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Mass Balance and Absorption, Distribution, Metabolism, and Excretion Properties of Balcinrenone following Oral Administration in Combination with Intravenous Microtracer in Healthy Subjects

Lindmark, B. (author), Li, X.Q. (author), Bhattacharya, C. (author), Housler, G. (author), Heijer, M. (author), Bragg, R.A. (author), Gränfors, M. (author), Pelay-Gimeno, M. (author), Vaes, W.H.J. (author), Menakuru, S. (author), Pizzato, P.E. (author), Ericsson, H. (author), Johansson, S. (author)

An absorption, distribution, metabolism, and excretion study was performed to determine the basic pharmacokinetic parameters, mass balance, and metabolite profiles of balcinrenone, a mineralocorticoid receptor modulator, in humans. This open-label, single-center, nonrandomized study had a two-period design. In period 1, eight healthy male...

article 2023

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Using data from food challenges to inform management of consumers with food allergy: A systematic review with individual participant data meta-analysis

Patel, N. (author), Adelman, D.C. (author), Anagnostou, K. (author), Baumert, J.L. (author), Blom, W.M. (author), Campbell, D.E. (author), Chinthrajah, R.S. (author), Mills, E.N.C. (author), Javed, B. (author), Purington, N. (author), Remington, B.C. (author), Sampson, H.A. (author), Smith, A.D. (author), Yarham, R.A.R. (author), Turner, P.J. (author)

Background Eliciting doses (EDs) (eg, ED01 or ED05 values, which are the amounts of allergen expected to cause objective symptoms in 1% and 5% of the population with an allergy, respectively) are increasingly being used to inform allergen labeling and clinical management. These values are generated from food challenge, but the frequency of...

article 2021

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Threshold Dose Distribution in Walnut Allergy

TNO Kwaliteit van Leven (author), Blankestijn, M.A. (author), Remington, B.C. (author), Houben, G.F. (author), Baumert, J.L. (author), Knulst, A.C. (author), Blom, W.M. (author), Klemans, R.J.B. (author), Taylor, S.L. (author)

Background In food allergy, eliciting doses (EDs) of foods on a population level can improve risk management and labeling strategies for the food industry and regulatory authorities. Previously, data available for walnut were unsuitable to determine EDs. Objective The objective of this study was to determine EDs for walnut allergic adults and to...

article 2017

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Assessing the safety of cosmetic chemicals Consideration of a flux decision tree to predict dermally delivered systemic dose for comparison with oral TTC (Threshold of Toxicological Concern)

Williams, F.M. (author), Rothe, H. (author), Barrett, G. (author), Chiodini, A. (author), Whyte, J. (author), Cronin, M.T.D. (author), Monteiro-Riviere, N.A. (author), Plautz, J. (author), Roper, C. (author), Westerhout, J. (author), Yang, C. (author), Guy, R.H. (author)

Threshold of Toxicological Concern (TTC) aids assessment of human health risks from exposure to low levels of chemicals when toxicity data are limited. The objective here was to explore the potential refinement of exposure for applying the oral TTC to chemicals found in cosmetic products, for which there are limited dermal absorption data. A...

article 2016

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Choline supplemented as phosphatidylcholine decreases fasting and postmethionine-loading plasma homocysteine concentrations in healthy men

Olthof, M.R. (author), Brink, E.J. (author), Katan, M.B. (author), Verhoef, P. (author), TNO Kwaliteit van Leven (author)

Background: A high homocysteine concentration is a potential risk factor for cardiovascular disease that can be reduced through betaine supplementation. Choline is the precursor for betaine, but the effects of choline supplementation on plasma total homocysteine (tHcy) concentrations in healthy humans are unknown. Objective: The objective was to...

article 2005

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Disposition of 14C-α-cyclodextrin in germ-free and conventional rats

van Ommen, B. (author), de Bie, A.T.H.J. (author), Bär, A. (author), TNO Voeding (author)

The absorption, disposition, metabolism, and excretion of uniformly 14C-labeled α-cyclodextrin (14C-α-CD) was examined in four separate experiments with Wistar rats. In Experiment 1, 14C-α-CD (25μCi, 50mg/kg bw) was administered intravenously to four male and four female conventional rats. In Experiment 2, 14C-α-CD (25μCi, 200mg/kg bw) was given...

article 2004

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Effect of fumonisin B1 on rat hepatic P450 system

Spotti, M. (author), Maas, R.F.M. (author), de Nijs, C.M. (author), Fink-Gremmels, J. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

The effects of the mycotoxin fumonisin B1 (FB1) on the hepatic cytochrome P450 system were investigated in male rats dosed daily by oral gavage with 3 mg FB1 per kg body weight for 9 consecutive days. FB1 treatment resulted in a reduced weight gain. At the same time, CYP2E activity was increased, which is considered to mark the metabolic changes...

article 2000

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Effect of mass media campaign to reduce socioeconomic differences in women's awareness and behaviour concerning use of folic acid: Cross sectional study

de Walle, H.E.K. (author), van der Pal, K.M. (author), van den Berg, L.T.W. (author), Jeeninga, W. (author), Schouten, J.S.A.G. (author), de Rover, C.M. (author), Buitendijk, S.E. (author), Cornel, M.C. (author), TNO Arbeid (author)

Chemicals/CAS: Folic Acid, 59-30-3

article 1999

document

The β-adrenoceptor agonist clenbuterol is a potent inhibitor of the LPS-induced production of TNF-α and IL-6 in vitro and in vivo

Izeboud, C.A. (author), Monshouwer, M. (author), van Miert, A.S.J.P.A.M. (author), Witkamp, R.F. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

Objective and Design: To investigate the suppressive effects of the β-agonist clenbuterol on the release of TNF-α and IL-6 in a lipopolysaccharide (LPS)-model of inflammation, both in vitro and in vivo. Material and Subjects: Human U-937 cell line (monocyte-derived macrophages), and male Wistar rats (200-250 g). Treatment: U-937 macrophages were...

article 1999

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In vitro and in vivo inhibition of human flavin-containing monooxygenase form 3 (FMO3) in the presence of dietary indoles

Cashman, J.R. (author), Xiong, Y. (author), Lin, J. (author), Verhagen, H. (author), van Poppel, G. (author), van Bladeren, P.J. (author), Larsen-Su, S. (author), Williams, D.E. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

The effect of consumption of glucosinolate-containing Brussels sprouts on flavin-containing monooxygenase functional activity in humans was investigated in 10 healthy, male, non-smoking volunteers. After a 3-week run-in period, 5 volunteers continued on a glucosinolate-free diet for 3 weeks (control group), and 5 others consumed 300 g of cooked...

article 1999

document

Intestinal T lymphocytes of different rat strains in immunotoxicity

Bruder, M.C. (author), Spanhaak, S. (author), Bruijntjes, J.P. (author), Michielsen, C.P.P.C. (author), Vos, J.G. (author), Kuper, C.F. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

In order to study the intestinal mucosal immune cells, with emphasis on single T lymphocytcs, an inventory was made of single and organized lymphocytes in the epithelium and lamina propria of the small intestines of untreated Wistar, Fischer 344, and Lewis rats. The single and organized lymphocytes were examined microscopically. In addition, the...

article 1999

document

Quantification of perifosine, an alkylphosphocholine anti-tumour agent, in plasma by pneumatically assisted electrospray tandem mass spectrometry coupled with high-performance liquid chromatography

Knebel, N.G. (author), Grieb, S. (author), Winkler, M. (author), Locher, M. (author), van der Vlis, E. (author), Verheij, E.R. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

An HPLC assay with tandem mass spectrometric detection in the positive-ion Turbo-Ion-Spray((TM)) (TISP) mode for the fast and sensitive determination of perifosine ((I), D-21266) in human plasma was developed, utilising the structural analogue, miltefosine ((II), D-18506), as internal standard. Automated solid-phase extraction of diluted plasma...

article 1999

document

13-week oral toxicity study with stanol esters in rats

Turnbull, D. (author), Whittaker, M.H. (author), Frankos, V.H. (author), Jonker, D. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

Plant sterols and their saturated derivatives, known as stanols, reduce serum cholesterol when consumed in amounts of approximately 2 g per day. Stanol fatty acid esters have been developed as a highly fat-soluble form that may lower cholesterol more effectively than stanols. Stanol esters occur naturally in human diets, but at levels far below...

article 1999

document

Instruments for oral disease-intervention strategies: Recombinant Lactobacillus casei expressing tetanus toxin fragment C for vaccination or myelin proteins for oral tolerance induction in multiple sclerosis

Maassen, C.B.M. (author), Laman, J.D. (author), Heijne den Bak-Glashouwer, M.J. (author), Tielen, F.J. (author), van Holten-Neelen, J.C.P.A. (author), Hoogteijling, L. (author), Antonissen, C. (author), Leer, R.J. (author), Pouwels, P.H. (author), Boersma, W.J.A. (author), Shaw, D.M. (author)

Lactobacillus strains possess properties that make them attractive candidates as vehicles for oral administration of therapeutics. In this report we describe the construction and analysis of recombinant Lactobacillus casei applicable in oral vaccination against an infectious disease (tetanus) and in oral tolerance induction for intervention in...

article 1999

document

Oligofructose stimulates calcium absorption in adolescents

van den Heuvel, E.G.H.M. (author), Muys, T. (author), van Dokkum, W. (author), Schaafsma, G. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

Background: In rats, nondigestible oligosaccharides stimulate calcium absorption. Recently, this effect was also found in human subjects. Objective: The objective of the study was to investigate whether consumption of 15 g oligofructose/d stimulates calcium absorption in male adolescents. Design: Twelve healthy, male adolescents aged 14-16 y...

article 1999

document

Safety assessment of lactate esters

Clary, J.J. (author), Feron, V.J. (author), van Velthuijsen, J.A. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

Lactate eaters have an oral LD50 greater than 2000 mg/kg and the inhalation LC50 is generally above 5000 mg/m3 and they may be potential eye and skin irritants, but not skin sensitizers. No evidence of teratogenicity or maternal toxicity was observed in an inhalation (2-ethylhexyl-L-lactate) or dermal study (ethyl-L-lactate). Subacute inhalation...

article 1998

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Disposition of [14C]γ-cyclodextrin in germ-free and conventional rats

de Bie, A.T.H.J. (author), van Ommen, B. (author), Bär, A. (author), Centraal Instituut voor Voedingsonderzoek TNO (author)

The absorption, disposition, metabolism, and excretion of 14C-labeled γ-cyclodextrin ([14C]γ-CD) was examined in four separate experiments with Wistar rats. In experiment 1, [14C]γ-CD (25 μCi, 600 mg/kg body wt) was administered intravenously to four male and four female conventional rats. In experiment 2, [14C]γ- CD (25 μCi, 1000 mg/kg body wt)...

article 1998

document

Subchronic (13-week) oral toxicity study of y-cyclodextrin in dogs

Til, H.P. (author), Bär, A. (author)

The oral toxicity of γ-cyclodextrin (γ- CD) was examined in a 13-week feeding study in which four groups of four male and four female Beagle dogs received γ-CD in the diet at concentrations of 0 (control), 5, 10, or 20%. No treatment-related changes were noted in behavior or appearance of the dogs and no mortalities occurred. Transient diarrhea...

article 1998

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Tranexamic acid, an inhibitor of plasminogen activation, reduces urinary collagen cross-link excretion in both experimental and rheumatoid arthritis

Ronday, H.K. (author), TeKoppele, J.M. (author), Greenwald, R.A. (author), Moak, S.A. (author), de Roos, J.A.D.M. (author), Dijkmans, B.A.C. (author), Breedveld, F.C. (author), Verheijen, J.H. (author), Gaubius Instituut TNO (author)

The plasminogen activation system is one of the enzyme systems held responsible for bone and cartilage degradation in rheumatoid arthritis (RA). In this study, we evaluated the effect of tranexamic acid (TEA), an inhibitor of plasminogen activation, on urinary collagen cross-link excretion and radiological joint damage in rat adjuvant arthritis ...

article 1998

document

Embryotoxicity and teratogenicity study with y-cyclodextrin in rabbits

Waalkens-Berendsen, D.H. (author), Smits-van Prooije, A.E. (author), Bär, A. (author)

In a standard embryotoxicity/teratogenicity study, γ-cyclodextrin (γ-CD) was administered to groups of 16, artificially inseminated New Zealand White rabbits at dietary concentrations of 0, 5, 10, or 20%. A comparison group received a diet containing 20% lactose. Treatment started on day 0 of gestation and ended on day 29 when the animals were...

article 1998