BCM95 Clinical Research

 

  • Joint Health Support

    Medical Journal: Molecular Medicine Reports

    Year: 2011; 8(5):1542-8

    Authors: Kizhakkedath, et al.

    A formulation containing Curcuma longa (BCM95) and Boswellia serrata (Bospure) extracts was evaluated for safety and efficacy in subjects and directly compared with a selective COX-2 inhibitor. In total, 54 subjects were screened, 30 subjects were enrolled and 28 completed the study. The treatment was well tolerated and did not produce any adverse effect in subjects, as judged by the vital signs, hemogram, liver and renal function tests. The formulation at 500 mg administered twice a day, was more successful than administration of the COX-2 inhibitor (100 mg twice a day) for symptom scoring and clinical examination. The formulation was found to be safe and no dose-related toxicity was found.

    Medical Journal: Phytotherapy Research

    Year: 2012; 26(11):1719-25

    Authors: Chandran, et al.

    This pilot clinical study evaluated the safety and effectiveness of curcumin alone, and in combination with an NSAID. Forty-five subjects were randomized into three groups with subjects receiving Curcumin BCM-95 (500 mg) and NSAID (50 mg) alone or their combination. The primary and secondary endpoints were reduction in (DAS) 28 Score and ACR score, assessments used by clinicians that measures various joint-related parameters. Subjects in all three treatment groups showed statistically significant changes in their DAS scores. Interestingly, the Curcumin group showed the highest percentage of improvement in overall DAS and ACR scores (ACR 20, 50 and 70) and these scores were significantly better than the subjects in the NSAID group. More importantly, curcumin treatment was found to be safe and did not relate with any adverse events.

    Medical Journal: European Journal of Physical and Rehabilitation Medicine

    Year: 2016; 52(3):321-30.

    Authors: Sterzi, et al.

    In a multicenter, prospective, randomized, double blind, placebo-controlled clinical trial, commercially available dietary supplement CartiJoint Forte was used to assess efficacy and safety of this supplement combined with physical therapy in subjects with knee osteoarthritis (OA). The dietary supplement CartiJoint Forte contains glucosamine hydrochloride (GH), chondroitin sulfate (CS) and Bio-Curcumin BCM-95®. Fifty-three patients were randomly assigned to an experimental group (N=26) or a control group (N=27). The two groups both received 20 sessions of physical therapy during the course of the trial. Primary outcome was pain intensity, measured both at motion and at rest, using the Visual Analogue Scale (VAS). A secondary outcome was an assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and Lequesne Index, knee ROM, and two inflammation markers (C-reactive protein and erythrocyte sedimentation rate). The authors concluded that CartiJoint Forte, added to physical therapy, may help to support healthy joints.

  • Urinary Health Support

    Medical Journal: Journal Cancer Science Therapy

    Year: 2013; 5(10): 320-324

    Authors: Hejazi, et al.

    Some previous in vitro and in vivo studies have proposed a radioprotective role for curcumin, the yellow pigment of turmeric. The purpose of this investigation was to assess the radioprotective effects of curcumin supplementation in subjects undergoing external beam radiotherapy (EBRT) were randomly assigned to curcumin group, taking 3 g/d curcumin (6 × 500 mg capsules of BCM95 n=20), or placebo group (n=20). Quality of life was assessed by the quality of life questionnaire (QLQ-PR25). Analysis of covariance was used to compare radiotherapy related symptoms between groups following the intervention, adjusted for baseline symptoms. No differences in urinary symptoms, bowel symptoms, treatment related symptoms and sexual activity were observed between the curcumin and placebo groups before the intervention. The change in urinary symptoms across the 20-week period differed significantly between groups (p=0.011) and subjects in the curcumin group experienced much milder urinary symptoms compared with the placebo group. No group differences were observed in any other domain of the QLQ-PR25. Curcumin can confer radioprotective effect in through reducing the severity of radiotherapy related urinary symptoms.

     

  • Mood and Stress Support

    Medical Journal: Acta Pol Pharm

    Year: 2011; 68(5): 769-75

    Authors: Sanmukhani, et al

    Curcumin is the active ingredient of commonly used spice Curcuma longa Linn. In the present study, the mood-modulating activity of curcumin (BCM-95®) and its combination with SSRIs was studied in acute model (three doses 24, 5 and 1 h before test) of forced swimming test (FST) in glass jar and tail suspension test (TST) in mice and in chronic model (14 day study) of FST with water wheel in rats. All the tests were carried out in the following seven groups (n = 6 in each group), administered orally (doses for mice): Both the acute model of FST and TST, and the chronic model of FST with water wheel showed significant activity of curcumin in 100 mg/kg dose as compared to vehicle control (p < 0.05). The effect of curcumin (100 mg/kg) was similar to that of SSRIs (p > 0.05) but its addition to SSRIs did not improve their activity (p >0.05). Curcumin increased both the swimming and climbing behavior in FST, thus its mood-modulating activity could be due to an increase in serotonin, norepinephrine and dopamine levels in the brain. Curcumin can be a useful mood-modulator especially in cases which respond to drugs having mixed effects on serotonin and catecholamines levels in the brain.

    Medical Journal: Phytotherapy Research

    Year: 2014; 28:579-585

    Authors: Sanmukhani, et al.

    A randomized comparative human clinical study was done to evaluate the effect of curcumin on mood. Sixty subjects were randomized to receive 20 mg/d of a SSRI (n=20), 500 mg BCM-95® (n=20), and SSRI plus BCM-95® (n=20) for 6 weeks. The 17-item Hamilton Rating Scale (HAMD-17) was the primary efficacy measurement. CGI-S was the secondary efficacy measure. Overall compliance by the study participants was excellent. The proportion of responders as measured by the HAM-D17 scale was higher in the combination group (77.8%) than in the SSRI (64.7%) and the curcumin (62.5%) groups; however, these data were not statistically significant (P = 0.58). Interestingly, the mean change in HAM-D17 score at the end of six weeks was comparable in all three groups (P = 0.77).

    Medical Journal: Journal of Effective Disorders

    Year: 2017; 207:188-196

    Authors: Lopresti,  et al

    Several studies have demonstrated the healthy mood support effects of curcumin (from the spice turmeric) and saffron. In a randomised, double-blind, placebo-controlled study, 123 individuals were allocated to one of four treatment conditions. It was concluded that differing doses of curcumin and combined curcumin/saffron were effective in supporting healthy mood function.

     

  • Cognitive Function Support

    Medical Journal: Journal of Psychopharmacology

    Year: 2008; 28(1):110-114

    Authors: Baum, et al.

    Thirty-four subjects were eligible for this double-blind, placebo-controlled, randomized, 6-month trial if they were 50 years old or older, ethnic Chinese in Hong Kong, had progressive decline in memory and cognitive function for 6 months, and had met NINCDS-ADRDA criteria. Subjects were randomized in 3 Groups each taking 4 grams of placebo, 1 gram of bioavailable Curcumin (BCM-95®) and 4 grams of Conventional Curcumin Extract. At 0, 1 and 6 months plasma was taken to measure antioxidants and serum to monitor AB and liver and kidney functions. Over 1 month, Vitamin E levels in plasma were significantly increased in bioavailable Curcumin group compared to others. Moreover, subjects taking bioavailable Curcumin had greater levels of curcuminoids than the other. Serum beta-Amyloids tended to rise possibly reflecting an ability of Curcumin to disaggregate beta-Amyloids deposits in the brain, releasing them for circulation and disposal. There were no side effects reported in highly bioavailable Curcumin group, rather there were few adverse events on conventional Curcumin group.

  • Healthy Inflammatory Response Support

    Medical Journal: British Journal Nutrition

    Year: 2011; 106(Suppl1):S198-201

    Authors: Leray, et al.

    Among obesity-associated disorders, low-grade inflammation has been described. The putative therapeutic properties of citrus and Curcumin polyphenols could be associated with their anti-inflammatory properties. Two diets supplemented either with hesperidin (0•05 %) and naringin (0•1 %) from citrus extract or with highly bioavailable Curcumin (BCM-95®) from Curcuma longa extract (0•09 %) were fed to eight obese cats for two 8-week periods (cross-over study design) while maintaining animals in an obese state. Plasma acute-phase protein (APP; a1-acid glycoprotein (AGP), serum amyloid A and ptoglobin) levels were assessed before and at the end of each test period. TNFa, IL-1b, IL-2, IL-4, IL-5, IL-10, IL-12, IL-18, transforming growth factor-b, interferon (IFN)-g mRNA levels were determined in peripheral blood mononuclear cells (PBMC) by real-time PCR. Compared with pre-study values, supplementation with citrus polyphenols resulted in lower plasma AGP and haptoglobin concentrations, while that with curcumin resulted in lower plasma AGP concentration. There were no differences between the supplementations. TNF-a, IL-1b, IL-4, IL-5, IL-10, IL-12, IL-18, transforming growth factor-b, mRNA levels remained unaffected by either dietary supplementation. In contrast, IFN-g and IL-2 mRNA levels were lower at the end of the citrus and the curcumin supplementation, respectively. There were no differences between the supplementations. The present study results show a slight effect of citrus and curcumin supplementation on inflammatory markers expressed by PBMC, and a decreased concentration of APP, which are mainly expressed by the liver. This would confirm that hesperidin and naringin or highly bioavailable curcumin extract have beneficial effects, targeted in the liver and could improve the obesity-related inflammatory state.

    Medical Journal: Journal of Equine Vet Science

    Year: 2012; 32(12):805-815

    Authors: Horohov, et al.

    The inflammatory response to vigorous exercise ranges from the mild symptoms of delayed-onset muscle soreness to debilitating injuries affecting soft tissue, joint, and bone. Although there is a great deal of information available on the inflammatory response to exercise in human athletes, less information is available regarding the inflammatory response to exercise in young horses undergoing training for racing careers. Here, we assessed the cytokine response to exercise in a group of young Thoroughbred racehorses during their initial training. Because there is interest in nonpharmacologic approaches to control or ameliorate exercise-induced inflammation, we also examined the anti-inflammatory effect of a nutritional supplement fed to half of the horses undergoing training. Twenty-five Thoroughbred horses aged 2 years were followed through their initial race training. Peripheral blood samples were collected at various times during the exercise for the quantitation of lactic acid, oxidative stress, and inflammatory cytokine gene expression. There was an intensity-dependent effect of exercise on lactate, malondialdehyde, and proinflammatory cytokine gene expression. Although training itself was associated with an overall reduction in inflammatory markers, horses receiving the supplement exhibited further reductions in their indicators of inflammation. As such, this study provides novel evidence of nutritional supplementation reducing post-exercise inflammation. The nutritional supplement consist of formulation made from BCM-95®, BosPure, HydroQSorb, Glycocarn and d-Ribose was fed to the horses twice daily with meals provided everyday throughout the study period. Although exercise-induced changes in cytokine gene expression have been widely studied using treadmill-based exercise tests, the cytokine response to race training had not been investigated in Thoroughbred racehorses. Here, the exercise under race training conditions is associated with the temporal induction of cytokines characteristic of the initial elevation in LAK cell activity immediately after exercise and the subsequent expression of proinflammatory cytokines 2 hours later. These time- and intensity-dependent changes in cytokine gene expression parallel data from previous studies using treadmill-based exercise testing. There were signs of adaptation to exercise over the training period as indicated by an overall reduction in the expression of proinflammatory cytokines and increased expression of IL-6. Although dietary supplements have been used in horses in the past for various reasons, including performance enhancement, their effect on race training has not been investigated. The nutritional supplement used in this study was associated with an enhanced adaptation to exercise in terms of a significant reduction in proinflammatory cytokine expression before and after exercise. This underscores the potential for nutritional supplementation to reduce exercise-induced inflammatory pathologies in racehorses.

     

    Medical Journal: Pharmacognosy Journal

    Year: 2016, 8,4,380-384

    Author: Vinaykumar, et al.

     

    Anti-inflammatory activity of bio-enhanced turmeric formulation (BCM-95) was compared with commercial Curcumin formulation (Curcuminoids 95%) in Carrageenan-induced acute inflammatory model. Thirty-Six Wistar rats were divided into six groups-Normal control, Standard control, 2 doses of BCM 95 (10 and 20 mg/kg) and Curcuminoids 95% (10 and 20 mg/kg. Difference between groups was analyzed with ANOVA followed by Tukey test. In this study, all treatment groups demonstrated significant (p<0.05) anti-inflammatory activity. The authors concluded that BCM 95 treated groups showed significant healthy inflammatory response support compared to Curcuminoid 95% treated groups.

  • Bioavailability Studies

    Medical Journal: Ind Journal of Pharmaceutical Science

    Year: 2008; 70(4):445-449

    Authors: Antony, et al.

    Curcumin, the bioactive component of turmeric, Curcuma longa has an exceptionally wide spectrum of health-promoting activities. However, although in vitro and animal studies have shown reported beneficial activities of curcumin, its poor bioavailability in the human body has severely limited its application. Methods to increase its oral bioavailability are a subject of intense current research. Reconstituting curcumin with the noncurcuminoid components of turmeric has been found to increase the bioavailability substantially. In the present clinical study to determine the bioavailability of curcuminoids, 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-lecithinpiperine which was earlier shown to provide enhanced bioavailability. The results of the study indicate that the relative bioavailability of BCM-95®CG (BCM-95) was about 6.93-fold compared to normal curcumin and about 6.3-fold compared to curcumin.

    Medical Journal: Journal of Functional Foods

    Year: 2010; 2(1):60-65

    Authors: Sishu, et al.

    The bioavailability of curcumin from turmeric, BCM-95® and as plain curcumin was investigated using conventional vehicles by a non-everted rat intestinal model. Results of ex vivo intestinal permeability studies showed an enhancement in the permeability of curcumin with increase in lipophilicity of the vehicle used. Maximum permeability of curcumin was obtained from corn oil (13.4%) followed by clarified butter (9.82%), milk (4.24%) and aqueous suspension (1.66%) in 8 h. Another very interesting and important observation was that the permeation of curcumin was more from BCM-95® than from plain curcumin. These studies strongly suggest that curcumin may be consumed as turmeric/BCM-95® in lipophilic vehicles instead of plain curcumin for maximum beneficial effects.

  • Prostate Health

    Medical Journal: Integrative Cancer Therapy

    Year: 2010; 9(2):186-96

    Authors: Katz, et al.

    ProstaCaid, a novel integrative blend of vitamins, minerals, multi-herb extracts, and derivatives, were tested in human and mouse androgen–dependent (AD) and –independent (AI) prostate cell lines. BCM-95® is a major ingredient in Prostacaid. ProstaCaid shows growth inhibitory effects on both human and mouse AD prostate cells (LNCaP and CASP 2.1) and AI prostate cells (PC3 and CASP 1.1) in a dose-/time-dependent manner. Consistently, long-term treatment with ProstaCaid also reduced colony formation capacities these cells. Flow cytometry assays revealed that ProstaCaid induces G2/M arrest and apoptosis in LNCaP and PC3 cells after 72 hours of treatment. Immunoblotting assay demonstrated that 25 mg/mL of ProstaCaid treatment resulted in (1) the reduction of cyclin D1, cyclin B1, and Cdc2 expression in a time-dependent way; (2) increase in p21WAF1/Cip1 as early as 12 hours after the treatments in PC3 cells and reduction to base line at the 72-hour time point; and (3) repression of Bcl-2, BclxL, and induction of Bim as well as the cleavages of caspase-3 and poly(ADP-ribose) polymerase (PARP) at 72 hours of treatment, suggesting caspase-3-dependent apoptosis. Moreover, ProstaCaid suppressed activation of AKT and MAPK signaling pathways in PC3 and LNCaP cells by reducing phosphorylation levels of AKT, its downstream target S6 ribosomal protein and GSK3b, and ERK1/2, respectively. In summary, these findings strongly suggest that ProstaCaid may be a potential therapeutic agent for prostate health.

    Medical Journal: International Journal of Oncology

    Year: 2011; 38:1675-1682

    Authors: Jiang, et al.

    In the present study we have evaluated the r effects of dietary supplement ProstaCaid™ (PC) which contains mycelium from medicinal mushrooms (Ganoderma lucidum, Coriolus versicolor, Phellinus linteus), saw palmetto berry, pomegranate, pumpkin seed, green tea [40% epigallocatechin-3-gallate (EGCG)], Japanese knotweed (50% resveratrol), extracts of turmeric root (BCM-95®), grape skin, pygeum bark, sarsaparilla root, Scutellaria barbata, eleuthero root, Job’s tears, astragalus root, skullcap, dandelion, coptis root, broccoli, and stinging nettle, with purified vitamin C, vitamin D3, selenium, quercetin, citrus bioflavonoid complex, ß sitosterol, zinc, lycopene, alpha lipoic acid, boron, berberine and 3.3′-diinodolymethane (DIM). We show that PC treatment resulted in the inhibition of cell proliferation of the human hormone refractory (independent) PC-3 prostate cells in a dose- and time-dependent manner with IC50 56.0, 45.6 and 39.0 μg/ml for 24, 48 and 72 h, respectively. DNA microarray analysis demonstrated that PC inhibits proliferation through the modulation of expression of CCND1, CDK4, CDKN1A, E2F1, MAPK6 and PCNA genes. In addition, PC also suppresses behavior of PC-3 by the inhibition of cell adhesion, cell migration and cell invasion, which was associated with the down-regulation of expression of CAV1, IGF2, NR2F1, and PLAU genes and suppressed secretion of the urokinase plasminogen activator (uPA) from PC3 cells. In conclusion, the dietary supplement PC is a promising natural complex for support of prostate health.

  • Breast Health Support

    Medical Journal: Integrative Cancer Therapies

    Year: 2011; 10(2):192-20

    Authors: Jiang, et al.

    The study was to evaluate the effect of the dietary supplement BreastDefend (BD) on the proliferation and invasive behavior in MDA-MB-231 breast cells treated with BD (0-40 μg/mL) by MTT assay and trypan blue staining, respectively. Expression of cell cycle regulatory genes were determined by DNA-microarray analysis. Effect of BD on invasiveness was assessed by cellular adhesion, migration, and invasion assays. BCM-95® is a major ingredient in BD. BD treatment of cells MDA-MB-231 resulted in the cytostatic inhibition of cell proliferation with IC50 22.2, 19.1, and 17.5 μg/mL for 24, 48, and 72 hours, respectively. The inhibition of proliferation was mediated by the upregulation expression of CCNG1, CHEK1, CDKN1C, GADD45A, and E2F2, whereas BD down regulated expression of CCNA1 and CDK6 genes. The induction of expression of GADD45A and inhibition of expression of cyclin A1 (gene CCNA1) by BD was also confirmed on the protein level. BD treatment suppressed the invasive behavior of MDA-MB-231 cells by the inhibition of cellular adhesion, migration, and invasion. This inhibition of invasiveness was mediated by the suppression of secretion of urokinase plasminogen activator (uPA), and by the down regulation of expression of CXCR4 in breast cancer cells treated with BD. Conclusion: BD inhibits proliferation and invasive behavior of MDA-MB-231 cells in vitro. BD may have a therapeutic potential for breast health support.

  • Liver Support

    Poster presented at IPSCON 44th Annual Conference of Indian Pharmacological Society, 2011 The study evaluated hepatoprotective activity of combination of Phyllanthus niruri and Curcuma longa extracts (BCM95®) against CCl4 induced hepatotoxicity. Wistar rats weighing 150-200 g were divided into 3 groups (n=6). Group I- Control, Group II-CCl4 (0.5 mg/kg i.p), Group III- CCl4 (0.5 mg/kg i.p) with PN+CL (400 mg/kg) were administered for 7 days. On 8th day, Serum Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) and Total bilirubin (TB) were estimated. Histopathological assessment was done using liver tissue. Analysis was done using one way ANOVA. Results: There was a significant increase in serum enzymes-AST (58.86±2.33), ALT (28.01 ± 1.14), ALP (77.99± 1.85) and TB (2.08± 0.08) levels in CCl4 treated rats compared to control animals. Co administration of PN+CL extracts combination with CCl4 significantly prevented the rise in AST(29.37±1.81), ALT (12.57± 0.93), ALP (60.62± 1.37) and TB (1.18± 0.07) levels. Histological section of liver in animals treated with CCl4 showed centrilobular area of necrosis with derangement in hepatic architecture. PN+CL administration prevented these deleterious changes, histological section of liver in rats treated with PN+CL showed normal hepatic parenchyma. Combination of Phyllanthus niruri + Curcuma longa extracts showed significant hepatoprotection against CCl4 induced liver damage.

  • In vitro studies with BCM-95®

    Medical Journal: PLOS One

    Year: 2014; 9(1):1-11

    Authors: Shakibael, et al.

    This in vitro study investigated the effectiveness of 5-FU and plant polyphenol (curcumin) in context of DNA mismatch repair (MMR) status and CSC activity in 3D cultures of CRC cells. High density 3D cultures of CRC cell lines HCT116, HCT116+ch3 (complemented with chromosome 3) and their corresponding isogenic 5-FU-chemo-resistant derivative clones (HCT116R, HCT116+ch3R) were treated with 5-FU either without or with curcumin in time- and dose-dependent assays. Pre-treatment with BCM-95® significantly enhanced the effect of 5-FU on HCT116R and HCR116+ch3R cells, in contrast to FU alone as evidenced by increased disintegration of colonospheres, enhanced apoptosis and by inhibiting their growth.

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