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Brownawell A.M.,Life science Research Organization | Carmines E.L.,Carmines Consulting LLC | Montesano F.,Chemi SpA
Food and Chemical Toxicology

α-Glycerylphosphorylcholine (AGPC) is a semi-synthetic derivative of lecithin. Following oral administration, it is converted to phosphatidylcholine, a metabolically active form of choline that is able to reach cholinergic synaptic endings where it increases acetylcholine synthesis and release. A series of studies were conducted to demonstrate the safety of AGPC. The oral LD50 was equal to or greater than 10,000. mg/kg in rats and mice. Deaths were preceded by convulsions in some animals. Dosing of dogs with up to 3000. mg/kg AGPC resulted only in reduced activity. Sub-chronic and chronic oral toxicity studies in rats (up to 1000. mg/kg/day) and beagles (up to 300. mg/kg/day) produced symptomology primarily consisting of reduced activity; slight decreases in food consumption and body weight gain; and slight reduction in liver weight, paralleled by significant decreases in plasma triglycerides, bilirubin, and alkaline phosphatase. There were no histopathological correlates. The in vivo and in vitro assays clearly indicated that AGPC was devoid of mutagenic activity. Based on these results, AGPC is not genotoxic in vitro or in vivo, exhibits low acute oral toxicity and, has an oral NOAEL of 150. mg/kg. bw/day following 26. weeks oral exposure. © 2011 Elsevier Ltd. Source

Brownawell A.M.,Life science Research Organization | Falk M.C.,Life science Research Organization
Nutrition Reviews

Current US guidelines for cholesterol recommend limiting intake of cholesterol to <300 mg/day for the general population and <200 mg/day for individuals with elevated low-density lipoprotein cholesterol. These recommendations, however, are at odds with international (e.g., Canada, United Kingdom, and Australia) guidelines that provide no specific numerical recommendation, but instead recommend reducing total fat intake and shifting fat consumption away from saturated and trans fats to unsaturated fats. A conference was held on December 3, 2008, to evaluate the data supporting current US nutrition policy recommendations to limit dietary cholesterol and analyze the consequences of this policy on the eating patterns and health of the US population. This review is a summary of the information and perspectives presented by conference speakers and discussed by conference participants. © 2010 International Life Sciences Institute. Source

Nigg J.T.,Oregon Health And Science University | Lewis K.,Life science Research Organization | Edinger T.,Oregon Health And Science University | Falk M.,Life science Research Organization
Journal of the American Academy of Child and Adolescent Psychiatry

The role of diet and of food colors in attention-deficit/hyperactivity disorder (ADHD) or its symptoms warrants updated quantitative meta-analysis, in light of recent divergent policy in Europe and the United States. Studies were identified through a literature search using the PubMed, Cochrane Library, and PsycNET databases through February 2011. Twenty-four publications met inclusion criteria for synthetic food colors; 10 additional studies informed analysis of dietary restriction. A random-effects meta-analytic model generated summary effect sizes. Restriction diets reduced ADHD symptoms at an effect of g = 0.29 (95% CI, 0.070.53). For food colors, parent reports yielded an effect size of g = 0.18 (95% CI, 0.080.24; p =.0007), which decreased to 0.12 (95% CI, 0.010.23; p <.05) after adjustment for possible publication bias. The effect was reliable in studies restricted to food color additives (g = 0.21, 95% CI = 0.060.36) but did not survive correction for possible publication bias and was not reliable in studies confined to Food and Drug Administrationapproved food colors. Teacher/observer reports yielded a nonsignificant effect of 0.07 (95% CI = -0.03 to 0.18; p =.14). However, high-quality studies confined to color additives yielded a reliable effect (g = 0.22, 95% CI = 0.100.41, p =.030) that survived correction. In psychometric tests of attention, the summary effect size was 0.27 (95% CI = 0.070.47; p =.007) and survived correction. An estimated 8% of children with ADHD may have symptoms related to synthetic food colors. A restriction diet benefits some children with ADHD. Effects of food colors were notable were but susceptible to publication bias or were derived from small, nongeneralizable samples. Renewed investigation of diet and ADHD is warranted. © 2012 American Academy of Child and Adolescent Psychiatry. Source

Del Gobbo L.C.,Tufts University | Falk M.C.,Life science Research Organization | Feldman R.,Life science Research Organization | Lewis K.,Life science Research Organization | Mozaffarian D.,Tufts University
American Journal of Clinical Nutrition

Background: The effects of nuts on major cardiovascular disease (CVD) risk factors, including dose-responses and potential heterogeneity by nut type or phytosterol content, are not well established. Objectives: We examined the effects of tree nuts (walnuts, pistachios, macadamia nuts, pecans, cashews, almonds, hazelnuts, and Brazil nuts) on blood lipids [total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein, and triglycerides], lipoproteins [apolipoprotein A1, apolipoprotein B (ApoB), and apolipoprotein B100], blood pressure, and inflammation (C-reactive protein) in adults aged $18 y without prevalent CVD. Design: We conducted a systematic review and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two investigators screened 1301 potentially eligible PubMed articles in duplicate. We calculated mean differences between nut intervention and control arms, dose-standardized to one 1-oz (28.4 g) serving/d, by using inverse-variance fixed-effects meta-analysis. Dose-response for nut intake was examined by using linear regression and fractional polynomial modeling. Heterogeneity by age, sex, background diet, baseline risk factors, nut type, disease condition, duration, and quality score was assessed with meta-regression. Publication bias was evaluated by using funnel plots and Egger's and Begg's tests. Results: Sixty-one trials met eligibility criteria (n = 2582). Interventions ranged from 3 to 26 wk. Nut intake (per serving/d) lowered total cholesterol (24.7 mg/dL; 95% CI: 25.3, 24.0 mg/dL), LDL cholesterol (24.8 mg/dL; 95% CI: 25.5, 24.2 mg/dL), ApoB (23.7 mg/dL; 95% CI: 25.2, 22.3 mg/dL), and triglycerides (22.2 mg/dL; 95% CI: 23.8, 20.5 mg/dL) with no statistically significant effects on other outcomes. The dose-response between nut intake and total cholesterol and LDL cholesterol was nonlinear (P-nonlinearity , 0.001 each); stronger effects were observed for $60 g nuts/d. Significant heterogeneity was not observed by nut type or other factors. For ApoB, stronger effects were observed in populations with type 2 diabetes (211.5 mg/dL; 95% CI: 216.2, 26.8 mg/dL) than in healthy populations (22.5 mg/dL; 95% CI: 24.7, 20.3 mg/dL) (P-heterogeneity = 0.015). Little evidence of publication bias was found. Conclusions: Tree nut intake lowers total cholesterol, LDL cholesterol, ApoB, and triglycerides. The major determinant of cholesterol lowering appears to be nut dose rather than nut type. Our findings also highlight the need for investigation of possible stronger effects at high nut doses and among diabetic populations. © 2015 American Society for Nutrition. Source

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