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Reimer R.A.,University of Calgary | Pelletier X.,Optimed Clinical Research | Carabin I.G.,Burdock Group | Lyon M.,Canadian Center for Functional Medicine | And 4 more authors.
European Journal of Clinical Nutrition | Year: 2010

Background/Objectives:A variety of dietary fibers have been shown to alter satiety hormone gene expression and secretion. The objective of this study was to examine plasma satiety hormone concentrations in healthy subjects consuming either PolyGlycopleX (PGX) or control (skim milk powder) for 21 days.Subjects/Methods:A randomized, double-blind, placebo-controlled clinical study was conducted in 54 healthy male and female adults. Participants consumed 5 g per day of PGX or control for 1 week followed by 2 additional weeks of 10 g per day of assigned product (n27 per group). Primary outcomes measured at three visits (V1, V2 and V3) were plasma active glucagon-like peptide-1 (GLP-1) total ghrelin, peptide YY (PYY) and insulin.Results:There was a significant effect of visit for fasting PYY with control participants experiencing decreased PYY levels over time while PGX prevented this decline. When stratified by body mass index (BMI), PGX increased fasting PYY levels from week 1 to week 3 compared with control in participants with BMI <23 kg/m2. There was a significant effect of visit for fasting ghrelin with levels decreasing in both PGX and control groups over time. No differences were detected in fasting GLP-1 levels. Although there was a 14% reduction in fasting insulin between V1 and V3 with PGX this was not significantly different from control.Conclusions:PGX is a highly viscous, functional fiber that modifies satiety hormone secretion in healthy adults. Its potential to act similarly in overweight adults warrants investigation. © 2010 Macmillan Publishers Limited All rights reserved.

Szabo N.J.,Burdock Group
Food and Chemical Toxicology | Year: 2014

Extracts, teas, and other preparations of Astragalus roots (e.g., Radix Astragali) are historically recognized traditional medicines and foods. Cycloastragenol (CAG), a bioactive triterpene aglycone from Astragalus root extracts, is being developed as a modern dietary ingredient. To this end, studies assessing subchronic toxicity and genotoxic potential were conducted. In the subchronic study with recovery component, rats ingested 0, 40, 80, or 150. mg/kg/d CAG by oral gavage for ≥91 consecutive days. No treatment-related mortalities occurred and no cardiac effects were identified. Although several endpoints among those monitored (i.e., clinical observations, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, gross pathology, organ weights, or histopathology) exhibited statistically significant effects, none was adverse. The oral no-observed-adverse-effect level (NOAEL) for CAG was >150. mg/kg/d in male and female rats. CAG (≤5000. μg/plate) did not induce mutagenicity in Salmonella typhimurium or Escherichia coli tester strains. Although the in vitro chromosome aberration assay gave a moderately positive response (likely due to poor solubility) for one intermediate concentration (1.50. mM) with metabolic activation, responses were negative in all other test groups. Finally, in the in vivo micronucleus assay no clastogenicity was observed in peripheral erythrocytes from mice administered 2000. mg/kg CAG by intraperitoneal injection. © 2013 Elsevier Ltd.

Dolan L.C.,Burdock Group | Chaumont V.,Regulations
Agro Food Industry Hi-Tech | Year: 2011

Ideally, the same product claim for dietary supplement ingredients in the USA could be used internationally. However, based on the different manner in which supplement ingredients are regulated in the USA and Europe, many claims that are permitted in the USA are not in Europe (or vice versa). In general, it is believed that it is more difficult to market products with claims in Europe because, unlike in the USA, all claims in Europe must have pre-market approval by the European Food Safety Agency (EFSA) and member states of the European Commission. On balance however, for some dietary ingredients, the Europeans have allowed more compelling or specific claims than permitted in the USA. This article highlights the similarities and differences between the USA and European perspective, employing a case-study of claims permitted for calcium and omega-3-fatty acids.

Kagan M.L.,Qualitas Health Ltd. | Matulka R.A.,Burdock Group
Toxicology Reports | Year: 2015

Nannochloropsis oculata is a marine-water microalgae that is considered to be a good source of omega-3 fatty acids, specifically eicosapentaenoic acid (EPA), utilized in the production of an omega-3 oil for use as a dietary supplement. This study investigates the safety of N. oculata in male and female Sprague-Dawley rats administered a 0 or 10. mL/kg bw/rat N. oculata (10E8 viable cells/mL) suspension by oral gavage once daily for 14 consecutive days. No mortalities occurred and no signs of toxicity were observed during the study. No treatment-related effects were seen for body weight, food consumption, urinalysis, clinical chemistry, hematology, gross pathology, organ weights, or histopathology. Although statistically significant effects were noted for some endpoints, none were considered to be of toxicological significance. The N. oculata suspension was concluded to have no toxicity in rats, confirming that the algal strain used in the production of omega-3 oil is not pathogenic when administered orally to rats. © 2015 The Authors.

Szabo N.J.,Burdock Group | Matulka R.A.,Burdock Group | Chan T.,Solazyme
Food and Chemical Toxicology | Year: 2013

Microalgae such as Chlorella spp., were once consumed as traditional human foods; now they are being developed as ingredients for modern diets. Whole Algalin Protein (WAP) from dried milled Chlorella protothecoides was evaluated for dietary safety in a 13-week feeding trial in rodents with genotoxic potential evaluated using in vitro and in vivo assays and the likelihood of food allergy potential evaluated via human repeat-insult patch test (HRIPT). In the subchronic study, rats consumed feed containing 0, 25,000, 50,000 or 100,000. ppm WAP for 92-93. days. No treatment-related mortalities or effects in general condition, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, gross pathology, organ weights, and histopathology occurred. Several endpoints exhibited statistically significant effects, but none was dose-related. The no-observed-adverse-effect level (NOAEL) was based on the highest WAP concentration consumed by the rats and was equivalent to 4805. mg/kg/day in males and 5518. mg/kg/day in females. No mutagenicity occurred in Salmonella typhimurium or Escherichia coli tester strains (≤5000. μg/plate WAP) with or without mutagenic activation. No clastogenic response occurred in bone marrow from mice administered a single oral dose (2000. mg/kg WAP). Skin sensitization was not induced by WAP via HRIPT, indicating little potential for food allergy. © 2013 Elsevier Ltd.

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