Designing New Sport Supplements Based on Aronia melanocarpa and Bee Pollen to Enhance Antioxidant Capacity and Nutritional Value.

With a high number of athletes using sport supplements targeting different results, the need for complex, natural and effective formulations represents an actual reality, while nutrition dosing regimens aiming to sustain the health and performance of athletes are always challenging. In this context, the main goal of this study was to elaborate a novel and complex nutraceutical supplement based on multiple bioactive compounds extracted from Aronia melanocarpa and bee pollen, aiming to support physiological adaptations and to minimize the stress generated by intense physical activity in the case of professional or amateur athletes. Our proposed formulations are based on different combinations of Aronia and bee pollen (A1:P1, A1:P2 and A2:P1), offering personalized supplements designed to fulfill the individual requirements of different categories of athletes. The approximate composition, fatty acid profile, identification and quantification of individual polyphenols, along with the antioxidant capacity of raw biological materials and different formulations, was performed using spectrophotometric methods, GS-MS and HPLC-DAD-MS-ESI+. In terms of antioxidant capacity, our formulations based on different ratios of bee pollen and Aronia were able to act as complex and powerful antioxidant products, highlighted by the synergic or additional effect of the combinations. Overall, the most powerful synergism was obtained for the A1:P2 formulation.

The clinical effect of benesco™ on reflux symptoms: A double-blind randomized placebo-controlled trial.

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases in the western world. Lifestyle modifications and proton pump inhibitors (PPIs) form the basis of the management of GERD. A subset of patients seeks for (natural) alternative therapies besides PPIs. benesco™ is an over-the-counter nutrition based on quercetin which has a presumed positive effect on esophageal barrier function. Therefore we aim to assess the effect of benesco™ on reflux symptoms. METHODS: We performed a double-blind randomized placebo-controlled trial in participants with reflux symptoms. Participants were assigned randomly (1:1) to receive 6 weeks of benesco™ (three times daily one lozenge containing 200 mg of quercetin) or placebo. The primary outcome was treatment success (≥50% reduction in Reflux Disease Questionnaire Score). Secondary outcomes included GERD-related quality of life, reflux-free days and nights, and participant-reported treatment success. KEY RESULTS: One hundred participants were randomized. Treatment success was seen in 18 (39%) of 46 participants in the intervention group versus 21 (47%) of 45 in the placebo group (p = 0.468). In the intervention group 10 (1-21) reflux-free days were reported compared to 10 (2-25) in the placebo group (p = 0.673). In addition, 38 (34-41) versus 39 (35-42) reflux-free nights were reported (p = 0.409). CONCLUSIONS & INFERENCES: In our trial benesco™ showed no significant benefit over placebo at group level.

Thymoquinone Modulates Blood Coagulation in Vitro via Its Effects on Inflammatory and Coagulation Pathways.

Thymoquinone (THQ) is a major component of black seeds. Given that both THQ and black seeds exhibit anti-cancer and anti-inflammatory activities, we hypothesized that THQ will affect cancer-associated thrombosis (CAT), which is primarily triggered by tissue factor (TF) and inflammation. The effect of both black seed-extracted and purchased ("pure") THQ on normal blood coagulation was tested with in vitro thromboelastography (TEG) and activated partial thromboplastin time (aPTT) coagulation assays. The effect of pure THQ on CAT was tested with aPTT assay using pancreatic cancer cell lines that are either positive or negative for TF, and with TEG assay using lipopolysaccharide as an inflammatory trigger. Additionally, the direct effect of THQ on the inactivation of factors IIa and Xa was assessed. Since TNF-α facilitates crosstalk between inflammation and thrombosis by triggering the NF-κB pathway, we tested THQ's ability to interfere with this communication with a luciferase assay. Both extracted and pure THQ had minimal effects on normal blood coagulation. Pure THQ reversed CAT initiated by both TF and inflammation to basal levels (p < 0.001). Mechanistically, while THQ had minimal to no effect on factor IIa and Xa inactivation, it strongly reduced the effects of TNF-α on NF-κB elements (p < 0.001). THQ has a minimal effect on basal coagulation and can reverse CAT in vitro, possibly by interfering with the crosstalk between inflammation and coagulation. This study suggests the utility of THQ as a preventative anticoagulant and/or as a supplement to existing chemotherapies and anticoagulant therapies.

Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

OBJECTIVE: Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. METHODS: Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. RESULTS: Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. CONCLUSION: SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard.

Effect of a Natural Supplement Containing Curcuma Longa, Guggul, and Chlorogenic Acid in Patients With Metabolic Syndrome.

The impact of a natural supplement (Kepar; Rikrea, Italy), containing several plant extracts such as curcuma longa, silymarin, guggul, chlorogenic acid, and inulin, was evaluated in 78 patients with metabolic syndrome (MetS; 45 men; age: 62 ± 9 years). Kepar at a dose of 2 pills/d was given for 4 months as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study. Anthropometric variables, plasma lipids, glucose parameters, and oxidative stress were measured at baseline and after 4 months. We found significant reductions in body weight (from 81.1 ± 13.5 to 79.4 ± 12.5 kg, P < .0001), body mass index (from 29.6 [23.7] to 29.3 [21.9] kg/m(2), P = .001), and waist circumference (from 105 ± 11 to 102 ± 10 cm, P = .0004) as well as in fasting glucose (from 6.5 [11.7] to 6.4 [7.6] mmol/L, P = .014) and total cholesterol (from 4.8 ± 1.4 to 4.5 ± 1.0 mmol/L, P = .03). No significant changes were found in the other appraised parameters, including oxidative stress. In conclusion, after few months of treatment Kepar seems to exert beneficial effects in patients with MetS. Larger studies with a longer follow-up period are needed to confirm these preliminary findings.