Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths in the United States. A safe and effective preventive agent could reduce the burden of colorectal cancer as well as reduce the costs associated with screening patients who are at high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active against multiple pathways implicated in tumor initiation, progression, and metastasis. However, little is know how curcumin performs in humans. The investigators propose to enroll 12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin administration. The investigators will look at curcumin preparations with low and high oral bioavailability and calculate the blood and rectal tissue concentrations associated with these two formulations to determine which preparation produces the highest tissue concentrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
12
standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
UNC Department of Family Medicine
Chapel Hill, North Carolina, United States
AUC
Area under plasma concentration curve from 0-48h using 13 time points.
Time frame: 0-48h
Cmax
Maximum curcumin plasma concentration
Time frame: 0-48h
Tmax
Time to maximum curcumin plasma concentration
Time frame: 0-48h
Ke
Terminal elimination rate
Time frame: 0-48h
T1/2
plasma curcumin concentration half-life
Time frame: 0-48h
Vd
Volume of distribution
Time frame: 0-48h
Test of bioequivalence
geometric mean ratio of plasma AUC0-48h of the two formulations
Time frame: 0-48h
bioequivalence of tissue curcumin concentration
comparison of curcumin concentration in colorectal tissue at single time point between two formulations
Time frame: 1h
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