The Effects of Antioxidants and Pulsed Magnetic Fields on Slow and Fast Skeletal Muscle Atrophy Induced by Streptozotocin: A Preclinical Study.

Results: Our findings suggest that antioxidants and PMF may alleviate impaired protein synthesis and degradation pathways in skeletal muscle atrophy. PTS showed a positive effect on the anabolic pathway, while RSV and PMF demonstrated potential for ameliorating the catabolic pathway. Notably, the combination therapy of antioxidants and PMF exhibited a stronger ameliorative effect on skeletal muscle atrophy than either intervention alone. Conclusion: The present results highlight the benefits of employing a multimodal approach, involving both antioxidant and PMF therapy, for the management of muscle-wasting conditions. These treatments may have potential therapeutic implications for skeletal muscle atrophy.

A Standardized Withania somnifera (Linn.) Root Extract with Piperine Alleviates the Symptoms of Anxiety and Depression by Increasing Serotonin Levels: A Double-Blind, Randomized, Placebo-Controlled Study.

Background: Withania somnifera (Linn) or Ashwagandha is used in Ayurveda and other traditional medicine systems as an adaptogen and a neuroprotective supplement. Objective: The effect of Ashwagandha root extract (ARE) standardized for 2.5% full-spectrum withanolides as per The United States Pharmacopeia (USP) protocol with piperine (500 mg with 5 mg of 95% piperine) once a day (12.5 mg withanolides/day) was evaluated in individuals with mild to moderate depression and anxiety. Methods: In a randomized, double-blind placebo-controlled study, for 90 days, 70 participants were randomized to ARE (n = 34) or placebo (n = 36) once daily at night. Mean change in the Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS), Groningen Sleep Quality Scale (GSQS), and quality of life (QOL) from screening to days 30, 60, and 90 were evaluated. Safety was evaluated by monitoring any incidence of adverse events and laboratory parameters. Two-way analysis of variance (ANOVA) and repeated-measure ANOVA were used to compare ARE and placebo, and the changes within the group at different time points. Results: Seventy individuals were randomized and all of them completed the study. The HARS, HDRS, GSQS, and QOL scores improved significantly (p < 0.001) in all the participants taking ARE compared to placebo on days 30, 60, and 90. Anxiety and depression improved from baseline to end of the study in both groups, but the quantum of improvement was significantly higher in ARE. Serum levels of serotonin increased in ARE, but showed a decrease in placebo, the difference being statically significant (p < 0.001). Biochemical and hematological parameters remained in the normal range in all participants and ARE was well tolerated during the study. Conclusion: The results of the study suggest that 500 mg of ARE standardized for 2.5% withanolides with 5 mg piperine is beneficial in improving depression, and anxiety, by increasing serum serotonin levels. The trial was registered prospectively with the Clinical Trial Registry of India (CTRI) with the registration number CTRI/2022/05/042640, on May 18, 2022.

A standardized Ashwagandha root extract alleviates stress, anxiety, and improves quality of life in healthy adults by modulating stress hormones: Results from a randomized, double-blind, placebo-controlled study.

BACKGROUND: The coronavirus disease-2019 (COVID-19) pandemic has resulted in a surge in stress, anxiety, and depression worldwide. Ashwagandha, an ayurvedic adaptogen has been traditionally used to manage stress, anxiety, and general well-being. OBJECTIVE: We assessed the effect of Ashwagandha root extract (ARE-500 mg) standardized for 2.5% withanolides as per USP protocol with piperine (5 mg of 95% piperine) once daily for 60 days (12.5 mg withanolides/day) to alleviate stress and anxiety in healthy individuals with mild to moderate symptoms. METHODS: A randomized, double-blind, placebo-controlled study was conducted for 60 days using ARE (n = 27) and placebo (n = 27) once daily at night at Narayana Institute of Cardiac Sciences, Bangalore, and Vijaya Super Specialty Hospital, Nellore, in India. The objectives of this study were to assess an improvement in perceived stress scale (PSS), generalized anxiety disorder (GAD-7), quality of life (QOL), cognitive scores in the Cambridge Neuropsychological Test Automated Battery (CANTAB), changes in salivary cortisol, urinary serotonin, dopamine, serum levels of nitric oxide (NO), glutathione (GSH) and malondialdehyde (MDA) from baseline to end of the study. Safety was evaluated by laboratory parameters, and by monitoring any incidence of adverse events. RESULTS: 54 individuals were randomized and 50 of them completed the study. The PSS, GAD-7, and QOL scores improved significantly in all the participants taking ARE compared to the placebo. The CANTAB analysis revealed a significant improvement in multitasking, concentration, and decision taking time in ARE compared to placebo. ARE was also associated with a greater reduction in the morning salivary cortisol and an increase in urinary serotonin compared to placebo. Serum levels of NO, GSH, and MDA were not significantly different. Biochemical and hematological parameters remained in the normal range in all participants and ARE was well tolerated during the study. CONCLUSION: The results of the study suggest that ARE with 2.5% withanolides can effectively improve stress and anxiety by reducing cortisol and increasing serotonin in healthy individuals with mild to moderate symptoms.

A Short-Term Safety Evaluation of Silbinol®- an Extract from Pterocarpus marsupium in Healthy Adults- a Randomized, Double-Blind, Placebo-Controlled Study.

Background: Pterostilbene is an active molecule from the bark of the Pterocarpus marsupium tree with antioxidant and anti-inflammatory properties. Objective: This study aimed to evaluate the clinical safety of a standardized P. marsupium extract (PME) containing 90% pterostilbene (200 mg per day) in healthy adults. Methods: In a randomized, double-blind, placebo-controlled study, 60 healthy adult participants (27 males and 33 females) were randomized to receive PME-100 mg or placebo capsule twice a day for two months. The primary objectives of the study were to assess any changes in laboratory parameters, vital signs, and the occurrence of adverse events from screening to the final visit. Serum antioxidant enzyme levels were evaluated as a secondary outcome. Results: The hematological, lipid, glycemic, thyroid profiles and liver and renal functions remained within the normal range in all participants, with no difference between PME and placebo. Vital signs, including blood pressure, pulse rate, body weight, body mass index and electrocardiogram, did not reveal any significant differences between the PME and placebo groups at the beginning and end of the study. No serious adverse events were observed in any participant throughout the study period. The serum antioxidant profile was not significantly different between the treatment groups, although the glutathione levels were relatively higher in the PME group. Conclusions: Scientific evaluation of clinical safety of standardized extract is mandatory for its use as a supplement for various health benefits. The results of this study convincingly establish the safety of PME (>90% Pterostilbene) at 200 mg/day (100 mg bid) for human use. The study was approved by the Institutional Ethics Committee of BGS Global Institute of Medical Sciences & Hospital, Bangalore with the registration number CTRI/2019/08/020736.

Probiotic modulation of gut microbiota by Bacillus coagulans MTCC 5856 in healthy subjects: A randomized, double-blind, placebo-control study.

BACKGROUND: Probiotics are known to rebalance the gut microbiota in dysbiotic individuals, but their impact on the gut microbiome of healthy individuals is seldom studied. The current study is designed to assess the impact and safety of Bacillus coagulans (Weizmannia coagulans) microbial type culture collection 5856 (LactoSpore®) supplementation on microbiota composition in healthy Indian adults. METHODS: The study participants (N = 30) received either LactoSpore (2 billion colony-forming units/capsule) or placebo for 28 days. The general and digestive health were assessed through questionnaires and safety by monitoring adverse events. Taxonomic profiling of the fecal samples was carried out by 16S rRNA amplicon sequencing using the Illumina MiSeq platform. The bacterial persistence was enumerated by quantitative reverse transcription-polymerase chain reaction. RESULTS: Gut health, general health, and blood biochemical parameters remained normal in all the participants. No adverse events were reported during the study. Metataxonomic analysis revealed minimal changes to the gut microbiome of otherwise healthy subjects and balance of Bacteroidetes and Firmicutes was maintained by LactoSpore. The relative abundance of beneficial bacteria like Prevotella, Faecalibacterium, Blautia, Megasphaera, and Ruminococcus showed an increase in probiotic-supplemented individuals. The quantitative polymerase chain reaction analysis revealed highly variable numbers of B. coagulans in feces before and after the study. CONCLUSION: The present study results suggest that LactoSpore is safe for consumption and does not alter the gut microbiome of healthy individuals. Minor changes in a few bacterial species may have a beneficial outcome in healthy individuals. The results reiterate the safety of B. coagulans microbial type culture collection 5856 as a dietary supplement and provide a rationale to explore its effect on gut microbiome composition in individuals with dysbiosis.

A minor metabolite from Curcuma longa effective against metabolic syndrome: results from a randomized, double-blind, placebo-controlled clinical study.

Metabolic syndrome (MetS) is characterized by the presence of at least three interrelated risk factors, including central obesity, hypertension, elevated serum triglycerides, low serum high-density lipoproteins, and insulin resistance. Abdominal obesity is considered a predominant risk factor. Lifestyle changes with medications to lower cholesterol, blood sugar, and hypertension are the general treatment approaches. Functional foods and bioactive food ingredients represent versatile tools for addressing different aspects of MetS. In a randomized placebo-controlled clinical study, we evaluated the effect of Calebin A, a minor bioactive phytochemical from Curcuma longa, on metabolic syndrome in obese adults (N = 100), and 94 individuals completed the study (N = 47 in both groups). They were subjected to Calebin A supplementation for 90 days, which resulted in a statistically significant reduction in their body weight, waist circumference, body mass index, low-density lipoprotein-cholesterol, and triglyceride levels compared to those with the placebo. A small but significant increase in high-density lipoprotein-cholesterol levels was also observed in these individuals. Furthermore, Calebin A showed a positive effect on adipokines by reducing circulating leptin levels. Finally, C-reactive protein levels were significantly reduced in Calebin A-supplemented individuals, suggesting a beneficial impact on managing MetS-induced inflammation. Blood glucose levels, insulin resistance, and blood pressure levels were not affected by Calebin A. In conclusion, Calebin A may be an effective supplement for managing abdominal obesity, dyslipidemia, and systemic inflammation in individuals with metabolic syndrome. This study was prospectively registered on the Clinical Trial Registry of India (CTRI) with the registration number CTRI/2021/09/036495. https://ctri.nic.in/Clinicaltrials/advancesearchmain.php.

A Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Anti-Skin-Aging Effect of LactoSporin - The Extracellular Metabolite from Bacillus coagulans (Weizmannia coagulans) MTCC 5856 in Healthy Female Volunteers.

Purpose: There has been a growing interest in the use of probiotics and their products for skin care, over the last decade. LactoSporin is the extracellular metabolite of a spore-forming probiotic Bacillus coagulans (Weizmannia coagulans) MTCC 5856, with antimicrobial and skin protecting activity. Patients and Methods: The anti-skin-aging potential of LactoSporin was evaluated in a randomized, double-blinded, placebo-controlled study in healthy female participants (70 screened and 56 randomized). The participants applied either LactoSporin or matched placebo formulation (N=28 in each group) for 10 weeks, and the effects were assessed by dermatological, and non-invasive instrument-based evaluation using Antera, Cutometer, Corneometer, and Tewameter. All the 56 participants completed the study and were included for the analysis. Results: The regular use of LactoSporin cream for 10 weeks showed a significant reduction in visibility of wrinkles around crow's feet, nasolabial folds, frown lines, and facial fine lines compared to baseline and placebo by dermatological and Antera assessments. LactoSporin showed improvement in skin elasticity and hydration by dermatological assessments, but the effect was not significantly different from placebo when assessed by Cutometer, Corneometer, and Tewameter. No adverse events or skin irritation was observed in any participants during the study. Conclusion: These results suggest that LactoSporin could be a safe natural ingredient to reduce wrinkles and fine lines in cosmetic formulations.

The effects of Bacillus coagulans MTCC 5856 on functional gas and bloating in adults: A randomized, double-blind, placebo-controlled study.

BACKGROUND: Gut microbiome dysbiosis is a major cause of abdominal gas, bloating, and distension. Bacillus coagulans MTCC 5856 (LactoSpore) is a spore-forming, thermostable, lactic acid-producing probiotic that has numerous health benefits. We evaluated the effect of Lacto Spore on improving the clinical symptoms of functional gas and bloating in healthy adults. METHODS: Multicenter, randomized, double-blind, placebo-controlled study at hospitals in southern India. Seventy adults with functional gas and bloating with a gastrointestinal symptom rating scale (GSRS) indigestion score ≥ 5 were randomized to receive B coagulans MTCC 5856 (2 billion spores/day, N = 35) or placebo (N = 35) for 4 weeks. Changes in the GSRS-Indigestion subscale score for gas and bloating and global evaluation of patient's scores from screening to the final visit were the primary outcomes. The secondary outcomes were Bristol stool analysis, brain fog questionnaire, changes in other GSRS subscales, and safety. RESULTS: Two participants from each group withdrew from the study and 66 participants (n = 33 in each group) completed the study. The GSRS indigestion scores changed significantly (P < .001) in the probiotic group (8.91-3.06; P < .001) compared to the placebo (9.42-8.43; P = .11). The median global evaluation of patient's scores was significantly better (P < .001) in the probiotic group (3.0-9.0) than in the placebo group (3.0-4.0) at the end of the study. The cumulative GSRS score, excluding the indigestion subscale, decreased from 27.82 to 4.42% (P < .001) in the probiotic group and 29.12 to 19.33% (P < .001) in the placebo group. The Bristol stool type improved to normal in both the groups. No adverse events or significant changes were observed in clinical parameters throughout the trial period. CONCLUSIONS: Bacillus coagulans MTCC 5856 may be a potential supplement to reduce gastrointestinal symptoms in adults with abdominal gas and distension.

Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea-a randomized, double-blind, placebo-controlled study.

Objectives: Acute diarrhea in children is generally managed by replacing the lost fluid with oral rehydration solution (ORS). Probiotic supplementation has been reported to reduce the severity of diarrhea. In the present study, we investigated the effect of Weizmannia coagulans (Bacillus coagulans) MTCC 5856, along with ORS on acute diarrhea of all causes in non-hospitalized children. Methods: A total of 110 children of ages between 1 and 10 were enrolled in a double-blind placebo-controlled study and were randomly allocated to receive W. coagulans MTCC 5856 (4 × 108 spores, N = 54) + ORS and zinc (Zn) or a placebo (N = 56) + ORS and (Zn) for 5 days. The consistency of the stool, mean duration of diarrhea in hours, mean diarrhea frequency per day, and the dehydration status were collected as efficacy endpoints. Safety was evaluated by the occurrence of adverse events. Results: The mean age of the children was 5.55 ± 2.57 years (61 boys and 49 girls). The mean duration of diarrhea was 51.31 ± 20.99 h in the W. coagulans MTCC 5856 group and 62.74 ± 24.51 h in the placebo (p = 0.011) group. The frequency of diarrhea was lower in children supplemented with the probiotic, but the difference was not statistically significant. The perceived efficacy score and dehydration status improved significantly in the W. coagulans MTCC 5856 group compared with the placebo group. No adverse events were recorded. Conclusion: The results of the study suggest that W. coagulans MTCC 5856 could be supplemented along with ORS and zinc to reduce the duration of diarrhea in non-hospitalized children. Clinical Trial Registration: ClinicalTrials.gov, identifier CTRI/2022/06/043239.

A scientifically validated combination of garcinol, curcuminoids, and piperine for mild to moderate nonalcoholic steatohepatitis patients-results from a randomized, double-blind, placebo-controlled study.

Background: Garcinol is a naturally occurring compound from the fruit rind of the Garcinia indica, with antioxidant, anti-inflammatory, and anticancer properties. Curcuminoids are the active molecule from the rhizome of Curcuma longa, studied extensively for its health benefits as an anti-inflammatory and antioxidant activities. Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic steatohepatitis characterized by liver fat and inflammation. Objective: To evaluate the clinical efficacy and safety of Garcinol, Curcuminoids and piperine (GCP) combination in patients with mild to moderate NASH in a randomized, double-blind, placebo-controlled study. Methods: The patients received one tablet (450 mg) of GCP containing garcinol-50 mg, curcuminoids -250 mg and piperine 5 mg or a placebo (450 mg of microcrystalline cellulose) twice daily for 90 days. Changes in circulating aspartate aminotransferase (AST), alanine transaminase (ALT) levels, liver stiffness measurement (LSM), and controlled attenuation parameter (CAP) using Fibroscan were compared from baseline to day 90. Anthropometric parameters, serum levels of lipids, Interleukin (IL-6), hsCRP, and adiponectin were estimated. Safety was evaluated by laboratory parameters and by monitoring adverse events. Results: Seventy-two patients were randomized and 63 (GCP = 32, Placebo = 31) completed the study. The mean age of the patients was 48.3 ± 8.7 years (36 males and 27 females). The mean reduction in AST (U/L) was 9.53 in GCP and 3.16 in placebo (p < 0.001) and that of ALT (U/L) was 13.47 in GCP and 7.43 in Placebo (p = 0.002). The liver stiffness and CAP scores showed a better reduction in GCP (0.56 kPa and 12.38 db/m) compared to placebo (0.064 kPa and 10.42 db/m) p < 0.05. Consequently, the noninvasive Fibroscan-AST (FAST) score reduction was also found to be significant in GCP compared to placebo. Additionally, body weight, lipid levels, hsCRP, and IL-6 in serum decreased, while adiponectin levels increased in GCP-supplemented participants compared to placebo. The combination of garcinol and curcuminoids was well tolerated with no significant changes in hematological and clinical laboratory parameters during the 90-day supplementation. Conclusion: Our results suggest that GCP could be a possible supplement for the management of NASH.Clinical trial registration: https://clinicaltrials.gov/, identifier CTRI/2019/11/022147.

Novel Emblica officinalis extract containing ß-glucogallin vs. metformin: a randomized, open-label, comparative efficacy study in newly diagnosed type 2 diabetes mellitus patients with dyslipidemia.

The efficacy of Emblica officinalis extract (EOE) containing 10% ß-glucogallin was compared against metformin in newly diagnosed subjects with diabetic dyslipidemia which is a significant factor in cardiovascular disease. Daily administration with EOE-1 g, EOE-2 g, or metformin 500 mg for 90 days significantly decreased fasting blood sugar and postprandial blood sugar (FBS and PPBS), hemoglobin A1c (HbA1c) and lipid levels in all three treatment groups. The FBS, PPBS and HbA1c were significantly lower in the EOE-2 g group compared with metformin and EOE-1 g groups. The reductions in LDL and TC in the EOE-2 g group were also significantly higher than in the EOE-1 g group and were comparable to the metformin group. No serious adverse effects were observed in any study participants. EOE-1 g and 2 g day-1 are safe and potent antidiabetic agents, with comparable efficacy to the pharmaceutical drug, metformin. Supplementation with EOE-2 g day-1 showed greater efficacy than metformin in reducing circulating glucose levels.

Pharmacology of α-spinasterol, a phytosterol with nutraceutical values: A review.

α-Spinasterol is a phytosterol found in various edible and non-edible plant sources. The edible plant materials containing α-spinasterol include spinach leaves, cucumber fruits, seeds of pumpkin and watermelon, argan seed oil, cactus pear seed oil and Amaranthus sp. It is a bioavailable nutraceutical, and it can cross the blood-brain barrier. It possesses several important pharmacological properties such as anti-diabetes mellitus, antiinflammation, hypolipidemic, antiulcer, neuroprotection, anti-pain and antitumour activities. For this review, literature search was made focusing on the pharmacological properties of α-spinasterol using PubMed and Google Scholar data bases. Recent studies show the promising antidiabetic properties of α-spinasterol. Its anti-diabetic mechanisms include enhancement of insulin secretion, reduction in insulin resistance, anti-diabetic nephropathy, increase in glucose uptake in muscle cells and inhibition of glucose absorption from intestine. Besides, it is a safe antiinflammatory agent, and its antiinflammatory mechanisms include inhibition of cyclooxygenases, antagonism of TRPV1 receptor and attenuation of proinflammatory cytokines and mediators. It is a promising and safe nutraceutical molecule for human health care. Food supplements, value-added products and nutraceutical formulations can be developed with α-spinasterol for the management of diabetes, chronic inflammatory diseases and improving general health. This review provides all scattered pharmacological studies on α-spinasterol in one place and highlights its immense value for human health care.

Can Selenium Reduce the Susceptibility and Severity of SARS-CoV-2?-A Comprehensive Review.

The SARS-CoV-2 infection is a highly contagious viral infection, which has claimed millions of lives in the last two years. The infection can cause acute respiratory distress, myocarditis, and systemic inflammatory response in severe cases. The interaction of the viral spike protein with the angiotensin-converting enzyme in various tissues causes damage to vital organs and tissues, leading to complications in the post-infection period. Vaccines and antiviral drugs have improved patient response to the infection, but the long-term effect on vital organs is still unknown. Investigations are now focused on supportive nutrient therapies, which can mitigate the susceptibility as well as the long-term complications of COVID-19. Selenium is one such micronutrient that plays a vital role in preventing oxidative stress induced by the virus. Further, selenium is important for effective immune response, controlling systemic inflammation, and maintain overall health of humans. We examine the role of selenium in various aspects of SARS-CoV-2 infection and address the importance of selenium supplementation in reducing the susceptibility and severity of infection in this review.

The Anti-Obesity Potential of Cyperus rotundus Extract Containing Piceatannol, Scirpusin A and Scirpusin B from Rhizomes: Preclinical and Clinical Evaluations.

PURPOSE: Obesity is a complex medical problem that increases the risk of other diseases like diabetes, cardiovascular diseases, and fatty liver disease. The present study evaluated the efficacy and safety of Cyperus rotundus rhizome extract (CRE), standardized to contain Piceatannol, Scirpusin A, and Scirpusin B (5% total Stilbenoids) in overweight individuals. The mechanism of activity was evaluated in a diet-induced mice model of obesity and adipocytes in vitro. MATERIALS AND METHODS: The efficacy, safety, and tolerability of CRE were evaluated in 30 obese individuals with a BMI of 30 to 40 kg/m2 for 90 days in a randomized, double-blind, parallel-group, placebo-controlled study. In vitro studies were carried out in differentiated 3T3 L1 adipocytes, and the therapeutic efficacy was evaluated in high-fat diet-induced obese mice. RESULTS: The pilot clinical study showed a reduction in body weight with a significant decrease in waist circumference and BMI. The serum lipid profile showed a significant improvement in CRE-treated individuals. The extract was well tolerated, and no adverse effects were reported at the end of the study. CRE showed a dose-dependent adipogenesis reduction in vitro with an IC50 value of 9.39 µg/mL, while oral administration of CRE reduced weight gain in diet-induced obese mice. The efficacy in mice was associated with reduced levels of leptin, corticosteroids, and serum lipid levels, with no adverse effects. CONCLUSION: CRE has anti-adipogenic properties, is safe for human consumption, and effectively manages weight and hypercholesterolemia in overweight individuals.

A randomized, double-blind clinical trial of a herbal formulation (GlycaCare-II) for the management of type 2 diabetes in comparison with metformin.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major public health concern with growing prevalence with multiple debilitating complications. GlycaCare-II is a proprietary herbal formulation supplement for T2DM containing extracts of Cinnamomum cassia, Momordica charantia, Pterocarpus marsupium, Gymnema sylvestre, Salacia reticulata, Eugenia jambolana, and a bioavailability enhancer piperine from Piper nigrum. OBJECTIVE: The antihyperglycemic potential of GlycaCare-II was compared against metformin in a double-blind study. DESIGN: It was a randomized, two-arm design on prediabetic (N = 29; 12 in metformin and 17 in GlycaCare-II arm, respectively) and newly diagnosed diabetic (N = 40; 16 in metformin and 24 in GlycaCare-II) patients for 120 days. OUTCOME MEASURES: Changes in diabetic panel glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and postprandial blood sugar (PBS) were the primary endpoints. Lipid profile, liver profile, thyroid-stimulating hormone, bilirubin and creatinine were the secondary endpoints. RESULT: Twice a day treatment for 120 days with GlycaCare-II led to a statistically significant change in HbA1c (p < 0.001), FBS (p < 0.001), PBS (p < 0.001) on both prediabetic and newly diagnosed diabetic patients. GlycaCare-II showed a similar potential as metformin in the treatment of T2DM. In the prediabetic group, both GlycaCare-II and metformin were comparable for all the hyperglycemic index parameters. In the case of newly diagnosed diabetic patients, GlycaCare-II showed a significantly better reduction for PBS (p = 0.026) as compared to metformin, while all other parameters in the diabetic panel were comparable. No adverse events were reported throughout the trial period. CONCLUSION: These results suggest that GlycaCare-II is effective in managing T2DM in both newly diagnosed diabetic and prediabetic patients.

Boswellia serrata Extract Containing 30% 3-Acetyl-11-Keto-Boswellic Acid Attenuates Inflammatory Mediators and Preserves Extracellular Matrix in Collagen-Induced Arthritis.

Boswellia serrata extracts have been traditionally employed for the treatment of inflammatory diseases. In the present study, we have evaluated the mechanism of activity of Boswellin Super® FJ (BSE), a standardized extract of B. serrata containing not less than 30% 3-acetyl-11-keto-ß-boswellic acid along with other ß-boswellic acids. The in vitro anti-inflammatory activities were carried out in RAW 264.7 macrophages or human peripheral blood mononuclear cells stimulated with bacterial lipopolysaccharides (LPS) and treated with 1.25-5µg/ml BSE. The anti-arthritic activity of the extract was evaluated in a rat model of collagen-induced arthritis. BSE at 40 and 80mg/kg and celecoxib 10mg/kg were orally dosed for 21days. BSE showed significant (p<0.05) inhibition of inflammation (TNF-α, IL-6, nitric oxide, and COX-2 secretion) and downregulates the mRNA levels of TNF-α, IL-6, IL1-ß, and inducible nitric oxide synthase in macrophages. BSE treatment reduced the levels of phosphorylated-NF-κB (P65), suggesting an anti-inflammatory activity mediated by blocking this key signal transduction pathway. In addition, BSE showed inhibition (p<0.05) of collagenase, elastase, hyaluronidase enzymes, and a reduction in reactive oxygen species and matrix-degrading proteins in RAW 264.7 macrophages stimulated with LPS. BSE treatment significantly (p<0.05) reduced the arthritic index, paw volume, and joint inflammation comparable to celecoxib in collagen-induced arthritis (CIA) in rats. The circulating anti-collagen antibodies were reduced in BSE and celecoxib-treated animals as compared to the CIA. In confirmation with in vitro data, BSE showed a significant (p<0.05) dose-dependent effect on C-reactive protein, prostaglandin E2, and erythrocyte sedimentation rate, which is widely used as a blood marker of inflammation. Further, BSE treatment suppressed the cartilage oligomeric matrix protein and significantly enhanced the hyaluronan levels in synovial fluid. As observed by collagen staining in joints, the loss of matrix proteins was lower in BSE-treated animals, suggesting that BSE could preserve the extracellular matrix in RA. The extract showed inhibition of collagenase enzyme activity in vitro, further strengthening this hypothesis. BSE treatment was found to be safe, and rats displayed no abnormal behavior or activities. The results suggest that Boswellin Super® mediates its activity by preserving matrix proteins, reducing pro-inflammatory mediators, and oxidative stress.

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActiveTM) for COVID-19 Patients.

BACKGROUND: SARS-CoV-2 has emerged as a global threat due to its infectivity and rapid transmission. We evaluated the safety and efficacy of herbal and mineral formulation (ImmuActive) as an adjunct therapy in COVID-19 patients. METHODS: A randomized, double-blind, placebo-controlled study was conducted in 100 COVID-19 patients in three centers in Southern India, and 92 subjects completed the study. Subjects were followed up until they were discharged from the hospital or for a maximum of 28 days, whichever was earlier. The primary outcome parameters were the mean change and time required to change the ordinal scale of disease severity by one unit. The secondary outcomes were the time required to turn RT-PCR negative or get discharged from the hospital, change in modified Jackson's Symptom Severity score, and COVID-19 quality of life questionnaire. RESULTS: The ordinal scale at the end of the study was significantly lower in COVID-19 patients supplemented with ImmuActive (0.57) than placebo (1.0), with a p value of 0.0043. The ordinal scale decreased by one unit within 2.35 days in ImmuActive-supplemented patients, while it took 3.36 days in placebo-supplemented patients. Days of hospitalization and time required to turn RT-PCR negative were comparatively lower in the ImmuActive arm than the placebo arm. Change in modified Jackson's Symptom Severity Score and COVID-19 QOL were significant from screening to the end of the study in both ImmuActive and placebo arms. There were no adverse events observed during the study period. CONCLUSION: The study results suggest that ImmuActive could be a beneficial and safe adjunct treatment for effectively managing COVID-19 infection symptoms.

Lesser Investigated Natural Ingredients for the Management of Obesity.

Obesity, an epidemiological disorder, is related to various complications in both the developed and developing world. It epitomizes a crucial risk factor for health, decreasing productivity and life expectancy while increasing health care costs worldwide. Conventional therapies with synthetic drugs or bariatric surgery, associated with numerous side effects, recurrence, and surgical complexity, have been restricted in their use. Lifestyle changes and dietary restrictions are the proven methods for successful weight loss, although maintaining a strict lifestyle is a challenge. Multiple natural products have been explored for weight management with varied efficacy. The current review explores less explored natural herbs, their active constituents, and their mechanisms of action against obesity.

An exploratory study of selenium status in healthy individuals and in patients with COVID-19 in a south Indian population: The case for adequate selenium status.

The acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has affected millions of individuals, causing major health and economic disruptions worldwide. The pandemic is still raging, with a second and third wave in a few countries, while new infections steadily rise in India. Nutrition and immune status are two critical aspects of fighting the virus successfully. Recently, selenium status was reported to positively correlate with the survival of patients with COVID-19 compared with non-survivors. We analyzed the blood serum levels in 30 apparently healthy individuals and in 30 patients with confirmed COVID-19 infection in the southern part of India. The patients showed significantly lower selenium levels of 69.2 ± 8.7 ng/mL than controls 79.1 ± 10.9 ng/mL. The difference was statistically significant (P = 0.0003). Interestingly, the control group showed a borderline level of selenium, suggesting that the level of this micronutrient is not optimum in the population studied. The results of this exploratory study pave the way for further research in a larger population and suggest that selenium supplementation may be helpful in reducing the effects of the virus.

Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Product in Healthy Adult Male and Female Volunteers with Hair Fall.

BACKGROUND: Hair fall is a widespread problem among all genders, ages, and ethnicity with both physical and psychological effects. OBJECTIVE: This clinical study was designed to evaluate the efficacy and safety of a hair serum formulation containing amla extract, freeze-dried coconut water, and the micronutrient selenium along with sandalwood odorant and peanut shell extract in healthy male and female volunteers with hair fall. METHODS: A total of 42 subjects were enrolled and completed the study and they used the test product daily for 90 days. TrichoScan® was used to evaluate the efficacy of the test product for improving hair growth rate, hair density, anagen hair, telogen hair, and the density of vellus and terminal hair. Hair thinning and hair fall reduction were compared to its basline by both dermatologists and subject self-assessment questionnaires. RESULT AND DISCUSSION: After 90 days of test product application, there was a significant improvement in hair growth rate (<0.0001), hair density (<0.0001), vellus hair density (<0.0001), and terminal hair density (<0.0001) in comparison to baseline. There was a significant reduction in hair fall with bulb (<0.0001) and without bulb (<0.0001), and hair thinning (<0.0001) compared to the baseline measurement. Adverse events were not recorded during the study. No skin intolerance was reported during the study, and the test product was considered dermatologically safe to use.