A systematic review of published toxicology and human intervention studies was performed to characterize potential hazards associated with consumption of green tea and its preparations. A review of toxicological evidence from laboratory studies revealed the liver as the target organ and hepatotoxicity as the critical effect, which was strongly associated with certain dosing conditions (e.g. bolus dose via gavage, fasting), and positively correlated with total catechin and epigallocatechingallate (EGCG) content. A review of adverse event (AE) data from 159 human intervention studies yielded findings consistent with toxicological evidence in that a limited range of concentrated, catechin-rich green tea preparations resulted in hepatic AEs in a dose-dependent manner when ingested in large bolus doses, but not when consumed as brewed tea or extracts in beverages or as part of food. Toxico- and pharmacokinetic evidence further suggests internal dose of catechins is a key determinant in the occurrence and severity of hepatotoxicity. A safe intake level of 338 mg EGCG/day for adults was derived from toxicological and human safety data for tea preparations ingested as a solid bolus dose. An Observed Safe Level (OSL) of 704 mg EGCG/day might be considered for tea preparations in beverage form based on human AE data.

Objective The study compared the 7-point Subjective Global Assessment (SGA) and the Protein Energy Wasting (PEW) Score with Nutrition Evaluations (NutrE) conducted by registered dietitian nutritionists (RDNs) in identifying PEW risk in stage five chronic kidney disease (CKD) patients on maintenance hemodialysis (MHD). Design and Methods This study is a secondary analysis of a cross-sectional study entitled “Development and Validation of a Predictive energy Equation in Hemodialysis”. PEW risk identified by the 7-point SGA and the PEW Score were compared against the NutrE conducted by RDNs through data examination from the original study (reference standard). Subjects A total of 133 patients were included for the analysis. Main Outcome Measures The sensitivity, specificity, positive and negative predictive value (PPV and NPV), positive and negative likelihood ratio (PLR and NLR) of both scoring tools were calculated when compared against the reference standard. Results The patients were predominately African American (n=112, 84.2%), non-Hispanic (n=101, 75.9%), and male (n=80, 60.2%). Both the 7-point SGA (sensitivity =78.6%, specificity = 59.1%, PPV = 33.9%, NPV = 91.2%, PLR = 1.9 and NLR = 0.4) and the PEW Score (sensitivity = 100%, specificity= 28.6%, PPV = 27.2%, NPV = 100%, PLR = 1.4 and NLR = 0) were more sensitive than specific in identifying PEW risk. The 7-point SGA may miss 21.4% patients having PEW and falsely identify 40.9% of patients who do not have PEW. The PEW Score can identify PEW risk in all patients but 71.4% of patients identified may not have PEW risk. Conclusions Both the 7-point SGA and the PEW Score could identify PEW risk. The 7-point SGA was more specific and the PEW Score was more sensitive. Both scoring tools were found to be clinically confident in identifying patients who were actually not at PEW risk.

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Objectives To develop a modified Nutrition Rich Food Index (PS-NRF) to assess the nutrient density (ND) of protein snack foods, based on the nutritional profile of most commonly consumed protein-rich food items, which can be used to develop nutrient-dense protein snacks. Methods Good source protein food items, defined as ready-to-eat food items with ≥10% of the US protein daily value (DV), were selected from the 450 most frequently consumed food items by the NHANES 2013–14 participants aged ≥2y. Principal component analysis (PCA) was conducted on the 7 encouraged micronutrients in the original NRF 9.3 calculation (vitamins A, C, D, calcium, iron, potassium and magnesium) to determine which would be appropriate for the PS-NRF. PS-NRF was calculated by subtracting the sum of percentages of maximum recommended values for discouraged nutrients (saturated fat, total sugar and sodium) from the sum of percentages of DVs for encouraged nutrients (protein, fiber and select micronutrients from this study), capped at 100% per DV. In order to use healthy food options as the basis, only positive PS-NRF/100 kcal values were used to calculate the mean, median, and inter-quartile range (IQR) of the good protein source food items and target those items with accompanying nutrient(s) to encourage. Results One hundred and sixty-nine good source protein food items were identified (17.16% Milk and Milk Products, 29% Meat, Poultry, Fish and mixtures, 23.67% Eggs, 21.3% Legumes, nuts and seeds, and 8.88% grain products). According to the PCA, vitamin A (r = −0.61), vitamin D (r = −0.49), and calcium (r = −0.53) had relatively stronger strengths of correlation compared to other micronutrients and therefore included in the PS-NRF. Based on this approach, 127 (75.15%) good source protein food items were found to have positive PS-NRF. The mean ± SD and median (IQR) of the PS-NRF/100 kcal index were: 12.23 ± 10.95 and 10.22 (4.72 to 16.35). Conclusions This study demonstrated that in good source protein food items, vitamins A, D and calcium were found to be accompanying nutrients that were influential contributors to the DVs and were included as encouraged micronutrients in the PS-NRF. The mean PS-NRF among all good source protein food items with positive PS-NRF was 12.23/100 kcal, which could be used as a reference to differentiate healthy protein snack foods with good nutrient density. Funding Sources None.

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Objectives The objective of this study is to measure the nutrient density (ND) of the 7-day sample menus for a 2000 calorie meal plan recommended by the United States Department of Agriculture (USDA) using the Nutrition Rich Food (NRF) index and to determine target NRF index score for a meal and a day. Methods Each food item on the menu was represented by the representative most frequently consumed food item from the National Health and Nutrition Examination Survey (NHANES) 2013–2014. Nutrition information was extracted from the USDA database according to the food code of each food item. Nutrient density was evaluated by calculating the NRF index for individual meals (breakfast, lunch, and dinner), snacks and overall daily intake based on previously published method. The mean, median, and interquartile range (IQR) of the NRF index for the meals, snacks and daily intake over 7 days were calculated. One-sample t-test was conducted to compare the estimated mean daily intakes of individual nutrients derived from present analysis to the reported values by USDA. Results The mean ± SD and median (IQR) of the NRF index of all meals were: 209 ± 83.7 and 199.6 (158.6 to 229.1). For each eating occasion, the mean ± SD and median (IQR) of the NRF index of breakfast, lunch and dinner meals, and snacks were 184.2 ± 65.5 and 195.7 (174.4 to 223.5), 213.5 ± 72.5 and 205.4 (169.2 to 229.7), 229.2 ± 112.3 and 186.7 (164.6 to 254.4), and 55.9 ± 36.6 and 47.4 (33.3 to 80.9), respectively. The mean ± SD and median (IQR) of the NRF index of daily intake over 7 days were 457.4 ± 61.7 and 455.5 (424.4 to 471.2). The estimated mean daily intake levels of sodium was found significantly higher than the mean daily intake level reported by the USDA (t = 3.57, P = 0.012). Conclusions The study demonstrated that ND varies among the meals and daily intake following the USDA 7-day meal plan, and breakfast meals appear to have lower ND relative to lunch and dinner. Overall ND of daily intake was 457.4 ± 61.7 as presented by NRF index, which can be used as a reference score to evaluate the healthfulness of daily intake. However, by following our methodology, the USDA meal plan may have underestimated the daily intake of sodium. Since nutrient profile and content can vary significantly among foods within the same food group, foods with high ND should be selected to help meet nutrient needs while adhering to a healthy eating pattern. Funding Sources No funding source for the research. All authors are full time employees of Herbalife Nutrition.