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LeBeau A.,Burdock Group | Matulka R.,Burdock Group | Comstock B.,Tamarak Biotics
Food and Chemical Toxicology | Year: 2017

TruActive™ NF is a novel, fat-free, milk-based protein powder to be added to food to increase protein content and is manufactured using non-thermal treatment to reduce potential pathogens most relevant to protecting public health. TruActive™ NF was evaluated for potential pathogens of concern to public health regulators; none were detected. The estimated daily intake (EDI) of TruActive™ NF at a 90th percentile consumption for the powder in nutritional beverages and bars is 14,700 mg/day. In vitro genotoxicity testing revealed that concentrations of TruActive™ NF up to 5000 μg/plate did not induce point mutations in selected strains. Oral administration of TruActive™ NF to male Sprague-Dawley rats in an in vivo mammalian chromosomal aberration assay did not induce chromosomal aberrations or significantly affect mitosis in bone marrow cells at 2000 mg/kg. Male and female Sprague-Dawley rats were administered TruActive™ NF at concentrations of 7.5%, 15%, and 30% of the diet during a 28-day subacute dietary study followed by a 14-day recovery period. Some parameters were altered at the 30% diet concentration. The No Observed Adverse Effect Level (NOAEL) in the 28-day dietary study was at 15% of the diet (11,812 mg/kg bw/day for male rats and 11,521 mg/kg bw/day for female rats). © 2017 Elsevier Ltd


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.


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.


Dolan L.C.,Burdock Group | Potter S.M.,Burdock Group | Burdock G.A.,Burdock Group
Critical reviews in food science and nutrition | Year: 2010

In recent years, there has been episodic speculation that an increase in consumption of fructose from foods and beverages is an underlying factor responsible for the relatively recent increase in obesity and obesity-related diseases such as diabetes. Reports in support of this hypothesis have been published, showing that concentrations of triglycerides (TG) are higher and concentrations of insulin and hormones associated with satiety are lower in animals following the ingestion of fairly large quantities of fructose, compared to other carbohydrates. However, results from human studies are inconsistent. A possible reason for the inconsistent results is that they are dependent on the particular study population, the design of the studies, and/or the amount of fructose administered. A systematic assessment of the strength and quality of the studies and their relevance for healthy, normal weight humans ingesting fructose in a normal dietary manner has not been performed. The purpose of this review was to critically evaluate the existing database for a causal relationship between the ingestion of fructose in a normal, dietary manner and the development of hyperlipidemia or increased body weight in healthy, normal weight humans, using an evidence-based approach. The results of the analysis indicate that fructose does not cause biologically relevant changes in TG or body weight when consumed at levels approaching 95th percentile estimates of intake.


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 | Potter S.M.,Tate and Lyle Health and Nutrition science | Burdock G.A.,Burdock Group
Critical Reviews in Food Science and Nutrition | Year: 2010

Although some investigators have hypothesized that ingestion of fructose from foods and beverages is responsible for the development of hyperlipidemia or obesity, a recent evidence-based review demonstrated that there was no relationship between the consumption of fructose in a normal dietary manner and the development of hyperlipidemia or increased weight in normal weight individuals. Because overweight and obese individuals may exhibit metabolic abnormalities such as insulin resistance, impaired glucose tolerance, hyperlipedemia, and/or alterations in gut hormones involved in appetite regulation, the findings of fructose studies performed in normal weight subjects may not be particularly relevant for overweight or obese subjects. A systematic assessment of the strength and quality of the studies and their relevance for overweight or obese humans ingesting fructose in a normal dietary manner has not been performed. The purpose of this review was to critically evaluate the existing database for a causal relationship between the ingestion of fructose in a normal, dietary manner and the development of hyperlipidemia or increased body weight in overweight or obese humans, using an evidence-based approach. The results of the analysis indicate that there is no evidence which shows that the consumption of fructose at normal levels of intake causes biologically relevant changes in triglycerides (TG) or body weight in overweight or obese individuals. © 2010 Burdock Group Consultants.


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.


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.


Dolan L.C.,Burdock Group | Matulka R.A.,Burdock Group | Burdock G.A.,Burdock Group
Toxins | Year: 2010

Although many foods contain toxins as a naturally-occurring constituent or, are formed as the result of handling or processing, the incidence of adverse reactions to food is relatively low. The low incidence of adverse effects is the result of some pragmatic solutions by the US Food and Drug Administration (FDA) and other regulatory agencies through the creative use of specifications, action levels, tolerances, warning labels and prohibitions. Manufacturers have also played a role by setting limits on certain substances and developing mitigation procedures for process-induced toxins. Regardless of measures taken by regulators and food producers to protect consumers from natural food toxins, consumption of small levels of these materials is unavoidable. Although the risk for toxicity due to consumption of food toxins is fairly low, there is always the possibility of toxicity due to contamination, overconsumption, allergy or an unpredictable idiosyncratic response. The purpose of this review is to provide a toxicological and regulatory overview of some of the toxins present in some commonly consumed foods, and where possible, discuss the steps that have been taken to reduce consumer exposure, many of which are possible because of the unique process of food regulation in the United States. © 2010 by the authors. licensee MDPI, Basel, Switzerland.


Szabo N.J.,Burdock Group | Matulka R.A.,Burdock Group | Kiss L.,Solazyme | Licari P.,Solazyme
Regulatory Toxicology and Pharmacology | Year: 2012

Microalgae such as Chlorella spp. have a long history of use in human food. A high lipid Whole Algalin Flour (WAF) composed of dried milled Chlorella protothecoides was evaluated for subchronic toxicity and genotoxic potential. Likelihood of food allergy potential was also evaluated by human repeat-insult patch test. In the subchronic study, rats were fed dietary levels of 25,000, 50,000 or 100,000. ppm WAF in feed for 93-94. days. No mortalities occurred. No treatment-related effects were identified for general condition, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, gross pathology, organ weights, and histopathology. Although statistically significant effects were noted for several endpoints, none was test-substance related. The no-observed-adverse-effect level (NOAEL) for WAF was based on consumption of the 100,000. ppm diet, the highest dietary concentration tested, and was 4807. mg/kg bw/d in male rats and 5366. mg/kg bw/d in female rats. Additionally, WAF (≤5000 μg/plate) was not mutagenic in Salmonella typhimurium or Escherichia coli tester strains nor did WAF induce a clastogenic response in bone marrow from mice given a single oral dose (2000. mg/kg bw). Further, WAF did not elicit skin sensitization in a repeat-insult dermal patch test which indicates little potential for food allergy. © 2012 Elsevier Inc.

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