The Impact of Abdominal Body Contouring Surgery on Physical Function After Massive Weight Loss: A Pilot Prospective Matched Comparison.

BACKGROUND: Many individuals develop excess skin (ES) following massive weight loss (MWL). Patient-reported outcomes demonstrate that abdominal ES negatively impacts perceived physical function which is improved by abdominal body contouring surgery (ABCS). However, the effect of ABCS on objective measures of physical function is unknown. OBJECTIVES: The aim of this study was to examine the impact of ABCS on objective measures of physical function in individuals who have undergone MWL. METHODS: Patients who have undergone MWL with abdominal ES (grade, ≥2) underwent the following physical function assessments: 9-item modified physical performance test (mPPT), chair stand, star excursion balance test (SEBT), timed up and go (TUG), modified agility T test, and 6-minute walk test (6-MWT). Perception of physical exertion and BODY-Q questionnaire scales were also collected. Nonsurgical controls (n = 21) and those who had undergone ABCS (n = 6) after the first visit performed a second physical function assessment 8 to 12 weeks later to allow for postoperative healing. RESULTS: No ceiling or floor effect was detected for any physical function measure. The intraclass correlation coefficient was 0.78 (95% CI, 0.44, 0.91) for the mPPT and >0.80 for all other measures. The effect sizes were 0.74 (75% CI, 0.19, 1.28) for the mPPT, 0.54 (75% CI, 0.00, 1.08) for the SEBT, -0.63 (75% CI, -1.17, -0.09) for the modified agility T test, and 0.79 (75% CI, 0.24, 0.13) for the 6-MWT. CONCLUSIONS: The mPPT and tests involving dynamic balance, agility, and walking were reliable and showed medium to large effect sizes, suggesting that these tests may be sensitive to change following ABCS.

Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes.

PURPOSE: Soluble fibre beneficially affects metabolism but whether it can augment the reductions in glycemia induced through intensive weight management has not been extensively studied. Our objective was to examine the adjunct effect of the soluble viscous fibre PGX® on glycemic control in adults with type 2 diabetes (T2D) enrolled in a year-long medically supervised weight management program. METHODS: In a placebo-controlled, double-blind study, 290 adults with overweight/obesity and T2D were randomized to receive PGX (15-20 g/day) or isocaloric placebo (rice flour, 6.4-8.6 g/day) as an adjunct to intensive weight management for 52 weeks. The primary outcome was change in glycemic control (HbA1c). Other outcome measures included weight loss, blood lipids, blood pressure, cytokines and fecal microbiota. RESULTS: Compared to baseline HbA1c in PGX (7.2 ± 1.1%) and placebo (7.0 ± 0.9%) groups, there was a significant reduction at 16 and 26 weeks, however, only PGX showed a significant absolute reduction of 0.23% at 52 weeks; there were no between-group differences in HbA1c. At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points. Compared to baseline, only PGX showed a significant reduction in LDL cholesterol at 16 and 26 weeks. PGX significantly increased the relative abundance of Collinsella, Parabacteroides and Roseburia. CONCLUSION: Adding PGX to a weight management program for individuals with T2D provides a sustained reduction in HbA1c compared to placebo. Improvements in other metabolic outcomes suggest that PGX may be a promising adjunct to weight loss programs in patients with T2D. CLINICAL TRIAL: This trial was registered at ClinicalTrials.gov as NCT01644201.

Telerheumatology: The VA Experience.

OBJECTIVES: We sought to characterize the correlation between diagnoses made during telerheumatology and face-to-face visits and to document patients' satisfaction with telerheumatology visits. METHODS: This quality assurance study of the use of telerheumatology evaluated new patients referred to a Veterans Affairs rheumatology clinic. Patients were seen at a community clinic by a nurse practitioner with a rheumatologist participating in the encounter via telelink. All of the patients had a second face-to-face visit with the same rheumatologist. Diagnoses made during telerheumatology and face-to-face visits were compared. Patients' satisfaction with telerheumatology was ascertained. RESULTS: Thirty-eight patients were included in the study. Initially, 23 were diagnosed as having an inflammatory or rheumatic condition; 15 were subsequently confirmed at the face-to-face visits. All of the patients with inflammatory, rheumatic conditions were identified at the telerheumatology visits. The overall correlation was 79% between the telerheumatology and face-to-face visits. Among patients with inflammatory, rheumatic conditions, 66% preferred a face-to-face visit compared with 41% among those without such conditions (not significant). Immediately after the telerheumatology visit, all of the patients gave a 10 out of 10 rating for satisfaction. During the subsequent telephone survey, 30 remained highly satisfied with the telemedicine encounter (10 out of 10 rating). CONCLUSIONS: Telerheumatology at the Palo Alto Veterans Affairs was well received by patients; provided an accurate diagnosis of noninflammatory, nonrheumatic conditions; and may be appropriate for screening and prioritizing patients for in-person rheumatology clinics.

25-Hydroxyvitamin D concentrations in children with Crohn's disease supplemented with either 2000 or 400 IU daily for 6 months: a randomized controlled study.

OBJECTIVES: To assess vitamin D status of pediatric patients with Crohn's disease (CD) and to compare their serum 25-hydroxyvitamin D (s-25OHD) with established cutoffs and assess whether 6 months of supplementation with 2000 IU/d, vs 400 IU/d, would reduce the group prevalence of vitamin D below these cutoffs. STUDY DESIGN: Subjects 8-18 years (n = 83) with quiescent CD were randomized to either 400 or 2000 IU vitamin D3/d for 6 months. RESULTS: Baseline mean ± SD s-25OHD was 24 ± 8 ng/mL; 13 subjects (16%) had an s-25OHD <16 ng/mL, 27 (33%) < 20 ng/mL, and 65 (79%) < 30 ng/mL. There was no significant difference between groups in achieving the cutoffs of 16 ng/mL or 20 ng/mL at 6 months; however, only 35% of the 400 IU group achieved the greater cutoff of 30 ng/mL compared with 74% in the 2000 IU group (P < .001). Baseline adjusted mean s-25OHD concentrations at 6 months were 9.6 ng/mL (95% CI 6.0-13.2, P < .001) greater in the 2000 IU than the 400 IU group. Disease activity was not affected by supplement dose. Few subjects exceeded safety marker cutoffs, and this did not differ by dose. CONCLUSIONS: At baseline, a high proportion of patients had a mean s-25OHD >20 ng/mL. 2000 IU vitamin D3/d is more effective in raising s-25OHD concentrations to > 30 ng/mL in children with CD than 400 IU/d, but both treatments were equally effective at achieving 16 or 20 ng/mL.

Dose-response effect of a novel functional fibre, PolyGlycopleX(®), PGX(®), on satiety.

The objective of this research was to determine the dose-response effects of a palatable, viscous and gel forming fibre, PolyGlycopleX(®) (PGX(®)), [(α-D-glucurono-α-manno-ß-D-manno-ß-D-gluco), (α-Lgulurono-ß-D mannurono), (ß-D-gluco-ß-D-mannan)] on satiety, and to gain insight into the underlying mechanisms that lead to appetite inhibition. Healthy subjects (n = 10), aged between 20.3 and 29.2 years, consumed PGX(®), in granular form at 2.5, 5.0 and 7.5 g, and a 5g inulin control, with a standard breakfast. The PGX(®) doses of 2.5 and 7.5 g mixed with water at the start of breakfast increased satiety (iAUC of 140.0 and 157.7, P = 0.025 and 0.001, respectively) compared to the control. The most effective dose (7.5g) was palatable and corresponded to a 34% increase in fullness, measured using a visual analogue scale and incremental area under the curve, and resulted in a delayed postprandial glycaemic response when compared with the control.

Identification of strains of RotaTeq rotavirus vaccine in infants with gastroenteritis following routine vaccination.

BACKGROUND: RotaTeq vaccine was introduced into the Australian National Immunisation Program in 2007. This study identified and characterised rotavirus strains excreted by infants who presented with symptoms of gastroenteritis following recent RotaTeq vaccination. METHODS: Fecal samples (N = 61) from children who developed gastroenteritis following recent RotaTeq vaccination were forwarded to the Australian Rotavirus Surveillance Program (ARSP). RotaTeq-positive samples were genotyped and regions of the VP3, VP4, VP6, and VP7 genes were sequenced. Also, 460 rotavirus-positive ARSP routine surveillance samples were analyzed by dot-blot Northern hybridization to detect RotaTeq vaccine-derived strains circulating in the community. RESULTS: Thirteen of the 61 samples collected from infants developing gastroenteritis after RotaTeq vaccination contained vaccine-derived (vd) rotavirus strains. Of these, 4 contained a vdG1P[8] strain derived by reassortment between the G1P[5] and G6P[8] parental vaccine strains. Northern hybridization analysis of 460 surveillance samples identified 3 samples that contained RotaTeq vaccine-derived strains, including 2 vdG1P[8] reassortant vaccine strains. CONCLUSIONS: During replication and excretion of RotaTeq vaccine, reassortment of parental strains can occur. Shedding of RotaTeq vaccine strains in 7 of 13 infants was associated with underlying medical conditions that may have altered their immune function. The benefits of vaccination outweigh any small risk of vaccine-associated gastroenteritis.

Sitagliptin reduces hyperglycemia and increases satiety hormone secretion more effectively when used with a novel polysaccharide in obese Zucker rats.

The novel polysaccharide (NPS) PolyGlycopleX (PGX) has been shown to reduce glycemia. Pharmacological treatment with sitagliptin, a dipeptidyl peptidase 4 (DPP4) inhibitor, also reduces glycemia by increasing glucagon-like peptide-1 (GLP-1). Our objective was to determine if using NPS in combination with sitagliptin reduces hyperglycemia in Zucker diabetic fatty (ZDF) rats more so than either treatment alone. Male ZDF rats were randomized to: 1) cellulose/vehicle [control (C)]; 2) NPS (5% wt:wt)/vehicle (NPS); 3) cellulose/sitagliptin [10 mg/(kg · d) (S)]; or 4) NPS (5%) + S [10 mg/(kg · d) (NPS+S)]. Glucose tolerance, adiposity, satiety hormones, and mechanisms related to DPP4 activity and hepatic and pancreatic histology were examined. A clinically relevant reduction in hyperglycemia occurred in the rats treated with NPS+S (P = 0.001) compared with NPS and S alone. Blood glucose, measured weekly in fed and feed-deprived rats and during an oral glucose tolerance test, was lower in the NPS+S group compared with all other groups (all P = 0.001). At wk 6, glycated hemoglobin was lower in the NPS+S group than in the C and S (P = 0.001) and NPS (P = 0.06) groups. PGX (P = 0.001) and S (P = 0.014) contributed to increased lean mass. Active GLP-1 was increased by S (P = 0.001) and GIP was increased by NPS (P = 0.001). Plasma DPP4 activity was lower in the NPS+S and S groups than in the NPS and C groups (P = 0.007). Insulin secretion and ß-cell mass was increased with NPS (P < 0.05). NPS alone reduced LDL cholesterol and hepatic steatosis (P < 0.01). Independently, NPS and S improve several metabolic outcomes in ZDF rats, but combined, their ability to markedly reduce glycemia suggests they may be a promising dietary/pharmacological co-therapy for type 2 diabetes management.

Effects of added PGX®, a novel functional fibre, on the glycaemic index of starchy foods.

The development of lower-glycaemic index (GI) foods requires simple, palatable and healthy strategies. The objective of the present study was to determine the most effective dose of a novel viscous fibre supplement (PGX®) to be added to starchy foods to reduce their GI. Healthy subjects (n 10) consumed glucose sugar (50 g in water × 3) and six starchy foods with a range of GI values (52-72) along with 0 (inert fibre), 2.5 or 5 g granular PGX® dissolved in 250 ml water. GI testing according to ISO Standard 26,642-2010 was used to determine the reduction in GI. PGX® significantly reduced the GI of all six foods (P < 0.001), with an average reduction of 19 % for the 2.5 g dose and 30 % for the 5 g dose, equivalent to a reducing the GI by 7 and 15 units, respectively. Consuming small quantities of the novel functional fibre PGX®, mixed with water at the start of a meal, is an effective strategy to reduce the GI of common foods.

Single-agent inhibition of Chk1 is antiproliferative in human cancer cell lines in vitro and inhibits tumor xenograft growth in vivo.

Chk1 is a serine/threonine kinase that plays several important roles in the cellular response to genotoxic stress. Since many current standard-of-care therapies for human cancer directly damage DNA or inhibit DNA synthesis, there is interest in using small molecule inhibitors of Chk1 to potentiate their clinical activity. Additionally, Chk1 is known to be critically involved in cell cycle progression of unperturbed cells. Therefore, it is plausible that treatment with a Chkl inhibitor alone could also be an efficacious cancer therapy. Here we report that Chk1-A, a potent and highly selective small molecule inhibitor of Chk1, is antiproliferative as a single agent in a variety of human cancer cell lines in vitro. The inhibition of proliferation is associated with collapse of DNA replication and apoptosis. Rapid decreases in inhibitory phosphorylation of CDKs and a concomitant increase in CDK kinase activity and chromatin loading of Cdc45 suggest that the antiproliferative and proapoptotic activity of Chk1-A is at least in part due to deregulation of DNA synthesis. We extend these in vitro studies by demonstrating that Chk1-A inhibits the growth of tumor xenografts in vivo in a treatment regimen that is well tolerated. Together, these results suggest that single-agent inhibition of Chk1 may be an effective treatment strategy for selected human malignancies.

The effects of L-theanine (Suntheanine®) on objective sleep quality in boys with attention deficit hyperactivity disorder (ADHD): a randomized, double-blind, placebo-controlled clinical trial.

INTRODUCTION: The purpose of this study was to investigate the efficacy and safety of L-theanine as an aid to the improvement of objectively measured sleep quality in a population of 98 male children formally diagnosed with attention-deficit/hyperactivity disorder (ADHD). METHODS: A randomized, double-blind, placebo-controlled trial was conducted involving boys, ages 8-12 years, who had been previously diagnosed with ADHD. An experienced physician confirmed the diagnosis of ADHD in each subject. Randomization was stratified based upon current use of stimulant medication to ensure an equal distribution of stimulant/non-stimulant treated subjects into active and placebo treated groups. Participants consumed two chewable tablets twice daily (at breakfast and after school), with each tablet containing 100 mg of L-theanine (total 400 mg daily Suntheanine®, Taiyo Kagaku, Yokkaichi, Japan) or identical tasting chewable placebo for six weeks. Subjects were evaluated for five consecutive nights using wrist actigraphy at baseline, and again at the end of the six-week treatment period. The Pediatric Sleep Questionnaire (PSQ) was completed by parents at baseline and at the end of the treatment period. RESULTS: Actigraph watch data findings indicated that boys who consumed L-theanine obtained significantly higher sleep percentage and sleep efficiency scores, along with a non-significant trend for less activity during sleep (defined as less time awake after sleep onset) compared to those in the placebo group. Sleep latency and other sleep parameters were unchanged. The PSQ data did not correlate significantly to the objective data gathered from actigraphy, suggesting that parents were not particularly aware of their children's sleep quality. L-theanine at relatively high doses was well tolerated with no significant adverse events. CONCLUSIONS: This study demonstrates that 400 mg daily of L-theanine is safe and effective in improving some aspects of sleep quality in boys diagnosed with ADHD. Since sleep problems are a common co-morbidity associated with ADHD, and because disturbed sleep may be linked etiologically to this disorder, L-theanine may represent a safe and important adjunctive therapy in childhood ADHD. Larger, long-term studies looking at the wider therapeutic role of this agent in this population are warranted.

Reduction of postprandial glycemia by the novel viscous polysaccharide PGX, in a dose-dependent manner, independent of food form.

OBJECTIVE: Health benefits of viscous fiber intake are well established; nevertheless few effective and palatable preparations are available. The objective of the study therefore was to determine palatability and effectiveness of escalating doses of PGX, a novel viscous polysaccharide (NVP), in reducing postprandial glycemia when added to a liquid and a solid meal. DESIGN: Two open-label, randomized, controlled trials were undertaken. SETTING: Glycemic Index Laboratories, Inc, Toronto, Ontario, Canada. SUBJECTS: Two groups of 10 healthy subjects each (group 1: 5 M, 5 F; 35.6 +/- 13.2 y; 24.6 +/- 2.1 kg/m(2); and group 2: 3 M, 7 F; 33.5 +/- 11.1 y; 26.3 +/- 5.2 kg/m(2)) were studied. INTERVENTIONS: Zero, 2.5, 5, and 7.5 g of NVP were added to a glucose drink (group 1) or to white bread and margarine (WB + Marg) (group 2). Subjects repeated glucose control (group 1) or WB control (group 2) 3 times to allow calculation of the glycemic index (GI). Measures of Outcomes: Palatability of foods and capillary blood glucose concentrations were measured fasting and at 15, 30, 45, 60, 90, and 120 minutes after the start of the meal. RESULTS: Addition of NVP to the meal reduced blood glucose incremental areas under the curve irrespective of dose, reaching significance at the 7.5 g dose when added to glucose (p < 0.01), and at the 5 and 7.5 g doses when added to WB + Marg (p < 0.001). The GI values of glucose with 0, 2.5, 5, or 7.5 g of NVP were (mean +/- standard error of the mean [SEM]) 100.0 +/- 0.0, 83.7 +/- 9.0, 77.7 +/- 8.2, and 72.5 +/- 5.9, respectively; the GI of the WB alone, or of WB + Marg, with 0, 2.5, 5, or 7.5 g of NVP was 71.0 +/- 0.0, 66.8 +/- 3.0, 47.5 +/- 5.9, 37.3 +/- 5.9, and 33.9 +/- 3.6, respectively. CONCLUSION: Addition of NVP to different food matrices is highly effective in lowering the glycemic index of a food in a dose-responsive manner.

The effect of a novel viscous polysaccharide along with lifestyle changes on short-term weight loss and associated risk factors in overweight and obese adults: an observational retrospective clinical program analysis.

BACKGROUND: Viscous soluble dietary fiber has been demonstrated to reduce postprandial glycemia and may promote satiety. PolyGlycopleX (PGX) is a highly viscous polysaccharide manufactured by reacting glucomannan with other soluble polysaccharides using a proprietary process (EnviroSimplex). The resulting polysaccharide (alpha-D-glucurono-alpha-D-manno-beta-D-manno-beta-D-glucan, alpha-L-gulurono-beta-D-mannuronan, beta-D-gluco-beta-D-mannan, alpha-D-glucurono-alpha-D-manno-beta-D-manno-beta-D-gluco, alpha-L-gulurono-beta-D-mannurono, beta-D-gluco-beta-D-mannan) is a novel entity with the highest viscosity and water-holding capacity of currently known fibers. MATERIALS AND METHODS: A total of 29 sedentary overweight or obese adults (23 women; six men), ages 20-65 with a body mass index (BMI) range of 25 kg/m(2) to 36 kg/m(2) participated in a clinical weight-loss program. PGX (5 g) was consumed with 500 mL water, 5-10 minutes before each meal, 2-3 times daily for 14 weeks. RESULTS: Significant reductions were observed (p less than 0.05) in weight (-5.79 +/- 3.55 kg), waist circumference (-12.07 +/- 5.56 cm), and percentage body fat (-2.43 +/- 2.39 percent) compared to baseline values. In addition, subjects employing PGX had a significant reduction of 19.26 percent (n=17; p less than 0.05) and 25.51 percent (n=16; p less than 0.05) in total and LDL plasma cholesterol values, respectively, at the end of the study period. CONCLUSION: The consumption of PGX in concert with lifestyle modifications may be a useful strategy for weight loss in overweight and obese individuals.

Effect of adding the novel fiber, PGX®, to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial.

BACKGROUND: Reductions in postprandial glycemia have been demonstrated previously with the addition of the novel viscous polysaccharide (NVP), PolyGlycopleX® (PGX®), to an OGTT or white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods or incorporated into a breakfast cereal. METHODS: Ten healthy subjects (4M, 6F; age 37.3 ± 3.6 y; BMI 23.8 ± 1.3 kg/m2), participated in an acute, randomized controlled trial. The glycemic response to cornflakes, rice, yogurt, and a frozen dinner with and without 5 g of NVP sprinkled onto the food was determined. In addition, 3 granolas with different levels of NVP and 3 control white breads and one white bread and milk were also consumed. All meals contained 50 g of available carbohydrate. Capillary blood samples were taken fasting and at 15, 30, 45, 60, 90 and 120 min after the start of the meal. The glycemic index (GI) and the glycemic reduction index potential (GRIP) were calculated. The blood glucose concentrations at each time and the iAUC values were subjected to repeated-measures analysis of variance (ANOVA) examining for the effect of test meal. After demonstration of significant heterogeneity, differences between individual means was assessed using GLM ANOVA with Tukey test to adjust for multiple comparisons. RESULTS: Addition of NVP reduced blood glucose response irrespective of food or dose (p < 0.01). The GI of cornflakes, cornflakes+NVP, rice, rice+NVP, yogurt, yogurt+NVP, turkey dinner, and turkey dinner+NVP were 83 ± 8, 58 ± 7, 82 ± 8, 45 ± 4, 44 ± 4, 38 ± 3, 55 ± 5 and 41 ± 4, respectively. The GI of the control granola, and granolas with 2.5 and 5 g of NVP were 64 ± 6, 33 ± 5, and 22 ± 3 respectively. GRIP was 6.8 ± 0.9 units per/g of NVP. CONCLUSION: Sprinkling or incorporation of NVP into a variety of different foods is highly effective in reducing postprandial glycemia and lowering the GI of a food. CLINICAL TRIAL REGISTRATION: NCT00935350.

Laboratory methods supporting measles surveillance in Queensland, Australia, 2010-2017.

PURPOSE: Australia was officially recognised as having eliminated endemic measles transmission in 2014. Maintaining laboratory support for surveillance of vaccine-preventable diseases, such as measles, is an essential component of reaching and maintaining transmission-free status. METHODOLOGY: Real-time and conventional PCR-based tools were used to detect, differentiate from measles vaccine virus (MeVV), and sequence fragments of measles viruses (MeV) identified from specimens collected in Queensland. Specimens were mostly from travellers who had visited or returned to Queensland from international or interstate sites or been in contact with a case from either group. RESULTS: Between 2010 and 2017, 13 678 specimens were tested in our laboratory using real-time RT-PCR (RT-rPCR), identifying 533 positives. Most specimens were swabs (70.98 %) and urines (25.56 %). A MeVV RT-rPCR was used on request and identified 154 instances of MeVV. MeV-positive extracts were genotyped as required. Genotypes identified among sequenced specimens included B3, D4, D8, D9, G3, and H1 as well as members of clade A as expected from the detection of MeV among virus introductions due to global travel and vaccination. CONCLUSION: We describe the workflow employed and results from our laboratory between 2010 and 2017 for the sensitive detection of MeV infection, supporting high-quality surveillance to ensure the maintenance of Australia's measles-free status.

Detection of human bocavirus in respiratory, fecal, and blood samples by real-time PCR.

Human bocavirus (HBoV) has been detected worldwide in respiratory samples. Two real-time PCR assays, targeting the non-structural protein (NP-1) and viral protein (VP-1) genes, were designed and validated to detect HBoV in patients with respiratory disease, gastroenteritis, or systemic illness. Sensitivity of the NP-1 and VP-1 assays were equal to the conventional PCR assay previously described by Allander et al. [2005: Proc Natl Acad Sci USA 102: 12891-12896] being 100%, and giving specificity of 94% and 93%, respectively. There was no cross-reaction identified with unrelated respiratory agents, or to human DNA. The limits of detection were 10 copies of genomic DNA equivalents per reaction for both assays. The assays were used to screen three different sample populations, combined nose, and throat swabs (n = 96) from children with acute respiratory disease, fecal samples (n = 375) from adults, and children with gastroenteritis and whole blood (n = 229) collected from 31 immunocompromised children taken over an 18-month period. In total 17 (18%) respiratory samples and 18 (4.8%) fecal samples were identified as having HBoV present. Of the pediatric whole blood specimens investigated, HBoV was detected in six (2.6%) samples from four patients. In summary, two real-time PCR assays targeting different genes were designed and validated for use as screening methods for the detection of HBoV. HBoV was found in three different specimen types: parent-collected combined nose-throat swabs, fecal samples collected from symptomatic individuals and whole blood from immunocompromised children.

The safety of PolyGlycopleX (PGX) as shown in a 90-day rodent feeding study.

BACKGROUND: This study was designed to evaluate the safety of PolyGlycopleX (PGX), a novel viscous dietary polysaccharide (fiber), when administered to Sprague Dawley(R) rats in the diet for 90 days. METHODS: Groups of ten male and ten female rats each consumed PGX mixed in the diet at levels of 0, 1.25, 2.5 or 5.0% for 90 days, then evaluated for toxicological effects on parameters that included neuromotor activity, body weight, clinical chemistry, urinalysis, hematology, and histopathology. RESULTS: Mean body weight, mean feed consumption and food efficiency in the treated groups were generally comparable to controls for both male and female rats. No changes were noted in neuromotor behavior, and histopathological analysis revealed no significant changes between treated and control animals. There were no differences in mean organ weight, organ-to-body weight or organ-to-brain weight values between controls and treated animals. Decreased red blood cell count occurred in the high dose males and increases in aspartate and alanine aminotransferase enzyme levels and triglycerides, while significant decreases in serum sodium, potassium and chloride concentrations were observed in the females fed 5.0% PGX. However, the decreased mineral concentrations may be the result of significantly increased urinary volume in both males and females at the high dose, with a concomitant decrease in urinary specific gravity (males and females) and protein concentration (females). These results were within historical control values, did not correlate with any histopathological changes, and were not considered adverse. CONCLUSION: The results indicate a no observed adverse effect level (NOAEL) for PGX at 5.0% of the diet, corresponding to an average daily intake of 3219 and 3799 mg/kg bw/day in male and female rats, respectively.

Supplementation of the diet with the functional fiber PolyGlycoplex is well tolerated by healthy subjects in a clinical trial.

BACKGROUND: The relationship of dietary fiber to overall health is of great importance, as beneficial effects have been demonstrated with the use of fiber from diverse sources, some traditional, other novel. PolyGlycopleX (PGX) is a unique proprietary product composed of three water-soluble polysaccharides, that when processed using novel technology give rise to a final product - a soluble, highly viscous functional fiber. METHODS: Because of its potential use in food and dietary supplements, a randomized, double-blind, placebo controlled clinical study was conducted to evaluate the tolerance to PGX ingestion for 21 days, to a maximum dose level of 10 g per day, in healthy male and female volunteers. The main objective of the study was to evaluate the overall gastrointestinal (GI) tolerance, while secondary objectives were to evaluate possible changes in hematological, biochemical, urinary and fecal parameters. RESULTS: Results show that PGX is well tolerated as part of a regular diet with only mild to moderate adverse effects, similar to those seen with a moderate intake of dietary fiber in general, and fruits and vegetables. Because PGX is a highly viscous, functional fiber, it also demonstrates several physiological responses including, but not limited to maintaining healthy total and LDL cholesterol and uric acid levels.

Genotoxicity studies of PolyGlycopleX (PGX): a novel dietary fiber.

PolyGlycopleX (PGX), a novel dietary fiber, produces no mutagenic effects in bacterial tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, and TA 1537 and Escherichia coli WP2 uvrA at concentrations of 0.316, 1.00, 3.16, 10.0, 31.6, and 100 microg/plate. No biologically relevant increases in revertant colonies of any of the 5 strains are observed at any concentration; however, a reduction at 100 microg/plate in TA 1537 is noted. PGX, analyzed for polychromatic erythrocyte micronuclei induction in mice following a single 1x, 0.5x, and 0.2x maximum tolerable dose intraperitoneal treatment, produces no biologically relevant increase in any dose group. Males at 1x maximum tolerable dose show a reduction of micronuclei-containing cells. High-dose animals show signs of systemic toxicity, including a reduction of spontaneous activity, rough fur, palpebral closure, prone position, and constricted abdomen. These genotoxicity studies show PGX to be nonmutagenic in both the Ames bacterial reverse mutation assay and the mammalian erythrocyte micronucleus test.

Epidemics of gastroenteritis during 2006 were associated with the spread of norovirus GII.4 variants 2006a and 2006b.

BACKGROUND: Acute gastroenteritis is commonly associated with norovirus genogroup II (GII) infection. Norovirus GII has 17 classified genotypes (GII.1-GII.17), but only 1 norovirus genotype (GII.4) is associated with global epidemics of gastroenteritis. In 2006, an increase in global norovirus activity was observed. METHODS: During the period from December 2005 through August 2006, a total of 231 fecal samples were obtained from patients with acute gastroenteritis from Australia and New Zealand. Norovirus RNA was amplified and sequenced to determine norovirus genotype and relatedness to known epidemic norovirus GII.4 variants. RESULTS: Two GII.4 variants, designated 2006a and 2006b, were identified in 61.8% and 11.3%, respectively, of the 186 cases investigated. Norovirus 2006a and 2006b have also been implicated as the predominant causes of norovirus-associated gastroenteritis across Europe in 2006. CONCLUSIONS: The global increase in norovirus-associated gastroenteritis in 2006 was linked to the emergence of 2 novel GII.4 variants, 2006a and 2006b.

Connexins within the rat larynx.

OBJECTIVES/HYPOTHESIS: To determine the types and localization of connexins within the rat larynx. STUDY DESIGN: Quantitative real time polymerase chain reaction (qRT-PCR) of the epiglottis and laryngeal mucosa was used to identify connexins (Cx). Immunohistochemical labeling was then used to localize the Cxs within the larynx. METHODS: Twelve larynges from 3 to 4 month old Fisher-344 rats were used. RNA was extracted (N = 8) and cDNA produced. Primers for Cx26, Cx30, Cx32, Cx37, Cx40, and Cx43 were added and qRT-PCR performed. Others larynges were serially sectioned for immunohistochemistry. RESULTS: qRT-PCR revealed Cx43, Cx32, and Cx30 within the epiglottis and Cx43 in the vocal folds and Cx43 and Cx32 within the subglottic mucosa. Immunohistochemical staining confirmed these results. CONCLUSION: The rat epiglottis is rich in Cx43, Cx32, and Cx30 whereas the vocal folds contain Cx43 and the subglottic mucosa Cx43 and Cx32. Their localizations suggest involvement in secretion for protective purposes and they may play a key role in laryngeal pathoses.