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Obesity is a significant public health concern, and finding safe and effective means for combating this condition is needed. This study investigates the safety and efficacy of supplementation of a blend of capsaicinoids on weight gain, fat mass, and blood chemistry in a high‐fat diet (HFD) model of obesity in mice and on adipocyte differentiation and gene expression in 3T3‐L1 preadipocytes. High‐fat diet (HFD)‐fed mice were treated with a proprietary capsaicinoid concentrate (Capsimax®; OmniActive Health Technologies Ltd., India) and compared to orlistat (ORL) and normal chow‐fed mice (NC). Mice fed a high‐fat diet showed significantly lower weight gain upon Capsimax® (CAP) administration than their HFD counterparts and similar to that observed with ORL animals. In addition, CAP decreased the high‐fat diet‐induced increases in adipose tissue and epididymal fat pad mass and hypertrophy after 52 days of treatment. Both the CAP and ORL groups had increased plasma concentrations of leptin. CAP extracts decreased triacylglycerol content in 3T3‐L1 preadipocytes and decreased markers of adipogenesis including peroxisome proliferator‐activated receptor (PPAR‐ɣ) and fatty acid‐binding protein 4 (FABP4). Expression of genes involved in lipogenesis such as stearoyl‐CoA desaturase (SCD) and fatty acid synthase (FSN) was decreased by CAP in a dose‐dependent manner. Thermogenic genes and markers of brown adipose tissue including uncoupling protein 1 (UCP1) and PR domain‐containing 16 (Prdm16) were induced by CAP in the preadipocyte cells. These in vivo and in vitro data support that this proprietary capsaicinoid concentrate reduces weight gain and adiposity at least in part through decreasing lipogenesis and increasing thermogenesis., The present study found that mice fed a high‐fat diet showed significantly lower weight gain upon CAP administration than their control counterparts. In addition, CAP decreased the high‐fat diet‐induced increases in fat mass and increased the circulating leptin levels. In support of these in vivo observations, CAP extracts decreased triacylglycerol content and affected gene expression consistent with increased thermogenesis and decreased lipid accumulation in 3T3‐L1 preadipocytes and adipocytes.

Lutein (L) and zeaxanthin (Z) are carotenoids that are found in the macula of the human eye and are known to improve visual functions. However, poor bioavailability of supplemental L and Z poses a challenge to achieving significant benefits after consumption. We developed a novel patented formulation of L and Z (OcusorbNinety adult human volunteers were recruited in this randomized, double-blind, parallel, comparative bioavailability study. Volunteers were randomly assigned to receive single dose of 10 mg lutein and 2 mg zeaxanthin from test (LZO) or reference (LZC) formulations after breakfast. Blood samples were collected pre-dose at - 48, - 24, and 0 h and at 2, 4, 6, 8, 10, 12, 16, 20, 24, 48, and 72 h post-dose. Serum concentrations of L and Z were quantified by using a validated HPLC method. The LZO and LZC formulations were compared for L and Z on the basis of CAll 90 subjects completed the study. The LZO group demonstrated significantly higher levels of L and Z in serum at several time points as compared to LZC group. The LZO group showed significantly higher bioavailability for lutein (2.5 times higher CThe study results show superior bioavailability of lutein and zeaxanthin from our novel LZO formulation as compared to LZC. The enhanced bioavailability from the LZO formulation can be advantageous for individuals looking to quickly improve their L and Z status and enhance their vision performance.http://ctri.nic.in/ . Identifier: CTRI/2019/11/022082.

Osteoarthritis (OA) is a musculoskeletal disorder mainly found in elderly individuals. Modern treatment of OA, like nonsteroidal anti-inflammatory drugs, corticosteroids, hyaluronic acid injections, etc., is linked to long-term side effects. We evaluated the anti-osteoarthritic properties of a novel joint health formula (JHF) containing Bisdemethoxycurcumin enriched curcumin, 3-O-Acetyl-11-keto-beta-Boswellic acid-enriched Boswellia, and Ashwagandha in monosodium iodoacetate (MIA)-induced knee OA in rats. Twenty-eight female rats were distributed into four groups: Control, OA, OA + JHF (100 mg/kg), and OA + JHF (200 mg/kg). JHF decreased the right joint diameters but increased the paw area and stride length compared to the OA group with no treatment. JHF significantly reduced the arthritic conditions after four weeks of supplementation (p 0.05). JHF significantly decreased TNF-α, IL-1β, IL-10, COMP, and CRP in the serum of osteoarthritic rats (p 0.0001). We observed reduced lipid peroxidation but increased SOD, GSH-Px, and CAT activities in response to JHF treatment in OA animals. JHF down-regulated MMP-3, COX-2, and LOX-5 and improved the histological structure of the knee joint of osteoarthritic rats. JHF demonstrated a protective effect against osteoarthritis, possibly due to anti-inflammatory and antioxidant activity in experimentally induced osteoarthritis in rats, and could be an effective option in the management of OA.

Background: Oral consumption of caffeine typically leads to its instant release and subsequent rapid absorption, high plasma caffeine levels followed by a quick steep decline reducing its beneficial effects which is frequently referred to as “caffeine crash”. To overcome this limitation, we developed a new slow and sustained-release caffeine (SRC) formulation, Xtenergy™. Objectives: The primary objective was to compare the plasma pharmacokinetic profile of SRC with immediate-release caffeine (IRC). Secondary objectives included the use of caffeine research visual analogue scales (Caff - VAS) to evaluate some of the nootropic benefits of SRC and safety assessments. Methods: This was a randomized, double-blind, single-dose, active-controlled, crossover study. Twenty-six subjects were randomized to receive 200 mg caffeine from SRC and IRC in a crossover fashion as per the randomization schedule. Blood samples were collected at -4, 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 h in each period. Plasma caffeine levels were analyzed by a validated LC-MS/MS method. The changes in Caff-VAS relaxed, alert, jittery, tired, tense, headache, overall mood from baseline i.e., 0 to 1, 2, 4, 6, 8, 10, and 12 h were evaluated. Results: Twenty-four male subjects with mean age 32.71±6.18 years completed the study. The median Tmax was 325.53% higher (p

Curcumin positively affects performance during exercise and subsequent recovery. However, curcumin has limited bioavailability unless consumed in larger doses. In the current study, we examined the impact of a new formulation of curcumin, Next-Generation Ultrasol Curcumin (NGUC), which is relatively more bioavailable than natural curcumin on exhaustion time, grip strength, muscle damage parameters, and serum and muscle proteins. A total of 28 rats were randomly grouped as control (C, non-supplemented), exercise (E, non-supplemented), E+NGUC100 (supplemented with 100 mg/kg BW NGUC), and E+NGUC200 (supplemented with 200 mg/kg NGUC). Grip strength and exhaustion time were increased with NGUC supplementation (p &lt, 0.0001). Creatine kinase (CK), lactate dehydrogenase (LDH), lactic acid (LA), myoglobin, malondialdehyde (MDA) concentrations were reduced in serum, and muscle tissue in NGUC supplemented groups (p &lt, 0.05). In contrast, NGUC supplementation elevated the antioxidant enzyme levels compared to the non-supplemented exercise group (p &lt, 0.01). Additionally, inflammatory cytokines were inhibited with NGUC administration (p &lt, 0.05). NGUC decreased PGC-1α, p-4E-BP1, p-mTOR, MAFbx, and MuRF1 proteins in muscle tissue (p &lt, 0.05). These results indicate that NGUC boosts exercise performance while reducing muscle damage by targeting antioxidant, anti-inflammatory, and muscle mass regulatory pathways.

Environmental light pollution due to artificial light may increase the rate and severity of retinal diseases, and plant-based nutritional interventions with antioxidant properties have the potential to reverse this phenomenon. We aimed to investigate the potential effects of allyl isothiocyanate (AITC) against white light-emitting diode (LED)-induced retinal degeneration (RD) in the rats.Twenty-eight male rats were allocated as: (i) Control, (ii) LED, (iii) LED + AITC (10 mg/kg BW), (iv) LED + AITC (20 mg/kg BW). Rats were administered with AITC for 28 days, followed by two days of intense environmental LED light (750AITC lowered the serum and retina malondialdehyde (MDA) levels while significantly (In conclusion, four weeks of AITC administration to the rats showed specific protective effects against two days of intense LED light-induced retinal damage; through antiinflammatory, antioxidant, anti-apoptotic, and modulating mitochondrial metabolic pathways.

OBJECTIVES: Lutein (L) and Zeaxanthin (Z) are the only dietary carotenoids exclusively deposited in the macula and supplementation of these nutrients is associated with visual and cognitive benefits. Ensuring their bioavailability is an important consideration for efficacy. We developed and patented a unique LZ formulation designed for enhanced MC absorption (Test). Our objective was to clinically measure the bioavailability of this Test formulation in comparison to a commercially available formulation (Reference). METHODS: This randomized, double-blind, parallel study involved ninety healthy, adult human volunteers. All subjects stayed within the study facility three days before administration of the study products and three days post-dose. Volunteers consumed a single-dose of the Test or Reference product, each comprising of 10 mg L and 2 mg Z immediately after breakfast. Blood samples were collected prior to dosing @ −48, −24 & 0 hrs and subsequently at 2, 4, 6, 8, 10, 12, 16, 20, 24, 48 and 72 hrs post-dose. L and Z levels were measured in serum using the validated HPLC method. The primary outcomes of the study included Cmax, AUC0–72, AUC0-T. Secondary outcomes included AUC0-12, AUC0-24, AUC0-48, AUC0-inf, Tmax and t1/2. RESULTS: All subjects completed the study with 100% compliance and no drop-outs. Serum L and Z levels were significantly higher in the Test group vs. the Reference group with a 2-fold and 1.5-fold greater absorption of L and Z levels, respectively, at all time points. Cmax, AUC0-72 and AUC0-T for serum L levels were 2.5, 2.9 and 3.2-fold greater, respectively, in the group receiving the Test formula. Similarly, the Cmax, AUC0-72 and AUC0-T for serum Z were also significantly greater with the Test formula. Finally, the Cmax and AUC parameters were significantly higher than the 80–125% criteria established by the FDA for bioequivalence confirming the superior bioavailability of Test product compared to Reference product. CONCLUSIONS: These clinical findings support the superior bioavailability of this novel and uniquely formulated L Z dietary supplement product. The enhanced bioavailability behavior of this proprietary formulation can be advantageous for individuals looking to quickly improve their L and Z status and enhance their vision protection and performance. FUNDING SOURCES: OmniActive Health Technologies.

OBJECTIVES: Obesity is caused by an imbalance between energy intake and energy expenditure. Resting energy expenditure (REE) represents the calories burned at rest and accounts for > 60% of total energy expenditure. Energy expenditure plays an important role in obesity development, hence an increase in REE could facilitate body weight reduction. Capsaicinoids, extracted from capsicum annuum have been known to increase metabolism, lipolysis & induce satiety. The study objective was to evaluate the effects of Capsimax™ on REE and thermal sensation. METHODS: This was a randomized, double-blind, placebo controlled, cross-over study. Efficacy analysis included subsets of 17 males and 7 females who received single dose of Capsimax™ 100 mg (2 mg total capsaicinoids) and placebo in a cross-over fashion with washout period of 3–6 days as per randomization schedule. REE was measured using Cosmed Q-NRG by indirect calorimetry. Secondary objectives were Area under curve (AUC) for REE, VO2, VCO2 & subject's innate thermal sensation using American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) scale. REE, VO2, VCO2, ASHRAE scale were evaluated at 0 (pre-dose), 1, 2, 3 & 4 hours and additional measures for ASHRAE scale at 0.5 & 1.5 hours post-dose. Safety was assessed throughout the study with measurements of ECG, blood pressure, pulse rate, body temperature & adverse event occurrences. RESULTS: In males, Capsimax(TM) consumption significantly increased (p

Osteoarthritis (OA) is a chronic and debilitating disease of the knee joint. OA of the knee is initiated by physical damage and accumulated oxidative stress, followed by an exaggerated inflammation leading to cartilage damage. Currently, no effective and safe therapeutic option capable of restoring articular cartilage tissue and joint architecture is available. We here report a novel and highly bioavailable formulation of curcumin, labeled as Next Generation Ultrasol Curcumin (NGUC), which was 64.7 times more bioavailable than natural 95% curcumin extract as demonstrated in rat bioavailability studies. We further investigated the protective effect of NGUC against monosodium iodoacetate (MIA)‐induced knee OA in rats. Analysis of X-ray and histopathological images revealed that NGUC supplementation restored joint architecture and reduced swelling of joints induced by MIA. NGUC treatment caused a significant reduction in the levels of inflammatory mediators such as TNF-α, IL-1β, IL-6, COMP, and CRP, and expressions of MMP-3, 5-LOX, COX-2, and NFκB in synovial tissue of rats with MIA-induced OA. NGUC also decreased serum MDA level and increased the levels of antioxidant enzymes SOD, CAT, and GPX. Thus, our results indicate that a novel formulation of curcumin with enhanced bioavailability effectively ameliorates the pathophysiology of OA.

Retinal damage associated with loss of photoreceptors is a hallmark of eye diseases such as age-related macular degeneration (AMD) and diabetic retinopathy. Potent nutritional antioxidants were previously shown to abate the degenerative process in AMD. β-Cryptoxanthin (BCX) is an essential dietary carotenoid with antioxidant, anti-inflammatory, and provitamin A activity. It is a potential candidate for developing intervention strategies to delay the development/progression of AMD. In the current study, the effect of a novel, highly purified BCX oral formulation on the rat retinal damage model was evaluated. Rats were fed with BCX for four weeks at the doses of 2 and 4 mg/kg body weight in the form of highly bioavailable oil suspension, followed by retinal damage by exposing to the bright light-emitting diode (LED) light (750 lux) for 48 hrs. Animals were sacrificed after 48 hours, and eyes and blood samples were collected and analyzed. BCX supplementations (2 and 4 mg/kg) showed improvements in the visual condition as demonstrated by histopathology of the retina and measured parameters such as total retinal thickness and outer nuclear layer thickness. BCX supplementation helped reduce the burden of oxidative stress as seen by decreased serum and retinal tissue levels of malondialdehyde (MDA) and restored the antioxidant enzyme activities in BCX groups. Further, BCX supplementation modulated inflammatory markers (IL-1β, IL-6, and NF-κB), apoptotic proteins (Bax, Bcl-2, caspase 3), growth proteins and factors (GAP43, VEGF), glial and neuronal proteins (GFAP, NCAM), and heme oxygenase-1 (HO-1), along with the mitochondrial stress markers (ATF4, ATF6, Grp78, Grp94) in the rat retinal tissue. This study indicates that oral supplementation of BCX exerts a protective effect on light-induced retinal damage in the rats via reducing oxidative stress and inflammation, also protected against mitochondrial DNA damage and cellular death.

The relationship between cognitive health and nutrition has long been an interesting as well as intriguing aspect of overall brain well-being. Many studies have demonstrated the role of nutrients in neuronal signaling pathways and synaptic plasticity. Moreover, brain being highly susceptible to oxidative stress, antioxidants in diet may play a pivotal role in preventing cognitive decay. Dietary components that inherently consist of neurotransmitters amply contribute to the improvement of cognitive functions. It is also well documented that diet patterns during early childhood abundantly influence cognitive performance in adulthood. Natural products are offered as nutritional supplements and seriously considered for improving agility and enhancing performance in active sports. This chapter reviews the correlation between nutrition and various brain functions and cognitive performance.

Retinal damage associated with loss of photoreceptors is a hallmark of eye diseases such as age-related macular degeneration (AMD) and diabetic retinopathy. Potent nutritional antioxidants were previously shown to abate the degenerative process in AMD. β-Cryptoxanthin (BCX) is an essential dietary carotenoid with antioxidant, anti-inflammatory, and provitamin A activity. It is a potential candidate for developing intervention strategies to delay the development/progression of AMD. In the current study, the effect of a novel, highly purified BCX oral formulation on the rat retinal damage model was evaluated. Rats were fed with BCX for four weeks at the doses of 2 and 4 mg/kg body weight in the form of highly bioavailable oil suspension, followed by retinal damage by exposing to the bright light-emitting diode (LED) light (750 lux) for 48 hrs. Animals were sacrificed after 48 hours, and eyes and blood samples were collected and analyzed. BCX supplementations (2 and 4 mg/kg) showed improvements in the visual condition as demonstrated by histopathology of the retina and measured parameters such as total retinal thickness and outer nuclear layer thickness. BCX supplementation helped reduce the burden of oxidative stress as seen by decreased serum and retinal tissue levels of malondialdehyde (MDA) and restored the antioxidant enzyme activities in BCX groups. Further, BCX supplementation modulated inflammatory markers (IL-1β, IL-6, and NF-κB), apoptotic proteins (Bax, Bcl-2, caspase 3), growth proteins and factors (GAP43, VEGF), glial and neuronal proteins (GFAP, NCAM), and heme oxygenase-1 (HO-1), along with the mitochondrial stress markers (ATF4, ATF6, Grp78, Grp94) in the rat retinal tissue. This study indicates that oral supplementation of BCX exerts a protective effect on light-induced retinal damage in the rats via reducing oxidative stress and inflammation, also protected against mitochondrial DNA damage and cellular death.

OBJECTIVES: Dry eye is a chronic condition associated with insufficient tear production and faster tear evaporation and commonly accompanied by inflammation that may lead to ocular surface damage. We have developed a multi-ingredient formulation containing lutein, zeaxanthin, curcumin, and vitamin D3 to address conditions associated with dry eye. The objective of this study was to evaluate the efficacy and safety of our formulation in subjects with mild to moderate dry eye symptoms. METHODS: This was a randomized, double-blind, parallel, placebo-controlled study. Sixty subjects with mild to moderate DES were randomly assigned in a 1 : 1 ratio to the test or placebo groups. Subjects consumed one capsule of the test or placebo product every morning through the study duration of 56 days. The test product comprised 20 mg lutein, 4 mg zeaxanthin, 200 mg curcuminoids, and 600 IU vitamin D3 in form of a capsule. The placebo product contained soybean oil. Changes in tear volume by Schirmer's test and severity of dry eye discomfort measured by Ocular Surface Disease Index (OSDI) score, changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break up time (TBUT), corneal & conjunctival staining, tear osmolarity, Matrix Metalloproteinases (MMP)-9 levels in tear fluid, and artificial tear usage were evaluated. RESULTS: Thirty subjects in Test and 29 in Placebo group completed study. We observed statistically significant (P

OBJECTIVES: Oral caffeine consumption results in rapid absorption with high blood levels followed by its sharp decline and is typically associated with reduction in beneficial effects of caffeine. To help extend the benefits of caffeine over a six-eight hour time period, we developed a new sustained release caffeine (SRC) formulation called Xtenergy(TM). The primary study objective was to compare the pharmacokinetic profile of SRC with immediate release caffeine (IRC). Secondary objectives were comparing the effects of SRC and IRC using caffeine research visual analogue scales (Caff - VAS) and evaluate its safety. METHODS: Twenty-six subjects were randomized to receive 200 mg of caffeine from SRC and IRC in a double blind, single-dose, two-period, crossover study in healthy subjects under fasting state. A washout duration of 7 days was followed between the two periods. Blood samples were collected at –4, 0, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 & 24 hours in each period. Plasma caffeine levels were analysed using a validated LCMS/MS method. The changes in Caff-VAS for relaxed, alert, jittery, tired, tense, headache & overall mood from baseline (0) to 1, 2, 4, 6, 8, 10 & 12 hrs were evaluated. RESULTS: Twenty-four male subjects with mean age 32.71 ± 6.18 yrs completed the study. Median t(max) was 325.53% higher (4.00 vs 0.94 hrs) and mean t(1/2) was 21.34% higher (9.24 ± 4.56 vs 7.61 ± 3.98 hrs) for SRC (P

Dry eye syndrome (DES) is a chronic condition of the eye with insufficient production of tears leading to inadequate lubrication of eyes. Symptoms of DES are associated with discomfort and redness of the eye, blurred vision, and tear film instability which leads to the damaged ocular surface. Inflammation and oxidative stress play a significant role in the pathogenesis of the disease. In this study, the protective effect of different doses (100 or 200 mg/kg) of a novel multi-component oral formulation of lutein/zeaxanthin, curcumin, and vitamin D3 (LCD) was evaluated using a rat model with benzalkonium chloride (BAC)-induced dry eye syndrome. The formulation was administered orally to rats for 4 weeks. We observed a significant improvement in tear volume, tear breakup time, tear film integrity, and reduction in overall inflammation in rats fed with the LCD at dose 200 mg/kg performing better than 100 mg/kg. Furthermore, the formulation helped in lowering oxidative stress by increasing antioxidant levels and restored protective tear protein levels including MUC1, MUC4, and MUC5AC with 200 mg of LCD having the most significant effect. The results strongly suggest that the combination of lutein/zeaxanthin, curcumin, and vitamin-D3 is effective in alleviating the symptoms of dry eye condition with a multi-modal mechanism of action.

OBJECTIVES: The retinal pigment epithelium (RPE) regulates the transport of nutrients and waste products to and from the retina and protects against light and oxidative stress. Structural or physiological dysfunction of RPE leads to retinal conditions such as age-related eye disease (ARED). It is well-established that artificial and natural light is an important factor in the progression of ARED as it can induce oxidative damage and photochemical lesions. Recently, the use of LED in general lighting has raised concerns regarding the effects of this light source on the RPE. The goal was to investigate whether beta-cryptoxanthin, an efficient pro-vitamin A carotenoid can exert protective effects against LED-induced RPE cell damage. METHODS: Rats were fed with BCX for 4 weeks at a dose of 2 and 4 mg/kg body weight followed by retinal damage by exposing the eye to bright LED light for 48 hrs. Commercially available white LED sources, which are widely used in rat housing studies was used to induce retinal damage. Animals were sacrificed at the end of the study and retinal tissue and blood samples were collected and evaluated for retinal damage and markers of oxidative stress. RESULTS: BCX supplementation significantly reduced retinal damage as demonstrated by histopathology measurements including total retinal thickness, outer nuclear layer thickness, and swelling. Similarly, markers of oxidative stress including serum and retinal tissue levels of malondialdehyde, superoxide dismutase, glutathione peroxidase, and catalase were beneficially modulated by BCX supplementation. In parallel, BCX supplementation reduced inflammatory markers (IL-1β, IL-6, NF-κB), angiogenic factor VEGF, apoptotic proteins (Caspase-3, GAP43, GFAP, NCAM, HO-1) and mitochondrial stress markers (ATF4, ATF6, Grp78, Grp97) in retinal tissue. CONCLUSIONS: Our study supports that oral supplementation of BCX dose-dependently exerts a protective effect against retinal damage induced by high-intensity light in a rat model by reducing oxidative stress, inflammation, angigogenesis and protection against mitochondrial DNA damage. BCX dietary intakes and supplementation throughout all stages of life can help protect against ARED that may start early in life. FUNDING SOURCES: OmniActive Health Technologies.

OBJECTIVES: Osteoarthritis (OA) of the knee is a chronic and painful debilitating disease. OA of the knee is initiated by physical damage and accumulated oxidative stress, followed by exaggerated inflammation leading to cartilage damage. Currently, no effective pharmacotherapy capable of restoring the cartilage tissue and joint architecture is available. Hence, there has been an attempt in developing alternative therapeutic approaches including herbal remedies. Curcumin from turmeric root used extensively in traditional medicine is a well-known anti-inflammatory agent. We have developed a novel, improved intestinal pH stable and highly bioavailable formulation of curcumin which is called Advanced Ultrasol Curcumin (AUC) and here we present data to demonstrate the efficacy of AUC in a rat model of knee OA. METHODS: Female Wistar rats were used to induce OA of the knee by intra-articular injection of sodium monoiodoacetate followed by recovery for 14 days. Seven rats were included in each group. Animals were supplemented with AUC for 4 weeks at two different concentrations (20 and 40 mg/kg of total curcuminoids) and assessment of disease was carried out by histopathology including integrity of joint architecture, and effect of supplementation on oxidative stress, inflammation and on extracellular matrix proteinases levels in joint tissue using western blot technique. RESULTS: We observed a significant restoration of joint architecture and reduction in swelling of joint as demonstrated by X-ray images and histopathology after 4 weeks of AUC administration. There was a significant reduction in serum and synovial tissue malondialdehyde levels and increased superoxide dismutase, glutathione peroxidase; and catalase levels. Further, there was a significant reduction in synovial inflammatory markers (IL-1β, IL-6, IL-10, TNF-α and CRP) and markers of cartilage damage such as COMP, collagen type 2 and MMP3 levels in synovial tissue. CONCLUSIONS: Curcumin is a well-established herbal ingredient for inflammatory diseases such as OA and AUC, a novel formulation of curcumin with enhanced intestinal stability and bioavailability is effective in ameliorating pathophysiology of OA in experimentally induced rat OA model in a dose dependent manner. FUNDING SOURCES: OmniActive Health Technologies Limited.

OBJECTIVES: Osteoarthritis (OA) is a debilitating chronic illness that affects millions across the globe. Current medical treatment approaches that focus on the reduction of pain and inflammation using pharmaceutical drugs are moderately effective and associated with significant adverse events. Hence health care professionals are exploring alternative approaches that are effective and safe to treat osteoarthritis. We developed a novel integrated active formulation to alleviate symptoms of osteoarthritis using improved plant extracts from Curcumin, Ashwagandha and Boswellia and validated the efficacy of the formulation using a well-established animal model for osteoarthritis. METHODS: We induced OA in female Wistar rats by intra-articular injection of sodium monoiodoacetate followed by recovery for 14 days. Seven rats were included in each group. Animals were supplemented with integrated active herbal formulation of enriched extracts of Curcumin, Boswellia and Ashwagandha for 4 weeks at two different concentrations (100 and 200 mg/kg body weight) and assessment of disease was carried out by histopathology including integrity of joint architecture, and effect of supplementation on oxidative stress, inflammation and on extracellular matrix proteinases levels in joint tissue using western blot technique. RESULTS: We observed a significant restoration of joint architecture and reduction in swelling of joint as demonstrated by X-ray images and histopathology after 4 weeks of administration integrated active herbal supplement. There was a significant reduction in serum and synovial tissue malondialdehyde levels and increased superoxide dismutase, glutathione peroxidase; and catalase levels. Synovial inflammatory markers (IL-1β, IL-6, IL-10, TNF-α and CRP) and markers of cartilage damage such as COMP, collagen type 2 and MMP-3 levels were significantly reduced in synovial tissue in response to supplementation. CONCLUSIONS: Our data indicate that our integrated active herbal formulation has a strong protective effect against OA in a dose dependent manner by acting through multi-modal pathways as substantiated by significant effects on histopathology, inflammation, oxidative stress and collagen degradation. FUNDING SOURCES: OmniActive Health Technologies Limited.

Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon? tablets (Sphaeranthus indicus based) in plaque psoriasis patients. Materials and Methods: Patients aged at least 18 years and older with clinical diagnosis of plaque psoriasis, were enrolled in this open label, non-comparative, multicenter trial. All eligible subjects received four 700 mg Tinefcon? tablets/day for 12 weeks. The primary outcome measure was percent change in Psoriasis Area Severity Index (PASI) score from baseline to week 12. The secondary outcome measures were Physician Global Assessment (PGA), Nail Psoriasis Severity Index (NAPSI), Psoriatic Arthritis Evaluation and Gene Expression Profiling and Immunohistochemistry. Results: After completion of Tinefcon? treatment at 12 weeks, more than half of subjects (52%) achieved PASI 50 response; PASI 75 response was attained in 68 (23%) subjects and PASI 90 response in 22 (7%) subjects. Five subjects with severe psoriasis achieved PASI 90 without receiving any concomitant medication. Reduction in severity as assessed by PGA was observed in more than half of patients with moderate disease. Histopathological evaluation revealed that epidermal thickness was considerably reduced in 66% of subjects. The expression of inflammatory marker S100A9 protein was(meaningfully reduced in 60% patients with non-significant reduction of Keratin 10 protein expression. Gene expression analysis showed increase down regulation of SERPINB4; PI3 and KRT16 genes after a 12-week treatment period in subjects with higher PASI scores. Conclusion: Oral Tinefcon? tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.