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Catalytic nucleotide-hydrolyzing antibodies in milk and serum of clinically healthy human mothers.

https://arctichealth.org/en/permalink/ahliterature63416
Source
Med Sci Monit. 2004 Feb;10(2):BR23-33
Publication Type
Article
Date
Feb-2004
Author
Dmitry V Semenov
Tat'yana G Kanyshkova
Nataliya A Karotaeva
Mikhail A Krasnorutskii
Irina A Kuznetsova
Valentina N Buneva
Gregory A Nevinsky
Author Affiliation
Novosibirsk Institute of Bioorganic Chemistry, Siberian Division of the Russian Academy of Sciences, Novosibirsk 630090, Lavrientieva Avenue 8, Russia.
Source
Med Sci Monit. 2004 Feb;10(2):BR23-33
Date
Feb-2004
Language
English
Publication Type
Article
Keywords
Adenosine Monophosphate - analogs & derivatives - metabolism
Adenosine Triphosphate - analogs & derivatives - metabolism
Adenosinetriphosphatase - metabolism
Adult
Antibodies, Catalytic - blood - isolation & purification - metabolism
Comparative Study
Female
Humans
Hydrolysis
Immunoglobulin Fab Fragments - chemistry - isolation & purification - metabolism
Immunoglobulin G - isolation & purification - metabolism
Immunoglobulin Heavy Chains - metabolism
Immunoglobulin Light Chains - metabolism
Kinetics
Lactation
Milk, Human - chemistry - immunology
Nucleotides - chemistry - metabolism
Phosphorus Radioisotopes
Pregnancy
Research Support, Non-U.S. Gov't
Serum - chemistry
Abstract
BACKGROUND: In humans, pregnancy and lactation are associated with the production of catalytically active antibodies (abzymes) in serum and breast milk. However, the substrate specificities of the abzymes in these biological fluids, particularly breast milk, have not been studied MATERIAL/METHODS: IgG fractions were isolated from human milk by subsequent steps of chromatographic purification on Protein-A Sepharose, DEAE-cellulose, and anti-IgG Sepharose. The nucleotide-hydrolyzing activity of electrophoretically homogeneous IgG antibodies was measured using 32P-labeled nucleotides and TLC. RESULTS: We demonstrated by different methods that IgG antibodies from the serum and milk of clinically healthy human mothers are able to hydrolyze ribo- and deoxyribonucleoside-5'-mono, di- and triphosphates; this nucleotide-hydrolyzing activity was also present in Fab fragments of the IgG molecule. Affinity modification of the milk IgG oligomeric form by chemically reactive derivatives of ATP led to preferential modification of the L-chain. However, after separation of the subunits by SDS electrophoresis, an in-gel assay showed ATP-hydrolyzing activity in various oligomeric forms of IgG subunits (H2L2, H2L and HL), while the separated heavy (H) and light (L) chains were not catalytically active. The Km and Vmax values characterizing the interaction of IgG with nucleotides were estimated. CONCLUSIONS: Our findings speak in favor of the generation of a variety of polyclonal nucleotide-hydrolyzing antibodies by the immune system of clinically healthy mothers.
PubMed ID
14737037 View in PubMed
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Cobalamin and haptocorrin in human milk and cobalamin-related variables in mother and child: a 9-mo longitudinal study.

https://arctichealth.org/en/permalink/ahliterature112927
Source
Am J Clin Nutr. 2013 Aug;98(2):389-95
Publication Type
Article
Date
Aug-2013
Author
Eva Greibe
Dorte L Lildballe
Súsanna Streym
Peter Vestergaard
Lars Rejnmark
Leif Mosekilde
Ebba Nexo
Author Affiliation
Department of Clinical Biochemistry, Aarhus University Hospital, Norrebrogade 44, Building 9, 8000 Aarhus C, Denmark. evagreibe@gmail.com
Source
Am J Clin Nutr. 2013 Aug;98(2):389-95
Date
Aug-2013
Language
English
Publication Type
Article
Keywords
Adult
Biological Markers - blood
Denmark
European Continental Ancestry Group
Female
Humans
Lactation
Longitudinal Studies
Methylmalonic Acid - blood
Milk, human - chemistry
Mothers
Postpartum Period
Transcobalamins - analysis - metabolism
Vitamin B 12 - analysis - blood
Young Adult
Abstract
Measurement of milk cobalamin is hampered by the high content of the cobalamin-binding protein haptocorrin, and limited data are available relating trustworthy measures of milk cobalamin to cobalamin status in healthy mothers and their children.
The objectives were to explore the concentration of cobalamin and haptocorrin in foremilk and hindmilk during the first 9 mo of lactation and to relate these results to biomarkers of an impaired cobalamin status of mother and child.
Milk samples from 25 mothers were collected at 2 wk, 4 mo, and 9 mo postpartum for the measurement of cobalamin and haptocorrin. Plasma samples from a larger cohort of lactating mothers (n = 107) and their infants (n = 108) were collected at the same time points for the measurement of cobalamin, holotranscobalamin, total transcobalamin, total haptocorrin, and methylmalonic acid.
Median (range) concentrations of cobalamin in hindmilk were 760 (210-1880), 290 (140-690), and 440 (160-1940) pmol/L at 2 wk, 4 mo, and 9 mo, respectively; the respective haptocorrin concentrations were 25 (9-102), 22 (4-100), and 180 (30-460) nmol/L. We found slightly lower values in foremilk. A decrease in milk cobalamin at 4 mo was associated with decreases in plasma cobalamin (P , 0.0001) and holotranscobalamin (P , 0.0001) in the infants. Strong positive associations in paired maternal-infant cobalamin concentrations were found at all time points.
Foremilk and hindmilk contained comparable amounts of cobalamin and haptocorrin, but marked changes were observed during 9 mo of lactation. At 4 mo, low concentrations of milk cobalamin mirrored biochemical changes in infants, which suggests an impaired cobalamin status and indicates that nutrition from only mother's milk may not be sufficient for the supply of cobalamin from this age. This trial was registered by the Danish Data Protection Agency at www.datatilsynet.dk/english as 2008-41-2185.
PubMed ID
23783295 View in PubMed
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Determinants of changes in vitamin D status postpartum in Swedish women.

https://arctichealth.org/en/permalink/ahliterature272905
Source
Br J Nutr. 2016 Feb 14;115(3):422-30
Publication Type
Article
Date
Feb-14-2016
Author
Petra Brembeck
Anna Winkvist
Mari Bååth
Linnea Bärebring
Hanna Augustin
Source
Br J Nutr. 2016 Feb 14;115(3):422-30
Date
Feb-14-2016
Language
English
Publication Type
Article
Keywords
Adult
Diet Records
Dietary Supplements
European Continental Ancestry Group
Female
Humans
Lactation
Linear Models
Milk, human - chemistry
Multivariate Analysis
Postpartum Period - blood
Seasons
Sunlight
Sweden - epidemiology
Vitamin D - blood
Vitamin D Deficiency - blood - epidemiology
Abstract
Low vitamin D status has been associated with unfavourable health outcomes. Postpartum, it is speculated that maternal vitamin D status decreases due to transfer of vitamin D from mother to child through breast milk. A few studies have investigated changes in maternal vitamin D postpartum and possible determinants. Thus, the aims of the present study were to determine changes in serum concentrations of 25-hydroxyvitamin D (25(OH)D) between 2 weeks and 12 months postpartum in Swedish women and to evaluate lactation and other determinants for changes in 25(OH)D concentration postpartum. In total, seventy-eight women were studied at 2 weeks, 4 months and 12 months postpartum. Data collection included measurements of weight and height as well as information about lactation, sun exposure, use of oestrogen contraceptives and physical activity level. Blood samples were collected and serum 25(OH)D levels were analysed using liquid chromatography-tandem MS. Dietary intake of vitamin D was recorded using 4-d food diaries. For all the women studied, mean serum 25(OH)D did not change between 2 weeks and 12 months postpartum (67 (SD 23) v. 67 (SD 19) nmol/l). No association was found between lactation and changes in serum 25(OH)D concentration postpartum. Significant determinants for postpartum changes in 25(OH)D concentration were use of vitamin D supplements (P=0·003), use of oestrogen contraceptives (P=0·013) and season (P=0·005). In conclusion, no changes were observed in 25(OH)D concentrations during the 1st year postpartum in these women and no association was found between lactation and changes in 25(OH)D concentration postpartum. The main determinants for the variation in changes in 25(OH)D concentrations postpartum were use of vitamin D supplements, use of oestrogen contraceptives and season.
PubMed ID
26586446 View in PubMed
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Diet and blood pressure in 2.5-y-old Danish children.

https://arctichealth.org/en/permalink/ahliterature30321
Source
Am J Clin Nutr. 2004 Jun;79(6):1095-102
Publication Type
Article
Date
Jun-2004
Author
Janne Ulbak
Lotte Lauritzen
Harald S Hansen
Kim F Michaelsen
Author Affiliation
Centre for Advanced Food Studies, Department of Human Nutrition, The Royal Veterinary and Agricultural University, Frederiksberg, Denmark.
Source
Am J Clin Nutr. 2004 Jun;79(6):1095-102
Date
Jun-2004
Language
English
Publication Type
Article
Keywords
Animals
Birth weight
Blood Pressure - drug effects
Child, Preschool
Denmark
Diet
Energy intake
Fatty Acids, Omega-3
Fatty Acids, Unsaturated - administration & dosage - pharmacology
Female
Fishes
Humans
Lactation
Male
Milk, human - chemistry
Regression Analysis
Research Support, Non-U.S. Gov't
Triglycerides - administration & dosage - pharmacology
Abstract
BACKGROUND: Blood pressure tracks from childhood into adulthood, and early diet may have long-term effects on hypertension. OBJECTIVE: The study's aim was to investigate whether intakes of n-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFAs) during lactation and current intakes of macronutrients affect blood pressure in 2.5-y-old Danish children. DESIGN: Mothers (n =122) with low fish intakes were randomly assigned to receive supplementation with 4.5 g fish oil or olive oil/d during the first 4 mo of lactation. The trial also included 53 mothers with high fish intakes. One hundred five of these women's children attended a 2.5-y follow-up examination at which anthropometric data and blood pressure were obtained. Mothers then kept a 7-d dietary record of food consumed by their children. A full set of data from 73 children was analyzed for effects of fish oil supplementation and cross-sectional correlations with current diet. RESULTS: We found no significant effect of the mothers' fish oil intakes during the first 4 mo of lactation on the blood pressure of the children 2.5 y later. Greater protein intakes measured as a percentage of energy were associated cross-sectionally with significantly lower diastolic and systolic blood pressures in the children at age 2.5 y after control for outdoor temperature, age, sex, weight, and height (P = 0.028 and 0.035, respectively). Greater protein intakes measured as g/d were also associated with significantly lower systolic blood pressures (P = 0.008). A 1-SD increase in protein intake corresponded with a decrease of approximately 3 mm Hg in systolic blood pressure. CONCLUSION: The blood pressure of young Danish children was not significantly affected by intakes of n-3 LC-PUFAs via breast milk, but greater protein intakes at 2.5 y were associated with lower blood pressure.
PubMed ID
15159241 View in PubMed
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Exposure of perfluorinated chemicals through lactation: levels of matched human milk and serum and a temporal trend, 1996-2004, in Sweden.

https://arctichealth.org/en/permalink/ahliterature78297
Source
Environ Health Perspect. 2007 Feb;115(2):226-30
Publication Type
Article
Date
Feb-2007
Author
Kärrman Anna
Ericson Ingrid
van Bavel Bert
Darnerud Per Ola
Aune Marie
Glynn Anders
Lignell Sanna
Lindström Gunilla
Author Affiliation
Man-Technology-Environment (MTM) Research Centre, Orebro University, Orebro, Sweden. anna.karrman@nat.oru.se
Source
Environ Health Perspect. 2007 Feb;115(2):226-30
Date
Feb-2007
Language
English
Publication Type
Article
Keywords
Breast Feeding
Female
Fluorocarbons - analysis - blood
Humans
Lactation
Maternal Exposure
Milk, human - chemistry
Risk assessment
Sweden
Abstract
BACKGROUND: Only limited data exist on lactation as an exposure source of persistent perfluorinated chemicals (PFCs) for children. OBJECTIVES: We studied occurrence and levels of PFCs in human milk in relation to maternal serum together with the temporal trend in milk levels between 1996 and 2004 in Sweden. Matched, individual human milk and serum samples from 12 primiparous women in Sweden were analyzed together with composite milk samples (25-90 women/year) from 1996 to 2004. RESULTS: Eight PFCs were detected in the serum samples, and five of them were also above the detection limits in the milk samples. Perfluorooctanesulfonate (PFOS) and perfluorohexanesulfonate (PFHxS) were detected in all milk samples at mean concentrations of 0.201 ng/mL and 0.085 ng/mL, respectively. Perfluorooctanesulfonamide (PFOSA), perfluorooctanoic acid (PFOA), and perfluorononanoic acid (PFNA) were detected less frequently. DISCUSSION: The total PFC concentration in maternal serum was 32 ng/mL, and the corresponding milk concentration was 0.34 ng/mL. The PFOS milk level was on average 1% of the corresponding serum level. There was a strong association between increasing serum concentration and increasing milk concentration for PFOS (r(2) = 0.7) and PFHxS (r(2) = 0.8). PFOS and PFHxS levels in composite milk samples were relatively unchanged between 1996 and 2004, with a total variation of 20 and 32% coefficient of variation, respectively. CONCLUSION: The calculated total amount of PFCs transferred by lactation to a breast-fed infant in this study was approximately 200 ng/day. Lactation is a considerable source of exposure for infants, and reference concentrations for hazard assessments are needed.
PubMed ID
17384769 View in PubMed
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Immune Components in Human Milk Are Associated with Early Infant Immunological Health Outcomes: A Prospective Three-Country Analysis.

https://arctichealth.org/en/permalink/ahliterature291315
Source
Nutrients. 2017 May 24; 9(6):
Publication Type
Journal Article
Date
May-24-2017
Author
Daniel Munblit
Marina Treneva
Diego G Peroni
Silvia Colicino
Li Yan Chow
Shobana Dissanayeke
Alexander Pampura
Attilio L Boner
Donna T Geddes
Robert J Boyle
John O Warner
Author Affiliation
Department of Paediatrics, Imperial College London, London W2 1NY, UK. daniel.munblit08@imperial.ac.uk.
Source
Nutrients. 2017 May 24; 9(6):
Date
May-24-2017
Language
English
Publication Type
Journal Article
Keywords
Colostrum - chemistry - immunology
Eczema - epidemiology - immunology - prevention & control
Female
Follow-Up Studies
Hepatocyte Growth Factor - analysis
Humans
Hypersensitivity, Immediate - epidemiology - immunology - prevention & control
Infant
Interleukin-13 - analysis
Interleukin-2 - analysis
Italy
Lactation
Male
Milk, Human - chemistry - immunology
Pregnancy
Prevalence
Prospective Studies
Russia
Surveys and Questionnaires
Transforming Growth Factor beta2 - analysis
United Kingdom
Abstract
The role of breastfeeding in improving allergy outcomes in early childhood is still unclear. Evidence suggests that immune mediators in human milk (HM) play a critical role in infant immune maturation as well as protection against atopy/allergy development. We investigated relationships between levels of immune mediators in colostrum and mature milk and infant outcomes in the first year of life. In a large prospective study of 398 pregnant/lactating women in the United Kingdom, Russia and Italy, colostrum and mature human milk (HM) samples were analysed for immune active molecules. Statistical analyses used models adjusting for the site of collection, colostrum collection time, parity and maternal atopic status. Preliminary univariate analysis showed detectable interleukin (IL) 2 and IL13 in HM to be associated with less eczema. This finding was further confirmed in multivariate analysis, with detectable HM IL13 showing protective effect OR 0.18 (95% CI 0.04-0.92). In contrast, a higher risk of eczema was associated with higher HM concentrations of transforming growth factor ß (TGFß) 2 OR 1.04 (95% CI 1.01-1.06) per ng/mL. Parental-reported food allergy was reported less often when IL13 was detectable in colostrum OR 0.10 (95% CI 0.01-0.83). HM hepatocyte growth factor (HGF) was protective for common cold incidence at 12 months OR 0.19 (95% CI 0.04-0.92) per ng/mL. Data from this study suggests that differences in the individual immune composition of HM may have an influence on early life infant health outcomes. Increased TGFß2 levels in HM are associated with a higher incidence of reported eczema, with detectable IL13 in colostrum showing protective effects for food allergy and sensitization. HGF shows some protective effect on common cold incidence at one year of age. Future studies should be focused on maternal genotype, human milk microbiome and diet influence on human milk immune composition and both short- and long-term health outcomes in the infant.
Notes
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PubMed ID
28538696 View in PubMed
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Impact of maternal diet on human milk composition and neurological development of infants.

https://arctichealth.org/en/permalink/ahliterature105050
Source
Am J Clin Nutr. 2014 Mar;99(3):734S-41S
Publication Type
Article
Date
Mar-2014
Author
Sheila M Innis
Author Affiliation
Nutrition and Metabolism Research Program, Child and Family Research Institute, Department of Pediatrics, Faculty of Medicine, University of British Columbia, Vancouver, Canada.
Source
Am J Clin Nutr. 2014 Mar;99(3):734S-41S
Date
Mar-2014
Language
English
Publication Type
Article
Keywords
Adult
Breast Feeding
Canada
Child Development
Diet - adverse effects
Evidence-Based Medicine
Fatty Acids, Essential - administration & dosage - analysis - secretion
Female
Humans
Infant
Infant, Newborn
Lactation
Male
Maternal Nutritional Physiological Phenomena
Milk, Human - chemistry - secretion
Neurogenesis
United States
Abstract
Maternal nutrition has little or no effect on many nutrients in human milk; for others, human milk may not be designed as a primary nutritional source for the infant; and for a few, maternal nutrition can lead to substantial variations in human milk quality. Human milk fatty acids are among the nutrients that show extreme sensitivity to maternal nutrition and are implicated in neurological development. Extensive development occurs in the infant brain, with growth from ~ 350 g at birth to 925 g at 1 y, with this growth including extensive dendritic and axonal arborization. Transfer of n-6 (omega-6) and n-3 (omega-3) fatty acids from the maternal diet into human milk occurs with little interconversion of 18:2n-6 to 20:4n-6 or 18:3n-3 to docosahexaenoic acid (DHA) and little evidence of mammary gland regulation to maintain individual fatty acids constant with varying maternal fatty acid nutrition. DHA has gained attention because of its high concentrations and roles in the brain and retina. Studies addressing DHA intakes by lactating women or human milk amounts of DHA at levels above those typical in the United States and Canada on infant outcomes are inconsistent. However, separating effects of the fatty acid supply in gestation or in the weaning diet from effects on neurodevelopment solely due to human milk fatty acids is complex, particularly when neurodevelopment is assessed after the period of exclusive human milk feeding. Information on infant fatty acid intakes, including milk volume consumed and energy density, will aid in understanding of the human milk fatty acids that best support neurological development.
PubMed ID
24500153 View in PubMed
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Lead and cadmium levels in human milk and blood.

https://arctichealth.org/en/permalink/ahliterature67713
Source
Sci Total Environ. 1995 Apr 21;166:149-55
Publication Type
Article
Date
Apr-21-1995
Author
I P Hallén
L. Jorhem
B J Lagerkvist
A. Oskarsson
Author Affiliation
Toxicology Division Swedish National Food Administration, Uppsala.
Source
Sci Total Environ. 1995 Apr 21;166:149-55
Date
Apr-21-1995
Language
English
Publication Type
Article
Keywords
Analysis of Variance
Cadmium - blood - pharmacokinetics
Chemical Industry
Environmental Pollutants - blood - pharmacokinetics
Female
Food Habits
Humans
Lactation
Lead - blood - pharmacokinetics
Milk, human - chemistry
Questionnaires
Research Support, Non-U.S. Gov't
Smoking - metabolism
Spectrophotometry, Atomic
Sweden
Abstract
Lead and cadmium levels were determined (with AAS) in blood and milk obtained at 6 weeks after delivery from women living in the vicinity of a copper and lead metal smelter and in a control area. Analysis of lead and cadmium were also performed in blood samples obtained at delivery. Accuracy of the analysis was confirmed by the analysis of quality control samples. In general, blood and milk levels of lead and cadmium were low in both areas. At 6 weeks after delivery the lead levels in blood and milk were 32 +/- 8 and 0.7 +/- 0.4 micrograms Pb/l, respectively (total mean +/- S.D., n = 75). Cadmium levels in blood and milk were 0.9 +/- 0.3 and 0.06 +/- 0.04 microgram Cd/l, respectively (n = 75). At delivery the lead levels in blood of women in the smelter area were higher, 38.7 micrograms Pb/l, than the blood lead levels in women from the control area, 32.3 micrograms Pb/l, (P
PubMed ID
7754354 View in PubMed
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Lipid kinase activity of antibodies from milk of clinically healthy human mothers.

https://arctichealth.org/en/permalink/ahliterature9167
Source
Biochim Biophys Acta. 2005 Aug 15;1735(3):153-66
Publication Type
Article
Date
Aug-15-2005
Author
Dmitrii V Gorbunov
Nataliya A Karataeva
Valentina N Buneva
Georgy A Nevinsky
Author Affiliation
Laboratory of Repair Enzymes, Siberian Division of Russian Academy of Sciences, Institute of Chemical Biology and Fundamental Medicine, Novosibirsk 630090, Russia.
Source
Biochim Biophys Acta. 2005 Aug 15;1735(3):153-66
Date
Aug-15-2005
Language
English
Publication Type
Article
Keywords
Adult
Chromatography, Affinity
Chromatography, Gel
Chromatography, Ion Exchange
Female
Humans
Immunoglobulin A - metabolism
Kinetics
Lactation
Lipid Metabolism
Milk, Human - chemistry - enzymology - immunology
N-Acetylneuraminic Acid
Phosphorylation
Phosphotransferases (Alcohol Group Acceptor) - immunology - metabolism
Research Support, Non-U.S. Gov't
Abstract
We have shown recently that polyclonal human milk sIgA contains a subfraction of antibodies (Abs) tightly bound to unusual minor milk lipids containing sialic acid. Here, we show that a small subfraction of milk IgG is tightly bound to the similar or the same minor lipids. The ability of small fractions of sIgA and IgG from human milk to phosphorylate selectively two minor lipids in the presence of [gamma-(32)P]nucleoside triphosphates was shown here for the first time to be an intrinsic property of these antibodies. In contrast to known kinases, antibodies with lipid kinase activity can transfer phosphoryl group to lipids not only from ATP but also from other different nucleotides (dATP, GTP, dGTP, UTP, TTP) with comparable efficiencies (30-100%). To our knowledge, there are no examples of enzymes using orthophosphate as a substrate of phosphorylation reactions. An extremely unusual property of lipid kinase Abs is their high affinity for orthophosphate (K(m)=1.6-5.6 microM) and capability to phosphorylate minor lipids using [(32)P]orthophosphate as donor of phosphate group. The relative specific activity and affinity of abzymes for orthophosphate and ATP depend significantly on donor milk. However, the levels of Ab-dependent phosphorylation of lipids for all Abs in the case of ATP (100%) and orthophosphate (60-80%) as substrates are comparable. The first example of natural abzymes with synthetic activity was milk sIgA with protein kinase activity. Most probably, lipid kinase sIgA and IgG of human milk are the second example of Abs with synthetic activity.
PubMed ID
16039903 View in PubMed
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The oral direct thrombin inhibitor, ximelagatran, an alternative for anticoagulant treatment during the puerperium and lactation.

https://arctichealth.org/en/permalink/ahliterature29756
Source
BJOG. 2005 May;112(5):579-83
Publication Type
Article
Date
May-2005
Author
M. Hellgren
S. Johansson
U G Eriksson
K. Wåhlander
Author Affiliation
Department of Antenatal Care, Primary Health Care South Bohuslän and Institute for the Health of Women and Children, Sahlgrenska Hospital/East, University of Göteborg, S-416 85 Göteborg, Sweden.
Source
BJOG. 2005 May;112(5):579-83
Date
May-2005
Language
English
Publication Type
Article
Keywords
Administration, Oral
Adult
Anticoagulants - administration & dosage - pharmacokinetics
Azetidines - administration & dosage - pharmacokinetics
Breast Feeding
Female
Glycine - analogs & derivatives - analysis - metabolism
Humans
Lactation
Milk, human - chemistry
Postpartum Period
Puerperal Disorders - prevention & control
Research Support, Non-U.S. Gov't
Thrombin - antagonists & inhibitors
Thromboembolism - prevention & control
Venous Thrombosis - prevention & control
Abstract
OBJECTIVE: To determine the excretion of the oral direct thrombin inhibitor (oral DTI), ximelagatran, and its active form, melagatran, in human milk, and to thus evaluate the potential exposure of breastfed infants to melagatran. DESIGN: An open, single dose, single centre study. SETTING: Department of Antenatal Care, Primary Health Care South Bohuslän and Institute for the Health of Women and Children, Göteborg University, Sweden. SAMPLE: Seven healthy Caucasian breastfeeding women who were at least two months postpartum were studied. METHODS: The concentrations of ximelagatran, its two intermediates, and melagatran were determined using liquid chromatography-mass spectrometry, with the limit of quantification of 2 nmol L(-1) for human milk and 10 nmol L(-1) for plasma concentrations. MAIN OUTCOME MEASURES: Concentrations of ximelagatran, its intermediates and melagatran were measured in breast milk over 72 hours, and in plasma over 12 hours, after a single oral 36 mg dose of ximelagatran. RESULTS: Neither ximelagatran nor its intermediates were detected in human breast milk. Only trace amounts of melagatran were detected. The mean cumulative amount of melagatran excreted into breast milk over the 72-hour period after dosing with oral ximelagatran was 0.00091% of the administered dose of ximelagatran. Ximelagatran was well tolerated, with no clinically relevant changes in laboratory variables or vital signs. CONCLUSIONS: Trace levels of melagatran are excreted in human breast milk following administration of the oral DTI ximelagatran. The exposure of breastfed infants to melagatran appears to be low and is therefore unlikely to be of clinical concern.
PubMed ID
15842280 View in PubMed
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