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The aim of this study was to test the clinical and mucosal benefit of a natural gastro-oesophageal mucosal protector DOGDG-121 in non-erosive GERD comprising from NERD....

The aim of the present study was to test either a previously studied symbiotic, a novel probiotic mixture or a sequence symbiotic-probiotic schedule in beneficially affecting gut health parameters in otherwise healthy stressed individuals. This was a multicenter randomized study with no gender selection. A total of hundred-twenty individuals aged between 38 and 62 years were recruited for this study. Patients were selected to have an overall positive attitude towards their personal life and work but reporting high-demanding job activity regarded as stressful. Three age and gender-matched groups (40 pts each) were considered: A) given a symbiotic 10 ml t.i.d. for 5 months; B) given 1 tab t.i.d of P3T/J (a probiotic mixture) for 5 months and C) given the symbiotic 10 ml t.i.d. for 1 month and then shifted to 1 tab t.i.d of probiotic mixture for 4 months. A forth group (group D) of 20 healthy, stressed individuals coming from a prior study, supplemented a marine PUFA extract served as treatment control (a sturgeon-based fish collagen, Caviarlieri, Swiss cap packaging, Switzerland). As compared to baseline and all other groups, group C showed a significant decrease of morning salivary cortisol at awakening. When plotting these values against the STAI scores, it appeared a significant correlation (r:0.66, p B). Values of serum zonulin showed a wide scattering in all groups and by clustering those individuals, who were engaged in regular moderateintense physical activity, the baseline concentration of zonulin was higher as compared to the rest of the population and it occurred a remarkably lower level of zonulin with C schedule. Fecal parameters in B and C group showed a statistically significant reduction of β-glucuronidase at 2 months (p

The present study was designed to determine whether DTS a phytocompound endowed with antioxidant properties, could beneficially modulate nitric oxide (NO) production stimulated by lipopolysaccharide (LPS) and tumor necrosis factor-alpha (TNF-alpha) in adipocytes. Combined stimulation (CS-treatment) exerted by using 5 microg/ml of LPS together with 100 ng/ml of TNF-alpha significantly enhanced NO production in 3T3-L1 adipocytes. Preincubation of the adipocytes with DTS (10-30 mM) inhibited such phenomenon in a dose-dependent fashion. The production of NO was decreased by 52% at the concentration of 30mM of DTS. The decrease in NO production by DTS was associated also with a decrease in inducible nitric oxide synthase (iNOS) protein and iNOS mRNA expression. Nuclear factor-kappa B (NF-kappaB) was significantly enhanced by CS-treatment, while the pretreatment with 30 mM of DTS prevented the activity by 27%. IL-6 production in 3T3-L1 adipocytes was markedly increased by CS stimulus, and the enhanced secretion of IL-6 was suppressed in a dose-dependent manner by DTS. These results suggest that DTS regulates iNOS expression and NO production in adipocytes through the modulating activation of NF-kappaB and may have a potential clinical application within protocols designed for treating metabolic syndrome. (www.actabiomedica.it).

To the Editor: It is still a matter of debate whether Helicobacter pylori (H. pylori) causes symptoms in idiopathic dyspepsia because no clear indication came out from epidemiological or interventional studies (1). However, some authors observed that H. pylori infection in idiopathic dyspepsia patients is associated with epigastric pain (2, 3). A considerable number of studies has demonstrated that H. pylori strains harbouring the CagA gene are more virulent that CagA negative strains, for being more frequently associated to peptic ulcer. However, little is known as to whether CagA positive strains are associated with the occurrence of symptoms in dyspeptics. We recently conducted a large epidemiological study on the serological and histological prevalence of H. pylori infection in 3,281 patients throughout Italy undergoing endoscopy for the first time (4). At enrollment, a 10 ml blood sample was taken from each participant in the study for the determination of anti-H. pylori IgG and anti-CagA reactivity by a commercial ELISA assay (Eurospital, Trieste, Italy). Together with endoscopic diagnosis, the presence of five dyspeptic symptoms was recorded in these patients (present or absent), namely, belching, pyrosis, postprandial fullness, vomiting, and epigastric pain. After exclusion of patients with gastric cancer or borderline serology, a series of 3,163 patients with idiopathic dyspepsia, peptic ulcer, or esophagitis were available for multivariate analysis; the presence of epigastric pain was strongly associated with the diagnosis of duodenal and gastric ulcer (OR 6.03, p < 0.001; OR 2.67, p < 0.001, respectively). This association also persisted in a model adjusted for H. pylori infection. No association was observed between any of the above-mentioned symptoms and esophagitis.

The aim of the present study was to test the possible effects of a novel sturgeon-derived compound (LD-1227) on inflammatory markers related to metabolic nuclear receptors in patients with metabolic syndrome. The study population consisted of 76 patients with metabolic syndrome and 30 healthy subjects who were maintained to their current treatments and randomly supplemented: A) LD-1227 (n=38) or B) placebo (n=38) as compared to C) healthy controls (n=30). LD-1227 or placebo (water-soluble starch) were given daily at breakfast and dinner for three months. Levels of hs-CRP, IL-6, TNF-α, leptin and adiponectin/ resistin index were assayed at the entry, 1 month and 3 months afterwards. At the end of the study period, as compared to B group, LD-1227-treated patients showed a significant improvement of all parameters tested, irrespective of the presence of diabetes. In particular, levels of adiponectin and adiponectin/ resistin index significantly increased following LD-1227 administration. Although the metabolic syndrome remains a multifaceted condition requiring a complex approach, LD-1227 could be a potential safe therapeutic tool to be integrated into a wider treatment and preventive medicine schedule strategy.

"Functional foods" represent an emerging opportunity and they will certainly play a consistent and important role in future too. Such a new perspective entirely depends on the growing attention paid by nutritionists to the development of new innovating solutions aiming at acting on organic systems as well as on more general topics relating to consumer good health conditions. Differently from the past, when mainly retrospective epidemiological studies or empirical experiences were carried out on single nutrients, such a new and growing interest by the scientific community follows research deeply oriented to clinics supplemented by an accurate study on nutrients, genomics and single nutritional requirement diagnostics. Already in 1993, the leading journal Nature published a report "Japan is exploring limits between food and medicine" (Swinbanks 1993). Clearly the success of "Functional foods" depends on the food industry capacity too of developing new effective products which on the one side meet any consumer request and on the other must be have positive effects on health, supported and validated by scientific research and therefore far beyond simple positive properties, as recently underlined in a meeting, organised by a no profit non governmental international association.

The purpose of this study was to assess the effect of Celergen, a marine nutraceutical, against tumor cell invasion in human pancreatic cancer cell line (PSN-I). High invasive clone (HI) and low invasive clone (LI) were established from wild type PSN-l cell line after a repeated invasion assay test. The invasive ability of HI cells and the level of IL-6 in the conditioned medium of HI cells was significantly higher than that one of LI cells but both these parameters were significantly reduced by the addition of Celergen (p0.01). Exogenous IL-6 administration induced a dose dependent enhancement of invasive ability in both cell populations. Moreover, IL-6 receptor expression was detected in 72% of HI cells whereas this occurred only in 37% of LI cells. When co-cultured with Celergen this parameter was significantly downregulated in both cellular subsets (p0.05). The addition of conditioned medium derived from HI cells (HCM) and LI cells(LCM) enhanced the invasive ability in both cell populations without affecting cell proliferation. The effect of HCM on the invasive ability of HI cells was partially inhibited by the addition of Celergen (p0.01). In summary, overexpression of IL-6 and its receptor may be one relevant factor contributing to the highly invasive characteristic of the pancreatic cancer cell line we used while a significantly beneficial modulation was obtained by applying this novel marine nutraceutical. This advices to further explore the possibility of marine compounds regulation of IL-6 ligand/receptor and other possible invasive factor interaction in the therapy of this malignancy while further studies are awaited in this setting.

Alkylglycerols have shown immune stimulant and adjuvant activity in several studies and the aim of the present research was to assess in particular the effect of shark liver-derived alkylglycerols on gut immune system. C57BL/6 mice, fed under specific pathogen free conditions, were randomly divided into two groups: (a) fed normal laboratory food or (b) added with alkylglycerols (2 mg/day/mouse) for 3 weeks. Intraepithelial lymphocytes (IEL) were retrieved from the small intestine and tested for NK and tumor cytotoxicity. Lymphocytes from liver, spleen and IEL were also assessed as for their counting and phenotypic characterization. Under supplementation with alkylglycerols, the number of lymphocytes yielded by the small intestine increased by to almost 40%. Moreover, the ratio of CD8alphabeta+TCRalphabeta+ cells/CD8alphaalpha+TCRalphabeta+ cells remarkably increased. In parallel with this reshaping in the distribution of lymphocyte subsets, tumor cytotoxicity of IEL against P815 cells and cytokine production from circulating lymphocytes were also enhanced. These data show that phylogenetically developed lymphocytes (CD8alphabeta, TCRalphabeta+) were significantly activated by the oral administration of alkylglycerols. The present results indicate that purified alkylglycerols might have such significant potential via the enhancement of intestinal immunity, especially in the small intestine.

RE-START is a multicenter, randomized, prospective, open, controlled trial aiming to evaluate the feasibility and the short- and medium-term effects of an early-start AET program on functional capacity, symptoms and neurohormonal activation in chronic heart failure (CHF) patients with recent acute hemodynamic decompensation. Study endpoints will be: 1) safety of and compliance to AET; 2) effects of AET on i) functional capacity, ii) patient-reported symptoms and iii) AET-induced changes in beta-adrenergic receptor signaling and circulating angiogenetic and inflammatory markers. Two-hundred patients, randomized 1:1 to training (TR) or control (C), will be enrolled. Inclusion criteria: 1) history of systolic CHF for at least 6 months, with ongoing acute decompensation with need of intravenous diuretic and/or vasodilator therapy; 2) proBNP > 1000 pg/mI at admission. Exclusion criteria: 1) ongoing cardiogenic shock; 2) need of intravenous inotropic therapy; 3) creatinine > 2.5 mg/dl at admission. After a 72-hour run-in period, TR will undergo the following 12-day early-start AET protocol: days 1-2: active/passive mobilization (2 sessions/day, each 30 minutes duration); days 3-4: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 5-10 minutes duration); days 5-8: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 15-20 minutes duration); days 9-12: as days 1-2 + bedside cycle ergometer at 10-20 W (3 sessions/day, each 15-20 minutes duration). During the same period, C will undergo the same activity protocol as in days 1-2 for TR. All patients will undergo a 6-min WT at day 1, 6, 12 and 30 and echocardiogram, patient-reported symptoms on 7-point Likert scale and measurement of lymphocyte G protein coupled receptor kinase, VEGF, angiopoietin, TNF alfa, IL-1, IL-6 and eNOS levels at day 1, 12 and 30.

Hepatic fibrosis is a widespread alteration in the liver that primarily consists of increased collagen deposition in the tissue. The aim of the present study was to evaluate the protective effects of poly-phytocompound EH-1501 containing small amounts of silymarin but also other potentially effective substances on thioacetamide (TTA)-induced liver fibrosis and to elucidate the mechanisms underlying these protective effects in rats. Forty rats were randomly divided into four groups. Liver fibrosis was induced by intraperitoneal injection of 200 mg/kg body weight. TAA dissolved in saline was administered thrice a week, for 8 weeks. Groups 1 (normal healthy control) and 2 (liver injury model) received water for 8 weeks or silymarin (50 mg/kg p.o. daily) for 8 weeks (group 3) or a poly-phytocompound EH-1501 (containing grape leaf, wild strawberry, dandelion and milk thistle, EuroHealth, Italy) (200 mg/kg, daily respectively) for 8 weeks (group 4). Biochemistry and serum fibrosis markers were AST, ALT, GGT, bilirubin, thiobarbituric acid reactive substances (TBARs), hyaluronic acid and type IV collagen 7s. Liver tissue was used to assay glutathione peroxidase (GPx), catalase (CAT), superoxide dismutase (SOD), TBARs, hydroxyproline and gene expression of collagen alpha1 (col alpha1) and transforming growth factor-beta1 (TGF-beta1). Silymarine and EH-1501 were equally effective in reducing serum markers of liver damage and fibrosis as well as oxidative stress. However, as compared to silymarine, EH-1501 was significantly more effective in improving tissue level of GPx while decreasing TBARs and hydroproline content (p0.05). When looking at gene expression of col alpha1 and TGF-beta1, EH-1501 showed a significantly higher degree of gene down-regulation as compared to silymarine (p0.05). Taken altogether, these data suggest that a natural antioxidant-containing phytocompound EH-1501 exerts an effective hepatoprotective property in experimental chronic fibrotizing liver injury to a significantly higher degree than silymarin.

This study aims to determine the effects of different alkaline supplementations on high protein diet-induced abnormalities affecting bone metabolism in rats which were also undergoing physical exercise of moderate intensity. Sixty elderly Sprague-Dawley rats were randomly divided into four groups of 10 rats each and treated for 16 weeks as follows: baseline control group fed normal food (C); acidic high-protein diet supplemented group (chronic acidosis, CA group), bicarbonate-based alkaline formula (Basenpulver, Named, Italy) supplemented chronic acidosis (BB-CA) and citrate-based alkaline supplement (CB-CA). Throughout the supplementation period, rats were put on a treadmill training mimicking a moderate level of exercise. In the CA group, 24-hour urinary calcium (Ca) and phosphorus (P) excretion were increased over 30 percent (p0.05 vs normal diet controls). However serum Ca was not significantly changed. Femural and tibial BMD and BMC was significantly decreased in the CA group (p0.05) but both alkaline supplementations prevented such phenomenon (p0.05 vs CA), without significant difference between the two formulations although the BB-CA group showed significantly more preserved trabecular bone volume (p0.05 vs CB-CA group). An increased level of over 50 percent of urinary Dpd observed in the CA group (p0.001) was reverted to normal by both supplementations (p0.001 vs CA group). The same applied to urinary net acid excretion (p001) with BB-supplementation performing better than CB-supplementation (p0.05). Moreover, while the latter did not modify Nterminal telopeptide value, BB-supplementation significantly normalized this parameter (p0.05 vs CA group) which exercise and acidic protein diet had modified (p0.01 vs control diet). Overall, the present study shows that a bicarbonate-based alkaline formula, when administered to a dose amenable to clinical use, may significantly protect bone structure in exercising aged animals to a greater extent than a quali/quantitavely similar citrate-based formula.

Osteoarthritis (OA) is a slow, chronic joint disease characterized by focal degeneration of articular cartilage and alterations of the chemical and mechanical articular function and also major cause of pain and physical disability. There is clinical evidence that increasing dietary n-3 relative to n-6 may be beneficial in terms of symptom management in humans but not all studies conclude that dietary n-3 PUFA supplementation is of benefit, in the treatment of OA. Our recent studies highlight the effect of a biomarine compound (LD-1227) on MMPs, collagen metabolism and on chondrocyte inflammatory markers. Thus, the aim of the present work was to test such bioactive compound versus a common nutraceutical intervention (glucosamine/chrondroitin sulfate) in knee osteoarthritis patients. The patients population consisted of 60 subjects with a recent diagnosis of knee osteoarthririts of mild-moderate severity. Patients were randomized in a double-blind study comparing LD-1227 (group A) versus a mixture of glucosamine (500 mg), chondroitin sulfate (400 mg) (group B). Patients were allowed their established painkillers on demand. At 4, 9 and 18 weeks patients were evaluated as for: VAS score assessing pain at rest, and during physical exercise, Lequesne index, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and KOOS scale. Moreover, serum concentrations of IL-6, IL-β, CRP, TNF-sR1 and TNF-sR2 were assessed. As compared to GC treatment, LD-1227 yielded a quicker and higher degree of improvement of the whole clinical indexes and a lower NSAIDs use at the end of the study. LD-1227 brought about also a more significant downregulation of the tested cytokines cascade. Taken overall, these data suggest that LD-1227 has the potential to be included in the nutraceutical armamentarium in the management of OA.

In the present study, we examined the effect of a marine bioactive compound containing high-purity caviar-derived DNA, collagen elastin and protein extracts from sturgeon (LD-1227, Caviarlieri, Laboratoires Dom, Switzerland) on ILβ-induced activation and production of TNFα and MMP-13 in human osteo-arthritis (OA) chondrocytes and intracellular signaling factors. Human chondrocytes were derived from OA cartilage and stimulated with ILβ. Gene expression of TNFα, MMP-13, MMP-1 and Co110Al was measured by quantitative RT-PCR. TNFα protein in culture medium was determined using cytokine-specific ELISA. Western immunoblotting was used to analyze the MMP-13 production in the culture medium and the activation of NF-κB. DNA binding activity of NF-κB p65 was determined using a highly sensitive and specific ELISA. MMP-13 activity in the culture medium was assayed by gelatine zymography. LD-1227 significantly decreased ILβ-stimulated gene expression and production of TNFα, MMP-1, MMP-13 and Co110Al in human chondrocytes. The inhibitory effect of LD-1227 on the ILβ-induced expression of these genes was mediated at least in part via suppression of NF-κB p65. These data show that LD-1227 can inhibit IL-lβ-induced proliferation and inflammatory reactions via inhibited activation of the transcription factor NF-κB pathway in human chondrocytes derived from OA patients. These novel pharmacological actions of LD-1227 on ILβ-stimulated human OA chondrocytes provide suggestions that this marine biology compound may inhibit cartilage degradation by suppressing ILβ-mediated activation and the catabolic response in human chondrocytes. Copyright © by BIOLIFE, s.a.s.