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Bloomington, IN, United States

Brouns F.,Maastricht University | Theuwissen E.,Maastricht University | Adam A.,Cargill Inc. | Bell M.,ClinData Services Inc. | And 2 more authors.
European Journal of Clinical Nutrition | Year: 2012

Background/Objectives:Viscous fibers typically reduce total cholesterol (TC) by 3-7% in humans. The cholesterol-lowering properties of the viscous fiber pectin may depend on its physico-chemical properties (viscosity, molecular weight (MW) and degree of esterification (DE)), but these are not typically described in publications, nor required by European Food Safety Authority (EFSA) with respect to its generic pectin cholesterol-lowering claim.Subjects/Methods: Here, different sources and types of well-characterized pectin were evaluated in humans. Cross-over studies were completed in mildly hyper-cholesterolemic persons receiving either 15 g/day pectin or cellulose with food for 4 weeks.Results:Relative low-density lipoprotein (LDL) cholesterol (LDL-C) lowering was as follows: citrus pectin DE-70apple pectin DE-70 (7-10% reduction versus control)>apple pectin DE-35=citrus pectin DE-35>OPF (orange pulp fiber) DE-70 and low-MW pectin DE-70>citrus DE-0. In a subsequent 3-week trial with 6 g/day pectin, citrus DE-70 and high MW pectin DE-70 reduced LDL-C 6-7% versus control (without changes in TC). In both studies, high DE and high MW were important for cholesterol lowering. Source may also be important as citrus and apple DE-70 pectin were more effective than OPF DE-70 pectin. Pectin did not affect inflammatory markers high-sensitivity C-reactive protein (hsCRP) nor plasma homocysteine.Conclusions:Pectin source and type (DE and MW) affect cholesterol lowering. The EFSA pectin cholesterol-lowering claim should require a minimum level of characterization, including DE and MW. © 2012 Macmillan Publishers Limited All rights reserved. Source


Rausch-Derra L.C.,Aratana Therapeutics | Huebner M.,ClinData Services Inc. | Rhodes L.,Aratana Therapeutics
American Journal of Veterinary Research | Year: 2015

OBJECTIVE To investigate the safety of daily oral administration of grapiprant to dogs. ANIMALS Thirty-six 9-month-old Beagles of both sexes. PROCEDURES Dogs were randomly assigned to groups that received grapiprant via oral gavage at 0, 1, 6, or 50 mg/kg (total volume, 5 mL/kg), q 24 h for 9 months. Each group contained 4 dogs of each sex (ie, 8 dogs/group), except for the 50 mg/kg group, which included 4 additional dogs that were monitored for an additional 30 days after treatment concluded (recovery period). All dogs received ophthalmologic, ECG, and laboratory evaluations before treatment began (baseline) and periodi- cally afterward. All dogs were observed daily. Dogs were euthanized at the end of the study for necropsy and histologic evaluation. RESULTS All dogs remained clinically normal during treatment, with no apparent chang- es in appetite or demeanor. Emesis and soft or mucoid feces that occasionally contained blood were observed in all groups, although these findings were more common in dogs that received grapiprant. In general, clinicopathologic findings remained within baseline ranges. Drug-related changes in serum to- tal protein and albumin concentrations were detected, but differences were small and resolved during recovery. No drug-related gross or microscopic pathological changes were detected in tissue samples except mild mucosal regeneration in the ileum of 1 dog in the 50 mg/kg group. CONCLUSIONS AND CLINICAL RELEVANCE Results suggested the safety of long-term oral administration of grapiprant to dogs. Efficacy of grapiprant in the treatment of dogs with osteoarthritis needs to be evaluated in other studies. © 2015, American Veterinary Medical Association. All rights reserved. Source


Dammann K.W.,Cargill Inc. | Bell M.,ClinData Services Inc. | Kanter M.,Excelsior | Berger A.,Cargill Inc. | Berger A.,University of Minnesota
Nutritional Neuroscience | Year: 2013

Objectives: To evaluate whether consumption of the low-glycemic index (GI) carbohydrate sucromalt improves healthy adults' perceptions of mental and physical energy and fatigue compared to dextrose (glucose), a high GI control. Methods: In this double-blind, randomized, cross-over study, subjects (n = 44 healthy adults) consumed a standardized dinner, and following an overnight fast, ingested 75 g of either sucromalt or glucose in solution at 7:30 AM the next day. Subjects completed validated questionnaires that assessed mental and physical energy, and fatigue, hunger, and sleepiness at baseline and hourly until 12:30 PM for a total of five post-consumption time points. Within-subject differences adjusted for baseline for individual questions and composite scores (Mental Energy State, Mental Fatigue State, Physical Energy State, and Physical Fatigue State) were analyzed using repeated measures analysis of variance. Results: Mental Energy State, Physical Energy State, and Physical Fatigue State results favored sucromalt compared to glucose, with significant differences emerging particularly after 4-5 hours (P < 0.050). A trend toward a delay in Mental Fatigue State was also observed with sucromalt compared to glucose (P < 0.100). Minimal differences in ratings of hunger and sleepiness were observed between the beverages. Discussion: Sucromalt may help attenuate the perceived decline in mental and physical energy and rise in mental and physical fatigue that can occur 4-5 hours after ingestion of a high GI beverage. Trials examining effects of sucromalt on cognitive and physical performance are of future interest. © W. S. Maney & Son Ltd 2013. Source


Maki K.C.,Provident Clinical Research | Rains T.M.,Provident Clinical Research | Dicklin M.R.,Provident Clinical Research | Bell M.,ClinData Services Inc.
Diabetes Technology and Therapeutics | Year: 2010

Background: The objective of this investigation was to evaluate the test-retest repeatability of insulin sensitivity and secretion indices derived from liquid meal tolerance tests (MTTs) in subjects with normal fasting glucose (NFG) (n=20), impaired fasting glucose (IFG) (n=20), or type 2 diabetes mellitus (n=38). Methods: The Matsuda Index of insulin sensitivity and a Disposition Index (the product of the Matsuda Index and the ratio of the total areas under the curves for glucose and insulin from 0 to 120min) were assessed in two standard liquid MTTs, separated by approximately 1 week. Results: Mean±SD Matsuda Index values were 14.2±7.6, 8.8±4.7, and 6.3±4.0, and Disposition Index values were 1,009.6±355.5, 671.4±249.0, and 201.8±101.3 for NFG, IFG, and diabetes, respectively (all P<0.05 except Matsuda Index for IFG vs. diabetes, P=0.241). Differences between tests in subjects with NFG, IFG, and diabetes, respectively, were-0.2±3.6 (coefficient of variation for the method error, 17.9%), 0.2±3.2 (26.1%), and 0.1±3.0 (34.1%) for the Matsuda Index and 16.5±225.8 (16.1%), 13.3±221.6 (23.1%), and 15.2±79.4 (28.1%) for the Disposition Index. Conclusions: The Matsuda and Disposition indices derived from liquid MTTs appropriately ranked categories of fasting glucose tolerance and have repeatability profiles suggesting potential usefulness in population studies and moderately sized clinical trials requiring repeated measurements. © Copyright 2010, Mary Ann Liebert, Inc. Source


Maki K.C.,Midwest Center for Metabolic and Cardiovascular Research | Geohas J.G.,Evanston Premier Healthcare Research | Dicklin M.R.,Midwest Center for Metabolic and Cardiovascular Research | Huebner M.,ClinData Services Inc. | Udani J.K.,Medicus Research LLC
Prostaglandins Leukotrienes and Essential Fatty Acids | Year: 2015

This randomized, double-blind, placebo-controlled multi-center trial investigated the lipid-altering effects of a medical food (PDL-0101) providing 1.8. g/d eicosapentaenoic acid; 12. mg/d astaxanthin, a marine algae-derived carotenoid; and 100. mg/d tocopherol-free gamma/delta tocotrienols enriched with geranylgeraniol, extracted from annatto, on triacylglycerols (TAG), other lipoprotein lipids, and oxidized low-density lipoprotein (LDL) in 102 subjects with TAG 150-499. mg/dL (1.69-5.63. mmol/L) and LDL cholesterol (LDL-C) ≥70. mg/dL (1.81. mmol/L). Compared to placebo, after eight weeks of treatment, PDL-0101 significantly reduced median TAG (-9.5% vs. 10.6%, p<0.001), while not significantly altering mean LDL-C (-3.0% vs. -8.0% for PDL-0101 and placebo, respectively, p=0.071), mean high-density lipoprotein cholesterol (~3% decrease in both groups, p=0.732), or median oxidized LDL concentrations (5% vs. -5% for PDL-0101 and placebo, respectively, p=0.112). These results demonstrate that PDL-0101 is an effective medical food for the management of elevated TAG. © 2015 Elsevier Ltd. Source

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