Published Studies - BCM-95®

BCM-95^® has been the subject of published human bioavailability studies, as well as clinical trials demonstrating support for mental health and brain function, and blood lipids.*1-6 New studies that are in progress, or recently completed but not yet published, will continue to explore curcumin’s benefits in these areas as well as consider its use in support of the immune system, joint health, and other applications.*^7-10

Published Research

1. Benny B, Antony B. Bioavailability of Biocurcumax (BCM-95). (Spice India. September, 2006:11-15.)

Curcuminoids are the yellow colouring matter, the most active molecules of turmeric (Curcuma longa) one of the familiar spices possessing numerous bioactive components. But it is suggested and proved that the total curcuminoids absorbed by animal systems is limited to 50-60%. Biocurcumax (BCM-95) is a unique blend which enhances the bioavailability of curcumin. The study described here reveals the bioavailability of BCM-95 in human volunteers.

2. Antony B, Merina B, Iyer VS, Judy N, Lennertz K, Joyal S. A pilot cross-over study to evaluate human oral bioavailability of BCM-95, a novel bioenhanced preperation of curcumin. (Ind J Pharm Sci. 2008:445-450)

Curcumin, the bioactive component of turmeric, Curcuma longa has an exceptionally wide spectrum of activities including antioxidant, anti-infl ammatory and anti-cancer properties, and is currently under different phases of clinical trials for various types of soft tissue cancers. However, although in vitro and animal studies have shown anticancer activities of curcumin for virtually all types of human cancers, its poor bioavailability in the human body has severely limited its application to these diseases. Methods to increase its oral bioavailability are a subject of intense current research. Reconstituting curcumin with the non-curcuminoid components of turmeric has been found to increase the bioavailability substantially. In the present clinical study to determine the bioavailability of curcuminoids, a patented formulation, BCM-95^®CG was tested on human volunteer group. Normal curcumin was used in the control group. Curcumin content in blood was estimated at periodical intervals. After a washout period of two weeks the control group and drug group were crossed over BCM-95^®CG and curcumin, respectively. It was also compared with a combination of curcumin-lecithin-piperine which was earlier shown to provide enhanced bioavailability. The results of the study indicate that the relative bioavailability of BCM-95^®CG (Biocurcumax^TM) was about 6.93-fold compared to normal curcumin and about 6.3-fold compared to curcumin-lecithin-piperine formula. BCM-95^® thus, has potential for widespread application for various chronic diseases.

3. Baum L, Lam CWK, Cheung SKK, et al. Six-month randomized, placebo-controlled, double-blind, pilot clinical trial of curcumin in patients with Alzheimer disease (J Clin Psychopharmacology 2008; 28(1):110-114)

As the first study published on curcumin treatment of Alzheimer’s (AD) patients, this trial provided data on side effects, drug absorption, and biological effects. Curcumin may act in AD by several possible mechanisms, including amyloid beta disaggregation, anti-inflammation, and antioxidation. The lack of cognitive decline on placebo in this 6-month trial may have precluded any ability to detect a relative protective effect of curcumin, which presumably would have appeared as a slower decline rather than an improvement in cognition. A study of longer duration, with a more sensitive test such as the Alzheimer Disease Assessment Scale–cognitive subscale and perhaps less treatment by other AD drugs, may show greater deterioration on placebo. The greater level of curcumin but not tetrahydrocurcumin, ferulic acid, or vanillic acid after capsules than powder may be due to more absorption and less metabolism of curcumin from capsules, suggesting that capsules be used in future trials. The lack of difference in curcumin or metabolite levels between 1- and 4-g groups suggests that there may be no need to exceed 1 g in future trials. Curcumin prevents or reverses half of the aggregation (IC50) of amyloid beta at 0.2 to 1 2M bisdemethoxycurcumin (CDB). In this study, mean plasma CDB was 490 nM (940 nM for capsules).

4. Curcumin effects on blood lipid profile in a 6-month human study (Elsevier Pharmacological Research. 2007;56:509-514.

Studies in animals and a short-term human study have suggested that curcumin, a polyphenolic compound concentrated in the curry spice turmeric, decreases serum cholesterol concentration. However, no controlled human trials have examined the effect of curcumin on cholesterol. This study investigated the effects of consuming curcumin on the serum lipid profile in men and women. Elderly subjects (n = 36) consumed 4 g/d curcumin, 1 g/d curcumin, or placebo in a 6-month, randomized, double-blind trial. Plasma curcumin and its metabolites were measured at 1 month, and the serum lipid profile was measured at baseline, 1 month, and 6 months. The plasma curcumin concentration reached a mean of 490 nmol/L. The curcumin concentration was greater after capsule than powder administration. Consumption of either dose of curcumin did not significantly affect triacylglycerols, or total, LDL, and HDL cholesterol over 1 month or 6 months. However, the concentrations of plasma curcumin and serum cholesterol were positively and significantly correlated. Curcumin consumption does not appear to have a significant effect on the serum lipid profile, unless the absorbed concentration of curcumin is considered, in which case curcumin may modestly increase cholesterol.

Un-Published Studies:

5. Comparative human bioavailability evaluation of BCM-95.

6. Human bioavailability of Curcu-Gel Softgels containing BCM-95.

Current Studies Under Peer Review for Publication:

7. Randomized, controlled human clinical study to assess the efficacy and safety of BCM-95^® & BosPure^® in the management of knee osteoarthritis.

8. Randomized, controlled human clinical study to assess the efficacy and safety of BCM-95 in the management of active rheumatoid arthritis.

9. Oral bioavailability of BCM-95 in dogs.

Clinical Study in Progress

10. Phase II randomized, double-blind, placebo chemoprevention clinical trial of curcumin in oral premalignant lesions and cervical cancer.