Journal of Clinical Psychopharmacology:
doi: 10.1097/JCP.0000000000000508
Original Contributions
Pandaran Sudheeran, Subash MSc; Jacob, Della MSc; Natinga
Mulakal, Johannah MSc; Gopinathan Nair, Gopakumar MPhil, PhD; Maliakel,
Abhilash MSc; Maliakel, Balu PhD; Kuttan, Ramadasan PhD; IM,
Krishnakumar PhD
Supplemental Author Material
Abstract
Abstract: Drug delivery systems capable of delivering
free (unconjugated) curcuminoids is of great therapeutic significance,
since the absorption of bioactive and permeable form plays a key factor
in mediating the efficacy of a substance which undergoes rapid
biotransformation. Considering the recent understanding on the
relatively high bioactivities and blood-brain–barrier permeability of
free curcuminoids over their conjugated metabolites, the present human
study investigated the safety, antioxidant efficacy, and bioavailability
of CurQfen (curcumagalactomannoside [CGM]), a food-grade formulation of
natural curcumin with fenugreek dietary fiber that has shown to possess
improved blood-brain–barrier permeability and tissue distribution in
rats. In this randomized double-blinded and placebo-controlled trial, 60
subjects experiencing occupational stress-related anxiety and fatigue
were randomized to receive CGM, standard curcumin, and placebo for 30
days (500 mg twice daily). The study demonstrated the safety, tolerance,
and enhanced efficacy of CGM in comparison with unformulated standard
curcumin. A significant improvement in the quality of life (P < 0.05) with considerable reduction in stress (P < 0.001), anxiety (P < 0.001), and fatigue (P
< 0.001) was observed among CGM-treated subjects as compared with
the standard curcumin group, when monitored by SF-36, Perceived Stress
Scale with 14 items, and Beck Anxiety Inventory scores. Improvement in
the quality of life was further correlated with the significant
enhancement in endogenous antioxidant markers (P < 0.01) and reduction in lipid peroxidation (P
< 0.001). Further comparison of the free curcuminoids
bioavailability after a single-dose (500 mg once per day) and
repeated-dose (500 mg twice daily for 30 days) oral administration
revealed enhanced absorption and improved pharmacokinetics of CGM upon
both single- (30.7-fold) and repeated-dose (39.1-fold) administrations.
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