N/A
N=35
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
Colorectal Adenoma · Risk Reduction
Bottom Line
View on ClinicalTrials.gov: NCT01948661 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Beta Catenin Expression — 100; 100; 100; 100 percentage of positive cells
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mirtoselect® + Meriva® (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ente Ospedaliero Ospedali Galliera
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Beta Catenin Expression |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Change in Biomarkes Expression |
36.7; 52.7; 42.3; 50.7; 69.7; 74.3 | — |
Summary
It has been shown that curcumin and cyanidin-3-glucoside (C3G) have anticancer effects. In this clinical trial we compare the affect of their combination vs placebo in a four weeks intervention before endoscopic polypectomy.
Eligibility Criteria
Inclusion criteria
- Subjects with colorectal adenomatous polyps greater than 1 cm in maximum diameter not suitable to immediate complete removal;
- Normal renal and hepatic function;
- WHO Performance status=0;
Exclusion Criteria
- Presence of hyperplastic polyps and/or flat adenomas;
- Subjects with pre-existing colorectal cancer;
- Presence of carcinomatous tissue in adenoma;
Data sourced from ClinicalTrials.gov (NCT01948661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.