 number of concomitant medications
n=5 Participants
|
4 number of concomitant medications
n=7 Participants
|
3 number of concomitant medications
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksPopulation: Beta-catenin expression according to the treatment arms and the time points in normal tissue and dysplasia
Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue
Outcome measures
| Measure |
Experimental Arm
n=15 Participants
Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days
|
Control Arm
n=14 Participants
Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die
|
|---|---|---|
|
Change in Beta Catenin Expression
Pre-treatment: Dysplasia
|
100 percentage of positive cells
Standard Deviation 0
|
100 percentage of positive cells
Standard Deviation 0
|
|
Change in Beta Catenin Expression
Pre-treatment: Normal tissue
|
100 percentage of positive cells
Standard Deviation 0
|
100 percentage of positive cells
Standard Deviation 0
|
|
Change in Beta Catenin Expression
Post-treatment: Normal tissue
|
100 percentage of positive cells
Standard Deviation 0
|
100 percentage of positive cells
Standard Deviation 0
|
|
Change in Beta Catenin Expression
Post-treatment: Dysplasia
|
100 percentage of positive cells
Standard Deviation 0
|
100 percentage of positive cells
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline and 4 weeksPopulation: Tissue biomarker expression according to the treatment arms and the timepoints in normal tissue and dysplasia
Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia
Outcome measures
| Measure |
Experimental Arm
n=15 Participants
Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days
|
Control Arm
n=14 Participants
Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die
|
|---|---|---|
|
Change in Biomarkes Expression
NFKβ Post-treatment: Normal tissue
|
42.3 percentage of positive cells
Standard Deviation 31.7
|
50.7 percentage of positive cells
Standard Deviation 26.7
|
|
Change in Biomarkes Expression
NFKβ Pre-treatment: Normal tissue
|
36.7 percentage of positive cells
Standard Deviation 21.3
|
52.7 percentage of positive cells
Standard Deviation 20.9
|
|
Change in Biomarkes Expression
NFKβ Pre-treatment: Dysplasia
|
69.7 percentage of positive cells
Standard Deviation 17.2
|
74.3 percentage of positive cells
Standard Deviation 15
|
|
Change in Biomarkes Expression
NFKβ Post-treatment: Dysplasia
|
74.3 percentage of positive cells
Standard Deviation 21.5
|
81.4 percentage of positive cells
Standard Deviation 13.5
|
|
Change in Biomarkes Expression
Ki-67 Pre-treatment: Normal tissue
|
19.4 percentage of positive cells
Standard Deviation 14.6
|
21.2 percentage of positive cells
Standard Deviation 11.4
|
|
Change in Biomarkes Expression
Ki-67 Post-treatment: Normal tissue
|
16.1 percentage of positive cells
Standard Deviation 11.1
|
15.9 percentage of positive cells
Standard Deviation 10.5
|
|
Change in Biomarkes Expression
Ki-67 Pre-treatment: Dysplasia
|
44.9 percentage of positive cells
Standard Deviation 26.4
|
42.9 percentage of positive cells
Standard Deviation 19.5
|
|
Change in Biomarkes Expression
Ki-67 Post-treatment: Dysplasia
|
58.0 percentage of positive cells
Standard Deviation 26.0
|
58.2 percentage of positive cells
Standard Deviation 23.6
|
|
Change in Biomarkes Expression
P53 Pre-treatment: Normal tissue
|
8.7 percentage of positive cells
Standard Deviation 11.4
|
3.5 percentage of positive cells
Standard Deviation 4.8
|
|
Change in Biomarkes Expression
P53 Post-treatment: Normal tissue
|
3.9 percentage of positive cells
Standard Deviation 4.4
|
5.4 percentage of positive cells
Standard Deviation 7.3
|
|
Change in Biomarkes Expression
P53 Pre-treatment: Dysplasia
|
50.0 percentage of positive cells
Standard Deviation 24.2
|
37.5 percentage of positive cells
Standard Deviation 20.5
|
|
Change in Biomarkes Expression
P53 Post-treatment: Dysplasia
|
60.3 percentage of positive cells
Standard Deviation 27.7
|
51.8 percentage of positive cells
Standard Deviation 24.1
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Arm
n=15 participants at risk
Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days
|
Control Arm
n=14 participants at risk
Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/15 • 4 weeks
|
7.1%
1/14 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place