Two-month period of 500 mg lecithin-based delivery form of quercetin daily dietary supplementation counterbalances chronic fatigue symptoms: A double-blind placebo controlled clinical trial.

BACKGROUND: Chronic fatigue (CF) is a complex phenomenon without clear etiology that may require long-term treatment, but to date, no specific therapy has been identified for it. Some botanicals might be helpful in the management of CF. Among these botanicals, quercetin demonstrates its capacity to modulate multiple biological pathways and acknowledged major properties in CF: antioxidant, anti-inflammatory, immunomodulating, improving exercise endurance, enhancing mitochondrial biogenesis, repairing mitochondrial dysfunction. PURPOSE: Given this background, the aim of this study was to evaluate if a 2-month period of daily Quercetin Phytosome™ 500 mg supplementation is of benefit for the relief of CF. METHODS: The primary end point has been the evaluation of fatigue, by Fatigue Impact Scale (FIS-40). The secondary end points have been the assessment of sleep, by Pittsburgh Sleep Quality Index (PSQI), evaluation of muscle performance, by short physical performance battery and by wearable armband-shaped sensor in order to evaluate the number of steps, body composition, by DXA and quality of life by Short-Form 12-Item Health Survey (SF-12). RESULTS: Seventy-eight subjects (42 F; 36 M) (mean age 56 ± 9) reporting CF symptoms, completed the study (placebo/supplement 38/40). The FIS-40 mean difference changes between groups (supplement minus placebo) was - 10.583 points (CI95% -11.985; -9.182) (p < 0.001). Also, statistically significant changes between groups have been recorded in Pittsburgh Sleep Quality Index - 2.040 points (CI95%: -2.770; -1.309), p < 0.01), number of steps 1443.152 (CI95%: 1199.556; 1686.749), and SPPB (score) 0.248 (CI95%: 0.105; 0.391) (p < 0.001). CONCLUSION: The quercetin supplementation counterbalances CF symptoms.

Phytoextracts for Human Health from Raw and Roasted Hazelnuts and from Hazelnut Skin and Oil: A Narrative Review.

The objectives of this narrative review are as follows: an evaluation of the bromatological composition of hazelnuts and a comparison of the nutritional properties of raw versus roasted hazelnuts, taking into account potential differences among varieties from different production territories such as Turkey, Italy, Chile, and New Zealand; an evaluation of nutrients contained in hazelnut skin; and an evaluation of nutrients contained in hazelnut oil. This review incorporates 27 scientific articles that measured and reported the concentrations of macro- and micro-nutrients in hazelnuts. These hazelnuts were subjected to different processing methods, originated from various geographical areas, or belonged to different varieties. Our results showed that the different varieties and territories where the hazelnuts were cultivated influence their bromatological composition, and we found that different processing steps can largely influence the concentration of specific nutrients. The removal of the skin, which contains a very high concentration of compounds with antioxidant action, is particularly critical. We should give greater attention to the skin, considering it not as a waste product, but as an important part of the hazelnut due to its nutritional properties of primary relevance in the Mediterranean diet. We provide a detailed assessment of the nutritional properties of the hazelnut kernel, skin, and oil, evaluating nutrient compositions and possible modifications (increases or reductions) that occur during the roasting process or that depend on the production territory and origin.

Diet and ideal food pyramid to prevent or support the treatment of diabetic retinopathy, age-related macular degeneration, and cataracts.

Many eye diseases, such as diabetic retinopathy (DR), age-related macular degeneration (AMD), and cataracts are preventable and treatable with lifestyle. The objective of this review is to assess the most recent research on the ideal dietary approach to prevent or support the treatment of DR, AMD, and cataracts, as well as to construct a food pyramid that makes it simple for people who are at risk of developing these pathologies to decide what to eat. The food pyramid presented here proposes what should be consumed every day: 3 portions of low glycemic index (GI) grains (for fiber and zinc content), 5 portions (each portion: ≥200 g/day) of fruits and vegetables (spinach, broccoli, zucchini cooked, green leafy vegetables, orange, kiwi, grapefruit for folic acid, vitamin C, and lutein/zeaxanthin content, at least ≥42 µg/day, are to be preferred), extra virgin olive (EVO) oil (almost 20 mg/day for vitamin E and polyphenols content), nuts or oil seeds (20-30 g/day, for zinc content, at least ≥15.8 mg/day); weekly: fish (4 portions, for omega-3 content and eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) 0.35-1.4 g/day), white meat (3 portions for vitamin B12 content), legumes (2 portions for vegetal proteins), eggs (2 portions for lutein/zeaxanthin content), light cheeses (2 portions for vitamin B6 content), and almost 3-4 times/week microgreen and spices (saffron and curcumin). At the top of the pyramid, there are two pennants: one green, which indicates the need for personalized supplementation (if daily requirements cannot be met through diet, omega-3, and L-methylfolate supplementation), and one red, which indicates that certain foods are prohibited (salt and sugar). Finally, 3-4 times per week, 30-40 min of aerobic and resistance exercises are required.

CoQ10Phytosomes Improve Cellular Ubiquinone Uptake in Skeletal Muscle Cells: An Ex Vivo Study Using CoQ10-Enriched Low-Density Lipoproteins Obtained in a Randomized Crossover Study.

Coenzyme Q10 (CoQ10) bioavailability in vivo is limited due to its lipophilic nature. Moreover, a large body of evidence in the literature shows that muscle CoQ10 uptake is limited. In order to address cell specific differences in CoQ uptake, we compared cellular CoQ10 content in cultured human dermal fibroblasts and murine skeletal muscle cells that were incubated with lipoproteins from healthy volunteers and enriched with different formulations of CoQ10 following oral supplementation. Using a crossover design, eight volunteers were randomized to supplement 100 mg/daily CoQ10 for two weeks, delivered both in phytosome form (UBQ) as a lecithin formulation and in CoQ10 crystalline form. After supplementation, plasma was collected for CoQ10 determination. In the same samples, low density lipoproteins (LDL) were extracted and normalized for CoQ10 content, and 0.5 µg/mL in the medium were incubated with the two cell lines for 24 h. The results show that while both formulations were substantially equivalent in terms of plasma bioavailability in vivo, UBQ-enriched lipoproteins showed a higher bioavailability compared with crystalline CoQ10-enriched ones both in human dermal fibroblasts (+103%) and in murine skeletal myoblasts (+48%). Our data suggest that phytosome carriers might provide a specific advantage in delivering CoQ10 to skin and muscle tissues.

Vitamin D from UV-Irradiated Mushrooms as a Way for Vitamin D Supplementation: A Systematic Review on Classic and Nonclassic Effects in Human and Animal Models.

Recent literature has shown that vitamin D, in addition to its well-known activity on the skeleton, has many positive effects on health. Unfortunately, it is not easy to meet intake needs solely with food. Mushrooms could provide a valid way to achieve this goal, because they are one of the few sources of vitamin D. The aim of this systematic review was to summarize what has been reported in the literature on the treatment of animal and human models with irradiated commercial mushrooms, with particular attention paid to the effects on clinical outcomes associated with the classical and nonclassical vitamin D functions. A total of 18 articles were selected. Six studies were conducted on human samples, while twelve were focused on animal models. The six studies conducted in humans involved a large number of subjects (663), but the treatment period was relatively short (1-6 months). Furthermore, the treatment dosage was different in the various groups (600-3800 IU/day). Probably for this reason, the studies did not demonstrate clinical efficacy on the parameters evaluated (cognitive functions, muscle system/function, metabolic syndrome). Indeed, those studies demonstrated an efficacy in increasing the blood levels of 25(OH)D2, but not in increasing the levels of 25(OH)D total. In 9 of 12 studies conducted on the animal model, however, a clinical efficacy on bone metabolism, inflammation, and cognitive performance was demonstrated. The results of this systematic review indicate that the intake of vitamin D from irradiated mushrooms could possibly help to meet vitamin D needs, but the dosage and the time of treatment tested need to be evaluated. Therefore, studies conducted in humans for longer periods than the studies carried out up to now are necessary, with defined dosages, in order to also evaluate the clinical efficacy demonstrated in animal models both for the classical (bone metabolism) and nonclassical (muscle function, cognitive performance, anti-inflammatory, and antioxidant activities) effects of vitamin D.

A meta-analysis on the changes of BMI during an inpatient treatment with different follow-up lengths (short and long term) compared with the outpatient phase in obese patients.

BACKGROUND: The management of obesity should be multidimensional based on the choice of the treatment and the intensity of the therapeutic-rehabilitative intervention. This meta-analysis aims to compare the changes on body weight and body mass index (BMI) during an inpatient treatment (hospitalized weight loss programs with different durations in terms of weeks) compared with the outpatient phase. METHODS: The data obtained from the studies on inpatients have been layered into two categories: short term (studies with follow-up of max 6 months) and long term (studies with follow-up up to 24 months). Furthermore, this study evaluates which of the two approaches show the best impact on weight loss and BMI during 2 follow-ups at 6 to 24 months. RESULTS: The analysis, which included seven studies (977 patients), revealed that the subjects underwent a short hospitalization had greater benefit, compared to those who were followed for a long time. The meta-analyzed mean differences for random effect (MD) showed a statistically significant decrease on BMI of -1.42 kg/m2 (95% CI: -2.48 to -0.35; P = 0.009) and on body weight -6.94 (95% CI: -10.71 to -3.17; P = 0.0003) for subjects who carry out a short hospitalization compared to outpatients. No reduction of body weight (p = 0.07) and BMI (p = 0.9) for subjects who undergo a long hospitalization compared to an outpatient. CONCLUSIONS: A short-term inpatients multidisciplinary weight loss program could be the best choice for the management of obesity and its related comorbidities; on the contrary, if the follow-up is of long duration, the significance is not confirmed. The hospitalization at the beginning of any obesity treatment is significantly better than only outpatients treatment.

Discovering the Physio-Pathological Mechanisms of Interaction between Bone Mineral Density, Muscle Mass, and Visceral Adipose Tissue in Female Older Adults through Structural Equation Modeling.

This study aims to examine the relation between visceral adipose tissue (VAT), as a proxy for metabolically unhealthy obesity, muscle, as a proxy for muscle quality and sarcopenia, and bone, as a proxy for bone mineral density and osteoporosis. Other variables, such metabolic syndrome, nutritional status, number of diseases, kidney and liver function and inflammation were assessed as direct or indirect effects. This study used structural equation modeling (SEM) in a sample of 713 older women (mean age 82.1 ± 6.3). The results indicate a positive statistically significant association between bone and muscle mass (ß = 0.195, <0.001) and nutritional status and muscle mass (ß = 0.139, p < 0.001), but negative association between age with muscle mass (ß = -0.509, p < 0.001) and nutritional status (estimates: -2.264, p < 0.001). A negative association between VAT and muscle mass was also reported (ß = -1.88, p < 0.001). A negative statistically significant association was reported between bone mineral density and functional status (ß = -1.081, p < 0.001), and a positive association between functional status and muscle mass (ß = 9.000, p < 0.001). In addition, functional status was positively statistically associated with cognitive performance (ß = 0.032, p < 0.001). The SEM method demonstrates that the VAT, muscle mass and bone mineral density are associated, but the form of the relation is different in relation to different factors, such as nutritional status, mental and functional status, age, and number of pathologies, having different impacts on metabolic outcomes. SEM is a feasible technique for understanding the complex mechanisms of frailty in the elderly.

Anthocran® Phytosome®: Prevention of Recurring Urinary Infections and Symptoms after Catheterization.

In this preliminary pilot registry study, we investigated the effects of the oral supplementation of a standardized cranberry extract (Anthocran® Phytosome®, Indena) delivered by a lecithin-based system, for the prophylactic management of recurrent-urinary tract infections (R-UTIs). We included 64 otherwise healthy subjects who underwent a surgical procedure and required post-surgical urinary catheterization for high-risk UTIs or a previous history of R-UTIs. Patients were given supplementation with the standardized cranberry extract at the dose of either 120 mg/day (n = 12) or 240 mg/day (n = 12) or assigned to a control group consisting of standard management (SM; n = 18) or nitrofurantoin administration (n = 22) for 4 weeks. After 4 weeks, patients receiving the standardized cranberry supplementation reported to have a more effective reduction in UTI symptoms, as assessed on the visual analogue scale, compared with patients in the SM or nitrofurantoin groups. The occurrence of hematuria and urine bacterial contamination were decreased among patients treated with the supplement compared with controls (p < 0.05). The cranberry extract was also superior to the control management in terms of recurrence of signs/symptoms, with none of the patients in this group suffering from a R-UTI in the 3 months following the study end (p < 0.05). The supplementation showed an optimal safety profile, with no significant adverse events and no drop-outs in the supplement group. This registry shows that this cranberry extract is effective as a supplementary, preventive management in preventing post-operative, post-catheter UTIs; the product has a good tolerability profile.

A 60-Day Green Tea Extract Supplementation Counteracts the Dysfunction of Adipose Tissue in Overweight Post-Menopausal and Class I Obese Women.

Menopause is characterized by weight gain and increased visceral fat, which acts as an endocrine organ secreting proinflammatory adipocytokines, with consequent increased risk of metabolic disorders. The aim of this double-blind, placebo-controlled randomized trial was to evaluate the effects of a 60-day dietary supplementation using Camellia sinensis leaf extract on adipose tissue dysfunction in overweight or class I obese post-menopausal, sedentary women. Primary endpoints were the respiratory quotient (RQ), the percentage of carbohydrates (%CHO), the percentage of fat oxidation (%FAT), and the resting energy expenditure (REE) measured by indirect calorimetry. Secondary endpoints included body composition, by dual x-ray absorptiometry (DXA), glucose profile, lipid profile, inflammatory state, liver and kidney function, hormonal status regarding satiety, and status of catecholamines. Twenty-eight women were randomized into two groups: 14 (BMI 31.1 ± 3.5) were supplemented and 14 (BMI 31.9 ± 2.2) received placebo. In regards to the between-group differences over time (ß), a statistically significant difference between the supplemented and placebo group was observed for: RQ (ß = -0.04, p = 0.009), % fat oxidation (ß = 11.04, p = 0.0006), insulin (ß = -1.74, p = 0.009), HOMA (ß = -0.31, p = 0.02), waist circumference (ß = -1.07, p = 0.007), REE (ß = 83.21, p = 0.009), and CRP (ß = -0.14, p = 0.02). These results demonstrate that a 60-day green tea extract supplementation counteracts the dysfunction of adipose tissue in overweight post-menopausal and class I obese women.

Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM).

BACKGROUND: In patients affected by head and neck squamous cell carcinoma, the onset of severe oral mucositis is a decisive factor in completing concurrent chemo-radiotherapy, and few interventions have demonstrated a modest benefit. The primary aim of this clinical study was to evaluate the role of SAMITAL in reducing the incidence of severe mucositis induced by concurrent chemo-radiotherapy; the secondary aims were the tolerability and patient-reported quality of life measures. METHODS: Patients were randomized to receive SAMITAL granules for oral suspension of 20 mL, four-time daily or matching placebo in a 1:1 fashion using a stratified-block randomization scheme by disease site and type of chemotherapy. The SAMITAL/placebo was dispensed at the baseline visit and at each weekly visit following radiotherapy initiation. Patients were subjected to weekly endoscopic evaluations to assess the presence of mucositis. In addition, patient-reported outcomes were measured. RESULTS: Among the 116 patients treated with a median total dose of 66 Gy, 59 were randomized to SAMITAL and 57 to placebo. Overall, the incidence of severe mucositis was 51.7%, with 45.8% in the SAMITAL and 57.9% in the placebo arm (OR = 0.6; 95% CI: 0.3-1.3). After chemo-radiotherapy, patients randomized to SAMITAL reported significantly lower xerostomia, coughing and swallowing scores and a better quality of life. CONCLUSION: SAMITAL did not significantly reduce the incidence of severe mucositis in all studied populations. However, the lower rate of mucositis, together with a significantly better quality of life, suggested that a clinical benefit existed. This trial is registered with the EU Clinical Trials Register database, number 2012-002046-20, and with ClinicalTrials.gov, NCT01941992.

Bone Mineral Density Reference Values in 18- to 95-Year-Old Population in Lombardy Region, Italy.

The aim of this study is to assess the bone mineral density (BMD) and T-score reference values in a population from 18 to 95 years old in Lombardy region, Italy. This study also investigates the association between BMD values and body mass index (BMI) divided by gender and age. The evaluation of BMD was analyzed by T-score and BMD in each site, femur, and column. A total of 10,503 patients (9,627 females and 876 males, 65.04±12.18 years) have been enrolled in this study. The women hip femur reference values associated with a situation of osteopenia highlighted in-line with the class of age of 45 to 55 years were: mean values: -1.3132 T-score; 95% confidence interval (CI): -1.3600 to -1.2664 and of osteoporosis from the class of age 85 to 95 years, mean values: -2.6591 T-score, 95% CI: -2.7703 to -2.5479. The men hip femur reference values associated with a situation of osteopenia highlighted in-line with the class of age of 45 to 55 years were: mean values: 1.2986 T-score; 95% CI: -1.5454 to -1.0518. A positive association between BMI and the two sites of BMD was recorded (p > .05). This study provides an Italian overview of national and regional reference values about the BMD and T-score values divided by age and gender as reference values for clinicians for a correct assessment and monitoring.

Promising Health Benefits of Adjuvant Acmella and Zingiber Extracts Combined with Coenzyme Q10 Phytosomes, Supplementation in Chronic Pain Treated with Medical Cannabis: A Prospective and Open-Label Clinical Study.

Background: Chronic pain is a condition where pain persists for months or even years. Nowadays, several drugs comprising of medical cannabis are utilized for chronic pain relief. Even if there are some associated side effects, the use of supplements can widen the reliable tools available for improving an individual's quality of life. Objective: The aim of the present study was to evaluate the efficacy in terms of pain intensity, psychological well-being, and quality of life of a new dietary supplement in chronic pain subjects under current treatment with medical cannabis. Methods: In this pilot study, 48 medical cannabis-treated subjects were supplemented with a dietary supplement containing a combination of standardized Zingiber officinalis and Acmella oleracea extracts in phytosome (Mitidol), coenzyme Q10 phytosome (Ubiqsome), and group B vitamins (B1, B6, and B12), twice daily for 90 days. In order to explore the benefits of the product as an adjuvant supplementation for pain relief, the pain intensity, measured by the visual analogue scale (VAS), the pain type, and quality, evaluated by the Italian Pain Questionnaire (QUID) and the possible reduction of therapeutic and/or painkiller doses were recorded. Results: After 90 days, significant pain relief was detected in almost 70% of the subjects receiving the new dietary supplement, with sensory, emotional, and pain amelioration in one-third of them. A reduction in both tetrahydrocannabinol (THC) and cannabidiol (CBD) doses was also observed after 3 months of supplementation. These findings demonstrate new perspectives for the use of an innovative dietary supplement that combines Acmella and Zingiber extracts, Coenzyme Q10, and group B vitamins resulting in a beneficial long-term adjuvant in cannabis-treated pain subjects.

Multidisciplinary residential program for the treatment of obesity: how body composition assessed by DXA and blood chemistry parameters change during hospitalization and which variations in body composition occur from discharge up to 1-year follow-up.

PURPOSE: Obesity is a chronic disease characterized by a complex variable clinical presentation with comorbidities. A multidisciplinary residential program (MRP) represents one of the best options for treating obesity. The purpose of this study was to evaluate the effectiveness of 8-week MRP on weight loss, body composition assessed by DXA, and metabolic blood parameters between entry (T0) and discharge (T1). The secondary endpoint was the evaluation of the patients' adherence to diet during the check-up outpatient visits, at 2 (T2), 6 (T3), and 12 (T4) months after discharge. METHODS: 168 subjects were enrolled (61 males and 117 females, aged 58.5 ± 13 years, BMI 41.3 ± 6 kg/m2) in the study. The difference in values ​​(end of hospitalization compared to baseline) was calculated through the univariate analysis procedure, which provides regression analysis and analysis of variance for a variable dependent on one or more variables. RESULTS: There was a statistically significant improvement of all parameters investigated: total mass (- 5.68 kg), fat mass (- 4416.85 g), fat mass index (- 1724.56), visceral adipose tissue (- 332.76 g), arm circumference (- 1.63 cm) and calf circumference (- 1.16 cm). As it is reasonable to expect, even the fat free mass has been reduced (- 1236.03 g); however, the skeletal muscle index was not affected. Statistically significant improvement in glycaemic and lipid profile were reported. The BMI average reduction continued from discharge until T4. No statistically significant changes in fat free mass and visceral adipose tissue (VAT) were reported during a year of follow-up. CONCLUSIONS: The present study demonstrated the clinical benefits of 8-week MRP, which includes hypocaloric diet, physical exercise, and psychological support. LEVEL OF EVIDENCE: III, evidence obtained from cohort or case-control analytic studies.

Two, Six, and Twelve-Month Dropout Rate and Predictor Factors After a Multidisciplinary Residential Program for Obesity Treatment. A Prospective Cohort Study.

Introduction: The aim of the present study was to assess the dropout rate at 2, 6, and 12 months after an inpatient multidisciplinary residential program (MRP) for the treatment of obesity. Furthermore, this study assessed anthropometric and biochemical predictors associated with the dropout. Methods: Adult and elderly patients (age 59 ± 14 years) with obesity had undergone an MRP, were followed up from 2 to 12 months. Biochemical and anthropometric markers have been assessed at the beginning of the follow-up period after the MRP. Results: The study enrolled 178 subjects, 117 women and 61 men. The overall dropout rate at 2 months was 21.3%, after 6 months was 44.4%, and after 1 year was 68.5%. There was no difference by gender recorded. Furthermore, patients under medical treatment with psychiatric disorders did not show an association with the dropout rate. Patients with a higher level of body mass index (BMI) at the discharge of MRP showed +48% of dropout at 6 months. After the MRP, the baseline values of uricemia and white blood cells (WBCs) resulted as predictors of dropout at 2 months (p > 0.05). Furthermore, the excess percentage of fat mass lost during the MRP was associated with the risk of dropout at 2, 6, and 12 months (p > 0.05). Conclusion: The MRP for obesity is an opportunity for losing weight for patients with established criteria. The future challenge will be addressing the best strategic plans in order to reduce the dropout rate after this intervention. Investigating deeply the main predictors could be an opportunity to improve the long-term efficacy of MRP.

The Effect of Curcumin on Idiopathic Parkinson Disease: A Clinical and Skin Biopsy Study.

There are currently no standardized therapies for Parkinson disease (PD). Curcumin shows anti-amyloidogenic properties in vitro and may be a promising treatment for PD. We evaluated the effects of curcumin supplementation on clinical scales and misfolded, phosphorylated α-synuclein (p-syn) accumulation in skin biopsies in 19 PD patients who received curcumin supplementation for 12 months and 14 PD patients to treated with curcumin. The patients underwent autonomic (COMPASS-31), motor (MDS-UPDRS and H&Y) and nonmotor (NMSS) questionnaires and skin biopsies to evaluate clinical involvement and p-syn load in skin nerves at the beginning and the end of study. Curcumin and curcuminoid levels were assayed in plasma and CSF. Supplemented patients showed detectable CSF curcuminoid levels that were lower than those in plasma. They showed a decrease of COMPASS-31 and NMSS scores, and a slight p-syn load decrease versus untreated patients who displayed a worsening of these parameters despite increased levodopa doses. Multiple regression models showed a significant effect of curcumin supplementation in decreasing the worsening of the clinical parameters and p-syn load at after curcumin treatment. These data suggest that curcumin can cross the blood-brain barrier, that it is effective in ameliorating clinical parameters and that it shows a tendency to decrease skin p-syn accumulation in PD patients.

In Vitro and In Vivo Anticancer Activity of Basil (Ocimum spp.): Current Insights and Future Prospects.

BACKGROUND: Cancer is an irregular proliferation of cells that starts with a gene mutation that alters cellular function, is triggered by several factors, and can be inherited or acquired. The aim of this review is to discuss the anticancer activity of basil and its components' strength, focusing on its implication in cancer prevention and treatment. METHODS: This systematic review involves all of the studies published from 1 January 2010 through 1 January 2022. RESULTS: In this review, 16 research articles are included to discuss the potential anticancer ability of the extracts of various Ocimum basilicum varieties at various dosages, applied to different cancer cells. Of those 16 articles, 2 were in vivo studies, 13 were in vitro studies, and 1 study conducted both in vivo and in vitro experiments. Antioxidants and other bioactive compounds in basil leaves show important potential anticancer activity at dosage of 4 mg/mL as aqueous extract or essential oil up to 200 µg/mL could slow-down tumor growth and progression with regards to cell death and viability inhibition. At dosages from 50 to 500 µg/mL is effective as anti-proliferative activities. cytotoxicity, inducing apoptosis, slowing down tumor growth, and especially cell cycle arrest, both in vivo and in vitro. Human studies show effects at dosages from 1 to 2.5 mg/daily on general vital activities and on reducing cytokines activity. CONCLUSIONS: Based on 16 published studies, basil demonstrates important anticancer activities in vivo and vitro models, and it could act as a potential cancer.

Positive Effects of a Lecithin-Based Delivery Form of Boswellia serrata Extract in Acute Diarrhea of Adult Subjects.

Acute diarrhea is a frequent problem worldwide, mostly due to gastrointestinal infections or food poisoning. Boswellia serrata could be active in the treatment of acute diarrhea due to its anti-inflammatory, antispasmodic, and antimicrobial activity. In this randomized, double-blind, placebo-controlled clinical study, 49 adults with acute diarrhea were randomly allocated to receive 250 mg of a lecithin-based delivery form of Boswellia serrata (CASP) or placebo for 5 days. The time it took to become healthy with stoppage of diarrhea (primary end point) was significantly shorter in the intervention group (3.08 vs. 4.44 days: p-value < 0.0001). The probability of subjects treated with CASP to recover sooner was equal to 80.2%. A significantly lower number of stools was observed in the CASP group over time (ß = −0.17, p-value < 0.0001). A significant difference was observed between the two groups for abdominal pain, nausea, and GAE (global assessment of efficacy). In conclusion, the lecithin-based delivery form of Boswellia serrata extract could be a useful addition to the treatment of acute diarrhea in adults. CASP is safe and reduces the time it takes to become healthy, the frequency of stools, the abdominal pain and nausea of subjects with acute diarrhea. Further studies are needed to confirm these promising results.

Beneficial Effects on Abdominal Bloating with an Innovative Food-Grade Formulation of Curcuma longa and Boswellia serrata Extracts in Subjects with Irritable Bowel Syndrome and Small Bowel Dysbiosis.

Bloating is a symptom frequently reported by subjects with irritable bowel syndrome (IBS) and small bowel dysbiosis, and Low FODMAP's diet (LFD) has been used to treat them. Extracts of Curcumalonga and Boswelliaserrata share anti-inflammatory and antimicrobial effects that could be useful in the management of these clinical conditions. The aim of this study was to evaluate the efficacy of curcumin and boswellia extracts (as Curcumin Boswellia Phytosome, CBP) and LFD on the relief of abdominal bloating in IBS subjects with small bowel dysbiosis, in comparison to LFD alone, in a 30-day supplementation, randomized trial. IBS participants were randomized to either the intervention (500 mg bid of CBP and LFD) or control arm (LFD). Small bowel dysbiosis has been defined by an increase of urinary indican with normal urinary skatole. A total of 67 subjects were recruited. The intervention group (33 subjects) showed a significant decrease (p < 0.0001) of bloating, abdominal pain, and indican values at the end of the study, when compared to the control group (34 subjects). Moreover, the subjects of the intervention group showed a significantly better (p < 0.0001) global assessment of efficacy (GAE) as compared to controls. In conclusion, in subjects with IBS and small bowel dysbiosis, abdominal bloating can be successfully reduced with a supplementation with CBP and LFD.

Promising Effects of 3-Month Period of Quercetin Phytosome® Supplementation in the Prevention of Symptomatic COVID-19 Disease in Healthcare Workers: A Pilot Study.

Quercetin, for its crucial properties, fulfills the need for a multifactor action that is useful for the potential counterbalance of a COVID-19 infection. Given this background, the aim of the study was to evaluate the potential effect of 3 months' supplementation with Quercetin Phytosome® (250 mg twice a day) as prevention against symptomatic COVID-19. In total, 120 subjects were enrolled (males, 63; females, 57; age 49 ± 12), with 60 in the supplementation group and 60 in the placebo group. No significant differences were detected between groups in terms of gender, smoking, and chronic disease. Subjects underwent rapid COVID-19 diagnostic tests every 3 weeks. During our study, 5 subjects had COVID-19, 1 out of 60 subjects in the quercetin group and 4 out of 60 in the control group. Complete clinical remission was recorded at 7 and 15 days in the quercetin and placebo groups, respectively. Analysis showed that, at 5 months, the COVID free survival function (risk of infection) was 99.8% in subjects under quercetin supplementation and 96.5% in control group. As shown by the value of EXP(B), those who had taken the supplement had a protection factor of 14% more to not contract the COVID-19 infection than that of those who had taken a placebo. Obtained results are encouraging, but further studies are required to add quercetin as regular prophylaxis.

Curcumin Supplementation (Meriva®) Modulates Inflammation, Lipid Peroxidation and Gut Microbiota Composition in Chronic Kidney Disease.

Chronic kidney disease (CKD) subjects suffer from high risk of cardiovascular mortality, and any intervention preventing the progression of CKD may have an enormous impact on public health. In the last decade, there has been growing awareness that the gut microbiota (GM) can play a pivotal role in controlling the pathogenesis of systemic inflammatory state and CKD progression. To ameliorate the quality of life in CKD subjects, the use of dietary supplements has increased over time. Among those, curcumin has demonstrated significant in vitro anti-inflammatory properties. In this pilot study, 24 CKD patients and 20 healthy volunteers were recruited. CKD patients followed nutritional counselling and were supplemented with curcumin (Meriva®) for six months. Different parameters were evaluated at baseline and after 3-6 months: uremic toxins, metagenomic of GM, and nutritional, inflammatory, and oxidative status. Curcumin significantly reduced plasma pro-inflammatory mediators (CCL-2, IFN-γ, and IL-4) and lipid peroxidation. Regarding GM, after 6 months of curcumin supplementation, Escherichia-Shigella was significantly lower, while Lachnoclostridium was significant higher. Notably, at family level, Lactobacillaceae spp. were found significantly higher in the last 3 months of supplementation. No adverse events were observed in the supplemented group, confirming the good safety profile of curcumin phytosome after long-term administration.