A Novel Curcumin-Galactomannoside Complex Delivery System Improves Hepatic Function Markers in Chronic Alcoholics: A Double-Blinded, randomized, Placebo-Controlled Study

Abstract

Considering the recent interest in free (unconjugated) curcuminoids delivery, the present study investigated the efficacy of a novel food-grade free-curcuminoids delivery system (curcumin-galactomannoside complex; CGM) in improving the hepatic function markers (inflammation and oxidative stress) in chronic alcoholics. The double-blinded, placebo-controlled study randomized 48 subjects with elevated serum transaminases and gamma-glutamyl transferase (GGT) levels, who were allocated to two groups (n=24) and to receive either placebo or CGM at (250 mg × 2)/day for 8 weeks. While liver function markers (transaminases and GGT) in the placebo group showed an increase (~ 9.5%), CGM group indicated a significant decrease in transaminases (31%) and GGT (29%) from the baseline levels. The beneficial effect of CGM was also clear from the significant increase (p <0.001) in endogenous antioxidants (GSH, SOD, and GPx) and decrease in inflammatory markers (IL-6 and CRP) levels (p <0.001) as compared to both the baseline and placebo group. To summarize, the nutritional intervention of CGM-curcumin was found to offer a significant hepatoprotective effect to attenuate the alcohol induced alterations to hepatic function markers. The Indian Medical Council and Drug Controller General of India approved Clinical Trial Registry No. CTRI/2018/03/012385.

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“…CGM did not induce any adverse effects in the treated subjects during the study period that further support its earlier safety reports at dosages 500 –1,000 mg/day (Krishnareddy et al, 2018). Oral administration of CGM has already been proven as extremely safe and was validated to have no observable adverse effect level (NOAEL) up to 2000 mg/kg b. wt.…”

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“…Once swell in the gastrointestinal tract, CGM has been shown to act as a self-emulsifying hydrogel with high mucoadhesive character, capable of delivering amphiphilic colloidal curcumin particles that can be absorbed quickly. CGM has already demonstrated its superior efficacy in a relatively low dosage [ [32] , [33] , [34] ], with improved brain bioavailability as revealed by its influence on brain waves [ 35 ], radioprotective [ 36 ] and neuroprotective effects [ 37 , 38 ]. CGM was reported to exhibit 45-fold enhancement in the bioavailability of free curcuminoids and 270-fold enhancement in the bioavailability of total curcuminoids (sum of conjugated and unconjugated), when compared to an equivalent dose of unformulated standard curcuminoids with 95 % purity [ 31 ].…”

“…Curcumin was also found to reduce heavy metal-induced hepatotoxicity by preventing histological injury, lipid peroxidation and mitochondrial dysfunction and maintaining liver antioxidant enzyme status [ 45 ]. Supplementation of CGM at 250 mg × 2 /day has been shown to attenuate the elevated liver function enzyme markers among chronic alcoholics in 28 days [ 33 ]. Further studies on alcohol-induced cirrhotic model of rats confirmed the hepatoprotective effect of CGM through modulation of TLR4/MMP expression and hepatic cellular regeneration [ 46 ].…”