Ray Matulka

Soy leghemoglobin (LegH) protein derived from soy (Glycine max) produced in Pichia pastoris (reclassified as Komagataella phaffii) as LegH Prep is a novel food ingredient that provides meat-like flavor and aroma to plant-derived food products. The safety of LegH Prep has been previously assessed in a battery of in vivo and in vitro testing and foun...

Edible Pongamia Oil (EPO) was evaluated in an acute oral toxicity study, GLP 14-Day and 90-Day repeated dose isocaloric dietary toxicity studies in rats, and in vitro Bacterial Reverse Mutation, and in vivo Mammalian Bone Marrow Chromosome Aberration genotoxicity studies for potential use as a food ingredient. In a non-GLP acute study, an LD50 > 50...

In the food industry, most fatty acid-rich oils are primarily composed of saturated even-chain fatty acids. However, saturated odd-chain fatty acids are potentially a beneficial alternative to other saturated fatty acid-containing oils. In this communication, we examine the safety of odd-chain fatty acid (OCFA) algal oil, a microalgal-sourced oil c...

Chickens exposed to antigens produce IgY antibodies, similar in structure to mammalian IgG. Hens exposed with an allergen produced by cats (Fel d 1) results in production of anti-Fel d 1 specific IgY (AFD1), which is naturally concentrated in egg yolk. A chicken egg product ingredient containing AFD1 was evaluated for safety in a 26-week randomized...

A variety of different substances can promote adverse effects on livestock and companion animals, varying from a decrease in overall growth, to frank toxicological response and death. Many substances that are the cause of adverse effects are either components in feed, part of the forage landscape for grazing animals, or even a part of the nutritive...

Consumers are looking for minimally processed foods and prefer foods that contain little or no 'synthetic’ ingredients, as ‘natural’ ingredients carry the perception of inherent safety. Food manufacturers are responding by developing new and expanded uses of traditional food ingredients that are typically considered ‘natural’ by the consumer, at le...

Consumers are demanding plant-based alternative protein sources to complement traditional animal-based protein sources to fulfill their dietary protein requirements. KALGAE™, a dried algal biomass derived from Klebsormidium flaccidum var. ZIVO, is a potential source of plant-based protein that has been evaluated for safety to support its use as a f...

The aim of this study was to assess the effects of Sangrovit®, a standardized preparation of Macleaya cordata extract (MCE), on the health status and retained residues in growing-finishing swine. A total of twelve growing-finishing swine (n = 6 for each group) were randomly divided into two groups and fed either a control feed or the control feed s...

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 est...

Two new strains of Sphingomonas elodea (designated as PHP1 and PBAD1) were tested for toxicity and pathogenicity in healthy Sprague-Dawley CD(®) IGS rats in separate studies. In each study, twelve rats/sex were administered ≥10(8) viable cells/rat by oral gavage, and four untreated rats/sex served as controls. Blood, feces, and selected organs/tiss...

Microalgae are increasingly being utilized as food ingredients for a variety of applications, including as sources of protein, egg and dairy substitutes, and cooking oils. The dietary safety of a new structuring fat produced using a heterotrophic fermentation process by a strain of Prototheca moriformis was evaluated in a 13-week dietary toxicity s...

Use of pecan shell fiber in human food is presently limited, but could increase pending demonstration of safety. In a 91-day rat study, pecan shell fiber was administered at dietary concentrations of 0 (control), 50 000, 100 000 or 150 000ppm. There was no effect of the ingredient on body weight of males or females or food consumption of females. S...

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/...

Probiotics have been consumed for centuries as part of food with known beneficial effects on the body. Today, more people are turning to natural products to maintain health, as well as potentially prevent diseases or their symptoms. Recent scientific studies find benefits on unlikely organ systems, and so companies are utilizing this information to...

Lacprodan(®) OPN-10 is a proprietary whey-based protein product that contains bovine-derived osteopontin (OPN), found in human milk and other bodily tissues. In vitro genotoxicity tests conducted according to accepted guidelines at up to 5000 μg/plate OPN failed to induce genetic mutations in Salmonella typhimurium strains and Escherichia coli stra...

Feed palatability is necessary for optimum feed intake and utilization in all animal species. The effects of consumption of a standardized preparation of an extract of Macleaya cordata (M. cordata), a herbaceous flowering perennial of the Papaveraceae family that contains isoquinoline alkaloids, has been evaluated when fed to chickens for 35 consec...

Numbers of macro- and microalgae have been used as food sources in various cultures for centuries. Several microalgae are currently being developed as modern food ingredients. The dietary safety of oleic-rich microalgal oil produced using a heterotrophic fermentation process was assessed in a 13-week feeding trial in rats with genotoxic potential e...

Sales and use of dietary supplements in the United States is ever growing, as consumers are supplementing the diet with products that benefit health and performance. The US Congress enacted DSHEA in 1994 to better regulate the safety of dietary supplements. Dietary ingredients that had not been consumed prior to October 15, 1994 must be notified to...

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 as...

Fibermalt is a new soluble fiber food ingredient produced with the use of an alternansucrase enzyme from Leuconostoc mesenteroides expressed in a non-pathogenic strain of Escherichia coli. Fibermalt is predominantly composed of indigestible maltose alternan oligosaccharides (≥ 80%). Fibermalt was non-mutagenic in a bacterial reverse mutation test....

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 w...

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 throug...

The aloe vera plant has a long history of safe use for oral and topical applications. This publication describes safety studies conducted on a proprietary high-purity aloe vera inner leaf fillet preparation, Qmatrix. In a 13-week study in rats, Qmatrix was administered via gavage at 0, 500, 1000 and 2000 mg/kg body weight (bw)/day. There were no si...

Incorporation of a new flavour ingredient into a product can be a costly endeavour if it is not already approved for use, but because of the unique US system of multiple routes for ingredient approval, how can a manufacturer ensure the flavour ingredient is approved and for what uses? This manuscript addresses three principal sources for determinin...

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. 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...

Consumption of the isoflavones daidzein, genistein, glycitein, and their structural analogues is generally considered beneficial to human health. Equol is not found in soy, but is converted from daidzein by human gut bacterial flora. Research indicates that between 30-50% of the population is capable of converting daidzein to equol; therefore, ther...

Dietary fats in food are natural energy sources to animals and are included in the American Association of Feed Control Officials (AAFCO) manual as a requirement for dog food. Medium chain triglycerides are comprised of a glycerol backbone esterified to medium chain length (8-12 carbon) fatty acids (FA) and, in the context of this report, are all s...

Methylsulfonylmethane (MSM) is a metabolite of dimethyl sulfoxide, and occurs naturally at low levels in many foods. MSM has received wide attention as a dietary supplement to promote joint health. The objective of these studies was to determine the developmental toxicity potential of MSM when administered orally to pregnant rats during the period...

Selenium has been recognized as an essential nutrient for human health; however, its bioavailability is primarily dependent upon the type of selenium, elemental versus organic. In geographic areas low in selenium, there is the potential for animals (including humans) to become selenium deficient and this potential deficiency can be remedied by cons...

Selenium, recognized as an essential nutrient for human health, is a component of proteins and enzymes required for various biological functions and is currently being used as a feed supplement for livestock in geographical areas that are naturally low in selenium. Selenium is structurally similar to sulfur, replacing the sulfur atom in stoichiomet...

To reduce the incorporation of dietary lipids into adipose tissue, modified fats and oils have been developed, such as medium-chain triacylglycerols (MCT). Typical dietary lipids from vegetable oils, termed long-chain triacylglycerols (LCT), are degraded by salivary, intestinal and pancreatic lipases into two fatty acids and a monoacyl glycerol; wh...

Experimental and epidemiological studies indicate that consumption of tomato products containing high amounts of lycopene is associated with lowered cancer risk. The protective effects of lycopene may be related to its antioxidant potential. Lycopene has been demonstrated to inhibit oxidation. A proprietary, natural tomato oleoresin extract (NTOE),...

Each year, 75 million pounds of the broadleaf herbicide atrazine (ATR) are applied to crops in the United States. Despite limited solubility, ATR is common in ground and surface water, making it of regulatory concern. ATR suppresses the immunomodulatory hormones prolactin (PRL) and the thyroid hormones (THs), with developmental exposure to ATR perm...

Exposure to ubiquitous environmental chemicals, such as polycyclic aromatic hydrocarbons (PAH), may contribute to human breast cancer. In animals, PAH induce tumors in part by activating the aryl hydrocarbon receptor (AhR)/transcription factor. Historically, investigations into AhR-regulated carcinogenesis have focused on AhR-dependent transcriptio...

Exposure to ubiquitous environmental chemicals, such as polycyclic aromatic hydrocarbons (PAH), may contribute to human breast cancer. In animals, PAH induce tumors in part by activating the aryl hydrocarbon receptor (AhR)/transcription factor. Historically, investigations into AhR-regulated carcinogenesis have focused on AhR-dependent transcriptio...

Previous studies indicated that two prototypic PAH, benzo[a]pyrene (B[a]P) and 7,12-dimethylbenz[a]anthracene (DMBA), suppress the developing immune system by inducing apoptosis in bone marrow pre-B lymphocytes. In bone marrow cultures consisting of pre-B cells growing on bone marrow stromal cell monolayers, pre-B cell apoptosis was shown to be dep...

Polycyclic aromatic hydrocarbons (PAH) are environmental chemicals that mediate immunosuppression. In long-term bone marrow B-cell lymphopoiesis models, PAH induce apoptosis in immature (preB) lymphocytes. Since the biologic function of PAH is often mediated by the aryl hydrocarbon receptor/transcription factor (AhR), the role of the AhR or AhR-reg...

Numerous studies demonstrate that polycyclic aromatic hydrocarbons (PAH) suppress immunity by modifying the function of both B and T cells. Relatively few studies have assessed the effects of these common environmental chemicals on immature lymphocytes. In the present study, long-term primary bone marrow cultures were employed to investigate the ef...

Lactacystin, a microbial metabolite that inhibits protease activity only in the proteasome, was used to study the role of the proteasome in the activation-induced cell death (AICD) of T cells. Lactacystin induces DNA fragmentation and apoptosis in a T cell hybridoma (DO.11. 10) in a dose-dependent manner. Between 1 and 10 microM, the mildly cytotox...

In the absence of known endogenous ligands, investigators have exploited ubiquitous environmental pollutants, including polycyclic aromatic hydrocarbons, to gain insight into the physiologic functions of the aryl hydrocarbon (dioxin) receptor/transcription factor (AhR). AhR ligands induce cell transformation and steroid-like immunosuppression, sugg...

The goal of these studies was to characterize the role played by antigen challenge in 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)-induced immunosuppression. The effects of single exposure to TCDD (4.2, 14, and 42 microg/kg) in B6C3F1 mice on the reverse plaque assay (RPA; no sensitization) and the sheep red blood cell (SRBC) antibody response were c...

A model has been developed in which acute cocaine administration results in an enhanced T-dependent antibody response to sheep erythrocytes. This enhancement occurs when cocaine (30 mg/kg, twice in 1 day) is administered 1 or 2 days before sensitization with antigen, in mice older than 16 wk. Acute cocaine has been shown to elicit a rise in serum c...

The objective of these studies was to determine if the immunotoxic effects of cocaine in mice are sex- and strain-dependent, a profile of activity previously described for cocaine-induced hepatotoxicity. The latter effect has been attributed to differences in the metabolism of cocaine by the cytochrome P-450 system. Subchronic, (14-day) in vivo adm...

Our laboratory has proposed a working model which asserts that cocaine's effects on immunity are mediated by reactive metabolites generated by the cytochrome P-450 system. This metabolic pathway is normally a minor one in humans, but takes on significance when metabolism of cocaine by the P-450 system is increased, as may occur with excessive alcoh...

Humoral immune responses to either T-independent or T-dependent antigens have previously been shown to be suppressed by the halogenated aromatic hydrocarbon environmental contaminant 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) through direct action on B-lymphocytes. To better understand the molecular nature of the TCDD-induced suppression of B-cell...

The primary objective of this paper was to characterize the role of metabolism in immunosuppression by acute exposure to cocaine. beta-Ionone has been used to study the role of metabolism in hepatotoxicity associated with acute exposure to cocaine, and was shown to produce a greater effect than other cytochrome P-450 (P-450) inducers. When beta-ion...

Polycyclic aromatic hydrocarbons (PAH) are thought to compromise the immune system, perhaps through apoptosis of lymphocytes. Data indicates that this apoptotic process is mediated via the aromatic hydrocarbon receptor (AhR). To determine the role of AhR in the lymphocyte microenvironment on the apoptosis of preB cells, cultures containing a stroma...

Cocaine has been reported to directly suppress the in vitro immune responses at very high concentrations. In the present study, the possible role of metabolism in cocaine-induced immunosuppression was investigated in splenocyte cultures isolated from B6C3F1 female mice. Since cocaine can be metabolized by both esterase and P-450 monooxygenase, we s...

To investigate the role of metabolism in cocaine-induced immunosuppression, diazinon and beta-ionone were administered as an esterase inhibitor and a cytochrome P-450 (P-450) inducer, respectively, to B6C3F1 female mice. When 10 or 30 mg/kg of diazinon was administered 30 min before cocaine (30 mg/kg) was administered i.p. for 7 consecutive days, t...

The biodisposition of cocaine and norcocaine in blood and tissues of immunological importance in B6C3F1 mice following exposure to cocaine or cocaine plus an organophosphate esterase inhibitor, diazinon, is presented. Analysis of specimens was by gas chromatography-mass spectrometry. Results from these studies indicate that pretreatment with diazin...

Although drug abuse has been widely discussed as a possible co-factor in the onset and/or progression of AIDS, available literature is not consistent with cocaine use being associated with marked effects on immunocompetence. The initial objective of the present investigation was to determine the effects of cocaine on immunocompetence following dire...