Corrigendum: A natural sustained-intestinal release formulation of red chili pepper extracted capsaicinoids (Capsifen®) safely modulates energy balance and endurance performance: a randomized, double-blind, placebo-controlled study.

[This corrects the article DOI: 10.3389/fnut.2024.1348328.].

A natural sustained-intestinal release formulation of red chili pepper extracted capsaicinoids (Capsifen®) safely modulates energy balance and endurance performance: a randomized, double-blind, placebo-controlled study.

Introduction: Overweight and obesity are major public health concerns, with a sharp increase in prevalence over the last few decades. The primary cause is an imbalance between calorie intake and expenditure due to a rise in calorie-rich processed food and reduced physical activity. Energy balance in humans involves complex processes including thermogenesis, a crucial factor in regulating energy expenditure. Methods: In this randomized, double-blinded, placebo-controlled three-arm three-sequence study, we investigated the efficacy of Capsifen® (CapF), a pungency-masked sustained-intestinal release formulation of red chili extract, on energy expenditure, fat oxidation, and endurance using the Quark C-PET system in healthy overweight participants, with and without exercise. In the study, 105 healthy participants were randomized to receive either placebo, CapF 100 mg/day, or CapF 200 mg/day for 28 days. Results: CapF demonstrated a dose-dependent response to increased energy expenditure and fatty acid oxidation with a concomitant reduction in body weight. Both CapF 100 and CapF 200 also increased the time to exhaustion. Discussion: These results demonstrate the plausible efficacy of CapF in energy expenditure and physical performance in otherwise healthy adults who have a high body mass index. Clinical trial registration: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjQzNTg=&Enc=&userName=CTRI/2018/04/013157 dated 04 October 2018.

Corrigendum: Exploring the short-term influence of a proprietary oil extract of black cumin (Nigella sativa) on non-restorative sleep: a randomized, double-blinded, placebo-controlled actigraphy study.

[This corrects the article DOI: 10.3389/fnut.2023.1200118.].

Review: bioavailability and efficacy of 'free' curcuminoids from curcumagalactomannoside (CGM) curcumin formulation.

The golden spice turmeric with its main bioactive component curcumin is one of the most popular and extensively studied nutraceuticals. Despite numerous pre-clinical studies reporting positive pharmacodynamics of turmeric extracts and curcumin, the main issues in translating the pharmacological effects to clinical efficacy have been to overcome its poor pharmacokinetics and to deliver significant amounts of the biologically relevant forms of the actives to various tissues. This review is aimed at providing a first critical evaluation of the current published literature with the novel curcumagalactomannoside (CGM) formulation of curcumin using fenugreek galactomannan dietary fibre, specifically designed to address curcumin poor pharmacokinetics. We describe CGM and its technology as a food-grade formulation to deliver 'free' unconjugated curcuminoids with enhanced bioavailability and improved pharmacokinetic properties. The therapeutic relevance of improving bioavailability of 'free' curcuminoids and some of the technical challenges in the measurement of the 'free' form of curcuminoids in plasma and tissues are also discussed. A total of twenty-six manuscripts are reviewed here, including fourteen pre-clinical and twelve clinical studies that have investigated CGM pharmacokinetics, safety and efficacy in various animal models and human conditions. Overall current scientific evidence suggests CGM formulation has improved bioavailability and tissue distribution of the biologically relevant unconjugated forms of turmeric actives called 'free' curcuminoids that may be responsible for the superior clinical outcomes reported with CGM treatments in comparison with unformulated standard curcumin across multiple studies.

Coconut sugar derived from coconut inflorescence sap lowers systolic blood pressure and arterial stiffness in middle-aged and older adults: a pilot study.

Nutraceutical-based interventions hold promise to reduce blood pressure (BP) and arterial stiffness, which are two cardiovascular disease (CVD) risk factors. However, the effects of coconut sap powder (CSP), an Asian sweetener and novel nutraceutical, on BP and arterial stiffness in middle-aged and older adults (MA/O, ≥45 yr) has yet to be established. We hypothesized CSP will decrease BP and arterial stiffness in MA/O adults. In a double-blind, randomized, placebo-controlled study design, 19 (age 55.3 ± 2.1 yr) MA/O adults completed measures of brachial and carotid BP, and arterial stiffness [carotid-femoral pulse wave velocity (cfPWV), common carotid artery (CCA) ß-stiffness, compliance, distensibility, and Young's and Peterson's Elastic moduli] before and after 8 wk of CSP (1.5 g/day) or placebo (1.5 g/day). A two-way repeated-measures analysis of variance was used to compare group mean differences. Compared with placebo, CSP lowered brachial systolic BP (SBP) (CSP pre: 117.4 ± 2.9 vs. post: 109.0 ± 2.4 mmHg, P < 0.05), but not carotid SBP (P = 0.12). CSP also lowered Young's (CSP pre: 5,514.4 ± 1,115.4 vs. post: 3,690.6 ± 430.9 kPa) and Peterson's elastic moduli (CSP pre: 22.2 ± 4.4 vs. post: 19.2 ± 4.5 kPa) (P < 0.05, both). A trend for CSP to lower CCA ß-stiffness (P = 0.06) and increase CCA compliance (P = 0.07) was also observed. Arterial stiffness assessed by cfPWV did not change (P > 0.05). No inflammatory or antioxidant biomarkers were affected by CSP. In summary, 8 wk of CSP lowers brachial SBP and CCA mechanical stiffness indicating a potential cardioprotective effect in MA/O adults.NEW & NOTEWORTHY Blood pressure (BP) and arterial stiffness are important predictors of cardiovascular health with aging. Nutraceuticals are an easy-to-implement lifestyle strategy demonstrating promise to effectively lower BP and arterial stiffness with aging and ultimately cardiovascular disease risk. We demonstrate that coconut sap powder (CSP), a traditional Asian sweetener, lowers brachial systolic BP and carotid artery mechanical stiffness in middle-aged and older (MA/O) adults. These findings provide initial evidence for the CSP-related cardioprotective effects in MA/O adults.

Exploring the short-term influence of a proprietary oil extract of black cumin (Nigella sativa) on non-restorative sleep: a randomized, double-blinded, placebo-controlled actigraphy study.

Background: Nigella sativa (black cumin, or black seed) is popularly known as the seed of blessings in the Arab system of medicine. Though not widely recommended for sleep, a unique proprietary black cumin extract (BlaQmax®/ThymoDream™; BCO-5) has been shown to be helpful in the management of stress and sleep issues. Methods: This randomized, double-blind, placebo-controlled trial aimed to investigate the efficacy of BCO-5 on the sleep quality of volunteers characterized with a self-reported non-restorative sleep disorder. Healthy male and female participants (n = 70), aged 18-65 years (BMI 22-28 Kg/m2) were randomized to either placebo or BCO-5 (n = 35/group). Both interventions were supplemented at 200 mg/day for seven days. Actigraphy and a validated restorative sleep questionnaire (RSQ-W) were used to monitor the influence of BCO-5 on sleep. Results: Compared to placebo, BCO-5 significantly improved sleep quality, as evidenced by both intra-group and inter-group analyses of the actigraphy data. The relative improvements observed were sleep efficiency (7.8%, p < 0.001), total sleep time (19.1%, p < 0.001), sleep onset latency (35.4%; p < 0.001), and wake-after-sleep-onset (22.5%; p < 0.001) compared with placebo. BCO-5 also improved sleep by 75.3% compared to baseline (p < 0.001) and by 68.9% compared to placebo (p < 0.001), when monitored by RSQ-W. BCO-5 was well-tolerated with no reports of side effects or toxicity. Conclusion: BCO-5 significantly improved non-restorative sleep in seven days, indicating its potential role as a natural sleep aid.

The effects of oral administration of curcumin-galactomannan complex on brain waves are consistent with brain penetration: a randomized, double-blinded, placebo-controlled pilot study.

OVERVIEW: A novel highly bioavailable curcumin-galactomannan (CGM) formulation was shown to have improved blood-brain-barrier (BBB) permeability of free curcuminoids in animal models; however, this has not been established in humans. The present study was conducted to determine the functional effects of CGM on brain waves in healthy individuals, owing to its BBB permeability. METHODS: A total of 18 healthy volunteers aged 35-65 were randomly assigned to consume 500 mg CGM, Unformulated curcumin (UC) or Placebo capsules twice daily for 30 days. Electroencephalogram (EEG) measurements, audio-visual reaction time tests and a working memory test were conducted at baseline and after 30 days. RESULTS: Supplementation of CGM resulted in a significant increase in α- and ß-waves (p < 0.05) as well as a significant reduction in α/ß ratio in comparison with unformulated curcumin and placebo groups. Furthermore, the CGM showed significant reduction in the audio-reaction time (29.8 %; p < 0.05) in comparison with placebo and 24.6% (p < 0.05) with unformulated curcumin. The choice-based visual-reaction time was also significantly decreased (36%) in CGM as compared to unformulated curcumin and placebo which produced 15.36% and 5.2% respectively. CONCLUSION: The observed increase in α and ß waves and reduction in α/ß ratio in the CGM group suggest that CGM can influence the brain waves in healthy subjects in a manner consistent with penetration of the blood-brain-barrier. The EEG results correlated with improved audio-visual and working memory tests which further support the role of CGM on memory improvements and fatigue reduction.

Brain regional pharmacokinetics following the oral administration of curcumagalactomannosides and its relation to cognitive function.

OBJECTIVE: Though a number of bioavailable formulations of curcuminoids have been reported and available commercially as nutraceuticals for brain health, systematic informations on their blood-brain-barrier permeability and brain tissue distribution have not been reported. The present study was aimed to investigate the brain regional pharmacokinetics of curcuminoids following both single dose and repeated dose oral administration of a self-emulsifying food-grade formulation of curcuminoids using fenugreek galactomannan hydrogel scaffold as 'curcumagalactomannosides' (CGM), and its influence on cognitive functions in comparison with unformulated natural curcuminoids (NC) in Wistar rats. METHODS: CGM was given to animals in single dose (100 mg curcuminoids/kg b. wt.) and repeated dose (100 mg curcuminoids/kg b. wt. for 28 days) and the concentration of total curcuminoids at various parts of brain was evaluated at different time points using Ultra-performance liquid chromatography/electrospray ionization triple quadruple tandem mass spectroscopy (UPLC-ESI-MS/MS) system. Another set of animals were also fed with CGM at single dose (100 mg curcuminoids/kg b. wt.) and repeated dose (100 mg curcuminoids/kg b. wt. for 28 days) and the behavioural studies were conducted using open field test and radial arm maze. RESULTS: UPLC-ESI-MS/MS analyses of plasma revealed significant absorption of unconjugated (free) curcuminoids upon both single and repeated dose administration of CGM with maximum concentrations of 173.34 ± 27.12 ng/mL and 223.22 ± 32.73 ng/mL, respectively. Further analysis of brain tissues demonstrated significant blood-brain-barrier permeability. Brain regional pharmacokinetics (AUC, Cmax and t1/2) indicated a relative distribution order of hippocampus > striatum > cerebellum > cerebral cortex > brain stem. Supplementation of CGM for 28 days also offered significant (p < 0.05) improvement in locomotor activity and reduction in spatial memory errors as compared to NC. The NC treatment also improved the behaviour better than the vehicle-treated group. CONCLUSION: CGM could distribute significant amount of free curcuminoids, in brain especially in the hippocampus at both single and repeated dose administration with an elimination half-life of 2.6 h. CGM also showed a positive impact in behaviour of animals in comparison with normal unformulated curcuminoids.

Natural self-emulsifying reversible hybrid-hydrogel delivery (N'SERH) of tocopherol enhances bioavailability and modulates alcohol-induced reproductive toxicity in rats.

Alpha-tocopherol (α-Toc), an antioxidant vitamin, has been widely prescribing in the treatment of infertility, in spite of its limited oral bioavailability. The present study describes the enhanced bioavailability and efficacy of a novel 'natural self-emulsifying reversible hydrogel' (N'SERH)-based oral delivery form of α-Toc-rich sunflower oil (Tα-fen) using fenugreek galactomannan hydrogel scaffold (hybrid-FENUMATTM ). Tα-fen was characterised by FTIR, SEM, TEM and DLS as a hybrid-hydrogel powder. The bioavailability study on thirty (n = 30) male Sprague Dawley rats randomised into two groups indicated 4.84-fold increase in the oral bioavailability when the formulation was provided at 15 mg/kg b. wt. of α-Toc by oral gavage. The efficacy study on 24 animals randomised into four groups as control, ethanol treated (4 mg/kg b. wt.), ethanol+unformulated, UTα (15 mg/kg b. wt.) and ethanol+formulation, Tα-fen (15 mg/kg b. wt.) revealed significant improvement (*p < 0.05) and reversal of alcohol-induced reproductive toxicity as evident from the enhanced sperm count, motility and viability parameters, testosterone levels, fructose content, and SDH activity and plasma antioxidant status among Tα-fen-treated rats, compared with unformulated, UTα-treated group. Histopathology further confirmed the reversal of the alterations in the testes morphology of Tα-fen-treated animals, indicating its promising potential in the treatment of reproductive health issues.

Anti-Ulcerative Effect of Curcumin-Galactomannoside Complex on Acetic Acid-Induced Experimental Model by Inhibiting Inflammation and Oxidative Stress.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that affects the mucosa and submucosa of colon. The pathogenesis of ulcerative colitis (UC) is related to reduced antioxidant capacity and increased inflammatory processes. Reactive oxygen metabolites are the potent inflammatory mediators that may be involved in tissue injury in inflammatory bowel disease. Conventional drug therapies for UC come with a myriad of side effects which further raise the need for natural bioactive agents. Curcumin has proven to be beneficial in the prevention and treatment of a number of inflammatory diseases, but due its poor bioavailability, the therapeutic applications are limited. Thus, to enhance its bioavailability, a new formulation - curcumin-galactomannoside (CGM)- was made by complexing curcumin with galactomannans derived from fenugreek. The present study aims to evaluate the effects of CGM on experimental UC model. Adult male Wistar rats were divided into 5 groups: normal control rats (NC); ulcerative colitis control rats (UC); UC + sulfasalazine (SS) treated; UC + curcumin (CM) treated; and UC + CGM supplemented for 21 days. The colonic mucosal injury was assessed by macroscopic and histological examination, along with evaluation of antioxidant status, inflammatory mediators, and gene expressions. Administration of CGM significantly enhanced antioxidant activities and decreased the level of inflammatory mediators and also suppressed the expression of inflammatory markers as compared with other groups. In conclusion, findings from these results reveal that CGM exerts marked curative effects on acute experimental colitis, possibly by regulating the antioxidant status and modulating inflammatory cascade.

Water-soluble polyphenol-rich clove extract lowers pre- and post-prandial blood glucose levels in healthy and prediabetic volunteers: an open label pilot study.

BACKGROUND/OBJECTIVES: Type 2 diabetes (T2D) is a global pandemic, and contributes significantly to the increasing incidence of conditions such as cardiovascular disease (CVD). Postprandial plasma glucose measured 2-h after the start of a meal is a good indicator of the overall status of glucose homeostasis. Clove (Syzygium aromaticum L.) and its essential oils (eugenol and acetyl eugenol) have been shown in preclinical studies to modulate pathways involved in glucose homeostasis. In addition, a water-soluble polyphenolic extract of unopened clove buds was recently shown to benefit liver function and redox status. Therefore, we conducted an open-label pilot study to test whether this polyphenolic clove extract (PCE) could influence glucose metabolism. METHODS: We evaluated the effect of PCE supplementation (250 mg once daily for 30 days) on preprandial glucose levels and 2-h postprandial glucose levels in 13 otherwise healthy volunteers who were stratified into two groups according to their initial preprandial glucose levels: Group I (n = 7) ≤100 mg/dL, Group II (n = 6) - between 101 and 125 mg/dL. In an effort to elucidate the molecular mechanisms of PCE action, we tested in vitro the effects of PCE on glucose uptake, hepatocyte glucose production, and carbohydrate hydrolyzing enzymes. RESULTS: At day 12 of supplementation, we observed statistically significant reductions in mean postprandial glucose levels in both groups [(Group I: Initial - Day 12 PPG = 13.29 mg/dL, 95% CI: 3.329-23.24) (Group II: Initial - Day 12 PPG = 16.67 mg/dL, 95% CI: 4.687-28.65, P = 0.0159)], which continued through study completion at day 30. PCE supplementation significantly decreased mean preprandial glucose levels only in Group II at Days 24 (Initial - Day 24 = 13.00 mg/dL, 95% CI: 1.407-24.59, P = 0.0345) and 30 (Initial - Day 30 = 13.67 mg/dL, 95% CI: 5.766-21.57, P = 0.0067). In cell-based assays, PCE enhanced glucose uptake in L6 myocytes and inhibited hepatocyte glucose production HepG2 cells. In cell-free assays, PCE inhibited α-amylase activity and α-glucosidase activity. CONCLUSIONS: These findings underscore the therapeutic utility of PCE for maintaining healthy glucose metabolism and warrant further larger-scale clinical trials. TRIAL REGISTRATION: This trial was retrospectively registered in the ISRCTN registry on September 29, 2018 ( ISRCTN15680985 ).

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

[This corrects the article DOI: 10.1155/2018/9159281.].

Toxicological evaluation of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®): Acute, sub-chronic and genotoxicity studies.

The present study investigated the safety of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®; FHE), that has been clinically shown to be effective in ameliorating the postmenopausal discomforts and establishing hormonal balance. The safety was assessed by oral acute (2500 mg/kg b. wt. for 14 days) and subchronic (250, 500 and 1000 mg/kg b. wt. for 90 days) toxicity studies on Wistar rats and mutagenicity studies employing Salmonella typhimurium strains. Administration of FHE did not produce any toxicologically significant changes in clinical/behavioral observations, ophthalmic examinations, body weight, organ weight, feed consumption, urinalysis, hematology and clinical biochemistry parameters when compared to the untreated control group of animals. Highest dose recovery group (1000 mg/kg b. wt.) of animals also showed no mortality or adverse events; with hematological and biochemical parameters at par with those of controls. Terminal autopsy revealed no alterations in relative organ weight or any treatment-related histopathology changes. FHE also showed no mutagenicity upon Ames test employing TA-98, TA-100 and TA-102 Salmonella typhimurium strains with or without metabolic activation. Based on the results of the study, the no observed-adverse-effect level (NOAEL) of FHE was determined as 1000 mg/kg b. wt./day, the highest dose tested.

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

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.

Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study.

Despite the availability of various synthetic drugs for the treatment of functional dyspepsia (FD), the side effects and their cost have always created a great interest in the search for novel natural alternatives for the management of gut disorders. The present contribution reports the safety and efficacy of the kitchen spice asafoetida (Ferula asafoetida) in FD for the first time. In the double-blinded, placebo-controlled study, 43 subjects diagnosed to have moderate to severe discomforts of nonulcer FD were randomized to receive hard-shell capsules (250 mg × 2/day) of either placebo (n=22) or a food-grade formulation of asafoetida (Asafin) (n=21) for 30 days. When evaluated by a set of validated indexing tools (GSRS, GDSS, and NDI), almost 81% in the Asafin group showed significant (p < 0.01) improvement in the overall score and quality of life as compared to the placebo. At the end of the study, 66% of subjects in the Asafin group remained symptoms-free. Although the symptoms score improved significantly in both the groups (from -5.67 to -25.29 in Asafin group versus -1.55 to -6.0 in the placebo; p ≤ 0.001), the relative percentage of subjects in the Asafin group with more than 80% reduction in various symptoms were: bloating (58%), appetite (69%), postprandial fullness (74%) motion sickness (75%), and digestion (77%) as compared to less than 10% nonspecific improvement in the placebo group. All the subjects remained safe with no adverse events or variations in haematological and biochemical parameters. The study was registered at http://ctri.nic.in/ (CTRI/2018/ 01/011149).

Curcumin-galactomannoside complex inhibits pathogenesis in Ox-LDL-challenged human peripheral blood mononuclear cells.

Oxidised low-density lipoprotein (ox-LDL) is a pro-atherogenic molecule, which induces inflammatory response and contributes to the pathogenesis of vascular dysfunction to atherosclerosis. The aim of the present study was to explore the anti-inflammatory effect of a novel bioavailable formulation of curcumin as 'curcumagalactomannosides' (CGM) against ox-LDL-induced inflammatory responses in human peripheral blood mononuclear cells (hPBMCs). Curcumagalactomannosides was made from natural curcumin using the soluble dietary fibre (galactomannans) derived from fenugreek seeds (Trigonella foenumgracum) and the hPBMCs were isolated from healthy human volunteers. The cells were cultured in collagen-coated plates at 37 °C and grouped as Group I (Control), Group II (ox-LDL treated) and Group III (ox-LDL + CGM treated). Further analysis of inflammatory markers, reactive oxygen species and mRNA expression levels indicated significantly increased expressions of iNOS, TNF-α, IL-6 and VCAM-1 in ox-LDL-treated group along with the nuclear translocation of NF-κB. Other inflammatory markers such as LOX, PGE2, total COX and lipid peroxidation level were also found to be significantly (p < 0.05) increased upon ox-LDL treatment. The treatment with CGM on the other hand was found to down-regulate and reverse the ox-LDL-induced alterations indicating its potential anti-inflammatory effect on hPBMCs via. NF-κB signalling pathway.

Optimization of antioxidant efficacy of a deflavored and decolorized rosemary extract: effect of carnosol content on the oxidative stability of paprika colored beef patties.

Considering the significance of natural antioxidants to preserve meat, the present study was undertaken to evaluate the efficacy of a deflavored and decolorised extract of rosemary (StabilRose™) for the production and preservation of naturally colored fresh meat. Oxidative rancidity of meat and color degradation of paprika oleoresin were exploited as model systems and compared with butylated hydroxyanisole (BHA). The results showed similar efficacy for 3% carnosic acid extract and BHA, with further enhancement in efficacy with respect to the carnosic acid content. A synergetic antioxidant effect of carnosol on carnosic acid content was also noticed to an extent of 1:1 (w/w) ratio, and further increase in carnosol content showed no improvement in the antioxidant efficacy. Finally, stabilized paprika and optimized rosemary extract containing carnosic acid and carnosol in 1:1 (w/w) ratio was successfully applied to produce naturally colored meat suitable for storage at 4 ± 1 °C.

Anti-inflammatory effect of a novel formulation of coconut inflorescence sap against ox-LDL induced inflammatory responses in human peripheral blood mononuclear cells by modulating TLR-NF-κB signaling pathway.

Oxidized low density lipoprotein (ox LDL) induced inflammatory response was reported to play an important role in the pathogenesis of atherosclerosis. The purpose of this study was to explore the anti-inflammatory effect of a novel formulation of coconut inflorescence sap (CSP); COCOZEN™ against ox-LDL induced inflammatory responses in human peripheral blood mononuclear cells (hPBMCs). The hPBMCs were isolated from healthy human volunteers and cultured in collagen coated plates at 37 °C. The cells were grouped as Group I (Control), Group II (ox-LDL treated) and Group III (ox-LDL + CSP treated). Further analysis of inflammatory markers, reactive oxygen species, mRNA and protein expression levels indicated increased expressions of TLR-4, TNF-α, IL-6 and VCAM-1 in ox-LDL treated group along with the nuclear translocation of NF-κB. Other inflammatory markers such as LOX, PGE2, NO, total COX and lipid peroxidation level were also found to be significantly (p < .05) increased upon Ox-LDL treatment. The treatment with CSP on the other hand was found to down regulate and reverse the ox-LDL-induced alterations indicating its potential anti-inflammatory effect on hPBMCs via TLR-NF-κB signaling pathway.

A Novel Extract of Fenugreek Husk (FenuSMART™) Alleviates Postmenopausal Symptoms and Helps to Establish the Hormonal Balance: A Randomized, Double-Blind, Placebo-Controlled Study.

Despite the widespread use of hormone replacement therapy, various reports on its side effects have generated an increasing interest in the development of safe natural agents for the management of postmenopausal discomforts. The present randomized, double-blinded, placebo-controlled study investigated the effect of 90-day supplementation of a standardized extract of fenugreek (Trigonella foenum-graecum) (FenuSMART™), at a dose of 1000 mg/day, on plasma estrogens and postmenopausal discomforts. Eighty-eight women having moderate to severe postmenopausal discomforts and poor quality of life (as evidenced from the scores of Greene Climacteric Scale, short form SF-36® and structured medical interview) were randomized either to extract-treated (n = 44) or placebo (n = 44) groups. There was a significant (p < 0.01) increase in plasma estradiol (120%) and improvements on various postmenopausal discomforts and quality of life of the participants in the extract-treated group, as compared with the baseline and placebo. While 32% of the subjects in the extract group reported no hot flashes after supplementation, the others had a reduction to one to two times per day from the baseline stages of three to five times a day. Further analysis of haematological and biochemical parameters revealed the safety of the extract and its plausible role in the management of lipid profile among menopausal women. Copyright © 2016 John Wiley & Sons, Ltd.

Safety and anti-ulcerogenic activity of a novel polyphenol-rich extract of clove buds (Syzygium aromaticum L).

Despite the various reports on the pharmacology of Clove bud [Syzygium aromaticum]-derived essential oil and its major component eugenol, systematic information on the bioactivity of clove polyphenols is very limited. Clove buds being one of the richest sources of dietary polyphenols with many traditional medicinal uses, the present contribution attempted to derive their standardized polyphenol-rich extracts as a water soluble free flowing powder (Clovinol) suitable for functional food applications, without the issues of its characteristic pungency and aroma. The extract was characterized by electrospray ionization-time of flight mass spectrometry (ESI-TOF-MS), and investigated for in vivo antioxidant, anti-inflammatory and anti-ulcerogenic activities. Clovinol showed significant antioxidant and anti-inflammatory effects as measured by cellular antioxidant levels, and the ability to inhibit carrageenan-induced paw swelling in mice. Further investigations revealed its significant anti-ulcerogenic activity (>97% inhibition of ethanol-induced stomach ulcers in Wistar rats when orally administered at 100 mg per kg b.w.) and up regulation of in vivo antioxidants such as superoxide dismutase (SOD), glutathione (GSH), and catalase (CAT). Clovinol also reduced the extent of lipid peroxidation among ulcer induced rats, indicating its usefulness in ameliorating oxidative stress and improving gastrointestinal health, especially upon chronic alcohol consumption. The extract was also shown to be safe and suitable for further investigations and development upon acute toxicity studies at 5 g per kg body weight and 28 days of repeated dose toxicity studies at 2.5 g per kg b.w.