Tolerable upper intake levels for trans fat, saturated fat, and cholesterol

Tolerable upper intake levels (ULs) set by the Institute of Medicine (IOM) are important, in part because they are used for estimating the percentage of the population at potential risk of adverse effects from excessive nutrient intake. The IOM did not set ULs for trans fat, saturated fat, and cholesterol because any intake level above 0% of energy increased LDL cholesterol concentration and these three food components are unavoidable in ordinary diets. The purpose of the analysis presented in this review was to evaluate clinical trial and prospective observational data that were not previously considered for setting a UL with the aim of determining whether the current UL model could be used for saturated fat, trans fat, and cholesterol. The results of this analysis confirm the limitations of the risk assessment model for setting ULs because of its inability to identify a UL for food components, such as cholesterol, that lack an intake threshold associated with increased chronic disease risk.     

A critical assessment of the upper intake levels for infants and children

The dietary reference intake (DRI) committees of the Food and Nutrition Board of the Institute of Medicine were charged with establishing DRIs for all of the essential nutrients, including fat and energy. These reference values are quantitative estimates of the nutrient intakes to be used to plan and assess the diets of healthy people. The reference values include both recommended intakes and tolerable upper intake levels (ULs). The ULs are defined as "the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population." As intake increases above the UL, the risk of adverse effects increases. The term "tolerable intake" was chosen to avoid the implication of a possible beneficial effect. Instead, the term is intended to connote a level of intake that can, with a high probability, be tolerated biologically. Yet, with intakes above the ULs, the risk of adverse health effects increases. Thus, there is no obvious benefit for healthy individuals to consume quantities of nutrients above the UL.     

Appropriate calcium fortification of the food supply presents a challenge

Fortification with calcium to increase dietary intakes of this mineral is currently under evaluation in Canada. To model the potential dietary consequences of food fortification, data from a large national survey of Canadians (n = 1543) were used. Food fortification scenarios were based on reference amounts for labeling requirements. Consumption of milk, cheese and other dairy products was associated with high calcium intakes, and there was a low prevalence of inadequacy in men < 50 y old; however, other age-sex groups had lower intakes. The aim of the fortification modeling was to determine which scenario would most effectively reduce the proportion of the population with low intakes of calcium while minimizing the proportion of individuals who exceeded the tolerable upper intake level (UL). Given the correlation between energy and calcium (r = 0.60, P < 0.01), it appeared that any fortification scenario sufficient to increase the mean intake for women to near the adequate intake led to 6-7% of the men having calcium intakes above the UL. The results suggest that fortification of widely consumed foods is not a realistic way to address the issue of low calcium intakes and illustrate the need for concern about the growing use of fortification practices.     

Vitamine und Mineralstoffe in Nahrungsergänzungsmitteln

The Federal Institute of Risk Assessment (BfR) has applied principles of scientific risk assessment to derive proposals for maximum levels of vitamins and minerals including trace elements in food supplements and fortified food products. This review describes the special features pertaining to the risk assessment of these essential micronutrients and the procedure used for the derivation of maximum levels for individual food supplements. The applied procedure takes into account tolerable upper intake levels (UL), intakes of vitamins and minerals in normal daily diets and dietary reference values for the derivation of maximum levels in individual food products. In this context, consideration must be given to the possibility of multiple exposure via daily intakes of several food supplements or several fortified food products. A careful risk-benefit analysis was necessary because, with nutrients having a narrow margin of safety, the need to compensate for possibly inadequate intakes or increased demands had to be weighed against the risk of excessive intakes. With nutrients where no UL could be derived due to inadequate databases, the BfR recommends that maximum levels should be set on the basis of nutritional-physiological aspects. It should be noted that this recommendation is based on reasons of preventive health protection.     

Gap analysis guidelines for assessing acute, chronic, and lifetime exposures to high levels of various nutrients

Twenty-two tolerable upper intake levels (ULs) have been established using data available from research with both humans and animals. No ULs were established for another 10 nutrients for which the existing data were evaluated. Gaps in knowledge on the adverse health effects that may arise as a result of acute, chronic, and lifetime exposures to high levels of many of these nutrients remain. The existence of a UL for a nutrient is not an indication that no gaps in the desired information exist, nor does the absence of a UL suggest that no risk of adverse health effects exists for very high levels of nutrient intake. Finally, it is important to keep in mind the definition of a UL. It is "the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects for almost all individuals in the general population." There are many gaps in knowledge about the levels at which several nutrients cause adverse health effects. As these gaps are filled, the values for ULs will be adjusted as appropriate.     

Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands

Background In 2004, the European Court of Justice decided that the prohibition of fortification with vitamin A, vitamin D, folic acid, selenium, copper, and zinc in the Netherlands conflicts with the principle of free movement of goods in the European Union. This decision led to a change in the Dutch policy, resulting in a more flexible handling of requests for exemption from this prohibition to fortify. Therefore, an investigation was proposed in which it would be determined whether a general exemption could be granted for food fortification with a certain maximum safe amount per micronutrient. Aim of the study To develop a risk assessment model to estimate maximum safe fortification levels (MSFLs) of vitamins and minerals to foods on the Dutch market, and to evaluate these levels to derive allowed fortification levels (AFLs), which can be used for a general exemption. Methods We developed a risk assessment model to estimate MSFLs of vitamins and minerals to foods on the basis of existing models. We used European tolerable upper intake levels in combination with national food consumption data to estimate MSFLs for fortification of foods for several age groups. Upon extensive stakeholder dialogue, the risk manager considered these estimated MSFLs and the final AFLs for a general exemption were set. Results For folic acid, vitamin A, and vitamin D, the MSFLs were calculated in the risk-assessment model. Children up to 6-years old were the group most sensitive to folic acid fortification, and they had an MSFL of 0 μg/100 kcal, but following a risk management evaluation, this was upgraded to an AFL of 100 μg/100 kcal. The MSFL for vitamin D was 3.0 μg/100 kcal (children 4–10 years old), and the risk manager increased this to an AFL of 4.5 μg/100 kcal. Children up to 10 years old, men, and postmenopausal women were the groups most sensitive to vitamin A fortification (MSFL = 0 μg/100 kcal). Because these groups represent a large part of the population and because of the seriously harmful effects of excessive vitamin A, the risk manager did not allow a general exemption. Conclusions The combination of a risk assessment model and risk manager evaluation led to the setting of AFLs for general exemption of fortification with folic acid and vitamin D. This model is also applicable for other micronutrients, for which an UL is derived, and in other countries.     

Changes in Dietary Guidance: Implications for Food and Nutrient Databases

Two types of dietary guidance for Americans have recently been released, and both have important implications for the way data are organized on food and nutrient databases. New dietary reference intakes (DRIs) have been set for 17 nutrients, and in several cases the units for these recommendations do not match those traditionally carried on nutrient databases. Furthermore, some of the tolerable upper intake levels (ULs) are specified only for supplemental and fortification forms of nutrients, which necessitates calculating separate intake values for nutrients from foods and nutrients that are added to foods or taken as supplements. The year 2000 revision of the Dietary Guidelines for Americans also suggest new ways to evaluate dietary intakes: there is an increased emphasis on obtaining an appropriate number of servings from food groups such as fruits, vegetables, whole grains, and lowfat dairy products. To allow users of nutrient databases to provide relevant evaluations of dietary data, developers will need to consider carrying a much larger array of variables in order to calculate intakes of folate in folate equivalents, vitamin E as alpha-tocopherol (not as alpha-tocopherol equivalents), nutrients occurring in foods versus added or supplemental nutrients, and the number of servings from a variety of food groups.

• •For more information on the DRIs, see:.
• •For more information on the year 2000 Dietary Guidelines, see:

     

Development of a model for optimal food fortification: vitamin D among adults in Finland

Background Average vitamin D intake is low in Finland. Even though almost all retail milk and margarine are fortified with vitamin D, the vitamin D intake is inadequate for a significant proportion of the population. Consequently, expanded food fortification with vitamin D would be motivated. However, there is a risk of unacceptably high intakes due to the rather narrow range of the adequate and safe intake. Therefore, a safe and efficient food fortification practice should be found for vitamin D. Aim of the study To develop a model for optimal food fortification and apply it to vitamin D. Method The FINDIET 2002 Study (48-h recall and data on supplement use (n = 2007), and 3 + 3 days’ food records, n = 247) was used as the test data. The proportion of the population whose vitamin D intake is between the recommended intake (RI) and the upper tolerable intake level (UL) was plotted against the fortification level per energy for selected foods. The fortification level that maximized the proportion of the population falling between RI and UL was considered the optimal fortification level. Results If only milk, butter milk, yoghurt and margarine were fortified, it would be impossible to find a fortification level by which the intake of the whole population would lie within the RI-UL range. However, if all potentially fortifiable foods were fortified with vitamin D at level 1.2–1.5 μg/100 kcal, the intake of the whole adult population would be between the currently recommended intake of 7.5 μg/d and the current tolerable upper intake level of 50 μg/day (model 1). If the RI was set to 40 μg/day and UL to 250 μg/day, the optimal fortification level would be 9.2 μg/100 kcal in the scenario where all potentially fortifiable foods were fortified (model 2). Also in this model the whole population would fall between the RI-UL range. Conclusions Our model of adding a specific level of vitamin D/100 kcal to all potentially fortifiable foods (1.2–1.5 μg/100 kcal in model 1 and 9.2 μg/100 kcal in model 2) seems to be an efficient and safe food fortification practise.     

维生素矿物质可耐受最高摄入量的研究进展

根据美国医学科学院的食品营养委员会 (FNB) ,英国MAFF的安全专家组和欧洲的食品科学委员会研究维生素矿物质摄入的安全性的结果 ,综述了制定可耐受最高摄入量 (ULs)的依据 (危害因子确认 ,剂量-反应评估和不确定因素 ) ,对比了中美两国主要维生素矿物质的ULs,并阐述了对维生素A、D、钙、铜、碘、磷、硒、铁、钒ULs的新认识。     

Fortification masks nutrient dilution due to added sugars in the diet of children and adolescents

High intakes of added sugars have often been suspected of lowering nutrient density, especially in the diet of children and adolescents. Because fortified foods, which currently contribute considerably to the intake of vitamins and minerals, are often also sweetened with added sugars, they could counteract this nutrient dilution. Data from the DOrtmund Nutritional and Anthropometric Longitudinally Designed (DONALD)-Study were used to assess the effects of added sugars, fortified food and energy intakes, time and age on nutrient densities. A total of 4993 3-d weighed dietary records from 849 children and adolescents 2-18 y old, collected between 1985 and 2001 were analyzed using a mixed linear model, in which the means of the data and the covariance structure specific to the DONALD-Study was modeled. In general, nutrient densities in the diets of children and adolescents were above recommended nutrient densities. Added sugars intake [in percentage of energy intake (E%)] was positively associated with energy intake (MJ/d; P < 0.05) and intake of fortified food (E%; P < 0.0001). Positive effects of fortification on nutrient densities (usually P < 0.0001) exceeded the negative effects of added sugars intake (usually P < 0.01) for most nutrients, in some cases even twofold. Associations between energy intake and nutrient densities were negative and, with the exception of thiamin in 2- to 3-y-olds, statistically significant. Time and age trends were heterogeneous. Our data did not show significant nutrient dilution because of added sugars. The positive effect of fortification on nutrient densities was greater than the negative effect of added sugars. Therefore, fortification should more often be considered in dietary analyses.     

Consumption of energy-dense, nutrient-poor foods by adult Americans: nutritional and health implications. The third National Health and Nutrition Examination Survey, 1988-1994

BACKGROUND: Current dietary guidance recommends limiting the intake of energy-dense, nutrient-poor (EDNP) foods, but little is known about recent consumption patterns of these foods. OBJECTIVE: The contribution of EDNP foods to the American diet and the associated nutritional and health implications were examined. DESIGN: Data from the third National Health and Nutrition Examination Survey (n = 15611; age >/=20 y) were used. EDNP categories included visible fats, nutritive sweeteners and sweetened beverages, desserts, and snacks. The potential independent associations of EDNP food intake with intakes of energy, macronutrients, micronutrients, and serum vitamin, lipid, and carotenoid profiles were examined with linear and logistic regression procedures. RESULTS: EDNP foods supplied approximately 27% of energy intake; alcohol provided an additional 4%. The relative odds of consuming foods from all 5 food groups and of meeting the recommended dietary allowance or daily reference intake for protein and several micronutrients decreased with increasing EDNP food intake (P: < 0.0001). Energy intake and percentage of energy from fat were positively related to EDNP intake. Serum concentrations of vitamins A, E, C, and B-12; folate; several carotenoids; and HDL cholesterol were inversely related (P: 相似文献   

Vitamin D intake of Dutch infants from the combination of (fortified) foods,infant formula,and dietary supplements

Purpose

Due to changes in the Dutch fortification policy for vitamin D and the vitamin D supplementation advice for infants (10-μg/d for 0–4 year olds), a partially virtual scenario study was conducted to evaluate the risk of excessive vitamin D intake assigning all infants to a 100 % adherence to the supplementation advice and considering the current fortification practice.

Methods

Food consumption data from the Nutrition Intake Study (2002; N = 941, 7–19 months) were combined with Dutch food composition data from 2011 to estimate vitamin D intake from (fortified) foods. For infants 0–6 months of age, the consumption volume infant formula was estimated from energy requirement and body weight. All subjects were assigned to take a daily 10 µg vitamin D supplement, according the Dutch supplementation advice for infants. Habitual vitamin D intake was estimated using the Statistical Program to Assess Dietary Exposure and compared with the tolerable upper intake levels (ULs) set by the European Food Safety Authority.

Results

The median habitual total vitamin D intake was 16–22 µg/day for infants aged 0–6 months (increasing with age) and 13–21 µg/day for infants aged 7–19 months (decreasing with age). About 4–12 % of infants aged 7–11 months exceeded the UL. At the 99th percentile, the intake was 2–4 µg above the UL, depending on age. Infants aged 0–6 and 12–19 months did not exceed the UL.

Conclusions

In case of combined intake from infant formula, (fortified) foods, and supplements, vitamin D intakes above the UL are possible among some infants during a limited time period.

     

The effect of a moderate increase in dietary fibre on the nutrient intake of 15 young women

Fifteen young women increased the fibre content of their diet from 19 g/d to 40 g/d for a period of 10 weeks using conventional food sources. They weighed and recorded all their food and drink intake. There was no change in energy intake, but the proportion of energy derived from fat fell from 40 to 34%. The intake of nearly all the vitamins and minerals increased. It was concluded that a moderate increase in dietary fibre has positive nutritional consequences for the whole diet.     

Foods, fortificants, and supplements: Where do Americans get their nutrients?

Limited data are available on the source of usual nutrient intakes in the United States. This analysis aimed to assess contributions of micronutrients to usual intakes derived from all sources (naturally occurring, fortified and enriched, and dietary supplements) and to compare usual intakes to the Dietary Reference Intake for U.S. residents aged ≥2 y according to NHANES 2003-2006 (n = 16,110). We used the National Cancer Institute method to assess usual intakes of 19 micronutrients by source. Only a small percentage of the population had total usual intakes (from dietary intakes and supplements) below the estimated average requirement (EAR) for the following: vitamin B-6 (8%), folate (8%), zinc (8%), thiamin, riboflavin, niacin, vitamin B-12, phosphorus, iron, copper, and selenium (<6% for all). However, more of the population had total usual intakes below the EAR for vitamins A, C, D, and E (34, 25, 70, and 60%, respectively), calcium (38%), and magnesium (45%). Only 3 and 35% had total usual intakes of potassium and vitamin K, respectively, greater than the adequate intake. Enrichment and/or fortification largely contributed to intakes of vitamins A, C, and D, thiamin, iron, and folate. Dietary supplements further reduced the percentage of the population consuming less than the EAR for all nutrients. The percentage of the population with total intakes greater than the tolerable upper intake level (UL) was very low for most nutrients, whereas 10.3 and 8.4% of the population had intakes greater than the UL for niacin and zinc, respectively. Without enrichment and/or fortification and supplementation, many Americans did not achieve the recommended micronutrient intake levels set forth in the Dietary Reference Intake.     

The impact of voluntary fortification of foods on micronutrient intakes in Irish adults

The objective of this work was to quantify the impact of the voluntary fortification of foods on dietary intakes of vitamins and minerals of Irish adults. Foods that were voluntarily fortified were identified and pre- and post-fortification levels of micronutrients were determined from data supplied by manufacturers and food composition tables. Using food consumption data in 1379 adults aged 18-64 years, estimated using a 7-d food diary during the North/South Ireland Food Consumption Survey, intakes of micronutrients were determined, both including and excluding the fortification component in foods. Of approximately 3000 foods recorded as consumed, 1.9 % were fortified, mainly breakfast cereals and beverages. Median micronutrient content of fortified foods (FF) ranged from 18-33 % EC RDA per typical serving. Among consumers (65 % of men, 68 % of women), FF contributed, on average, 3.9 % (men) and 5.0 % (women) to mean daily intake (MDI) of energy. Relative to their contribution to MDI of energy, FF contribute a greater % MDI for Fe (men 16, women 19), folate (men 18, women 21), vitamins B1 (men 14, women 16), B2 (men 16, women 18), B6 (men 12, women 15), D (men 5, women 11), B12 (men 5, women 7) and niacin (men 10, women 12). Fortification significantly improved the adequacy of intake of some micronutrients, particularly of riboflavin, folate, vitamin D and Fe in women and did not contribute to an increased risk of adverse effects from excessive intake of any micronutrient.     

Ten-year trends in vitamin and mineral intake from fortified food in German children and adolescents

OBJECTIVE: We investigated time trends in consumption patterns, and energy and nutrient intakes (protein, fat, carbohydrates, added sugars, vitamins A, E, C, B1, B2 and B6, niacin, folate, calcium and iron) from fortified food in children and adolescents between 1987 and 1996 in Germany. DESIGN: Mixed longitudinal survey (DONALD study) with 3 d weighed dietary records (n=2062 from 594 subjects), one subject per family per year chosen by random. SETTING: Dortmund (Western Germany) district cohort. SUBJECTS: 285 males, 309 females; mean age 6 y (2-13 y). RESULTS: Almost all children and adolescents consumed fortified food irrespective of the year studied. With the exception of vitamin E, significant time trends in the proportions of nutrient intakes from fortification were observed. The fortification of food with vitamins A, C, B1, B2 and B6 and niacin raised the already adequate intakes from non-fortified food (100% to 150% of reference intake values) by 20-50%. The fortification of food with vitamin E and folate raised the low intakes from non-fortified food (about 50% of reference intake values) to about 80% (folate) and 100% (vitamin E) of the references. Fortification of food with calcium and iron was not significant (<10%), but while total intake of calcium was adequate, total intake of iron remained critical. CONCLUSIONS: Since the nutrient intake of the population of children and adolescents studied is adequate with respect to vitamins A, C, B1, B2 and B6, niacin and calcium, fortification seems inefficient, while fortification of food with vitamin E and folate, but not iron, improves an inadequate intake. SPONSORSHIP: The DONALD study is supported by the German Federal Ministry of Health and the North-Rhine-Westphalian Ministry of Science and Research. European Journal of Clinical Nutrition (2000) 54, 81-86     

Reconsidering the Tolerable Upper Levels of Zinc Intake among Infants and Young Children: A Systematic Review of the Available Evidence

Safe upper levels (UL) of zinc intake for children were established based on either (1) limited data from just one study among children or (2) extrapolations from studies in adults. Resulting ULs are less than amounts of zinc consumed by children in many studies that reported benefits of zinc interventions, and usual dietary zinc intakes often exceed the UL, with no apparent adverse effects. Therefore, existing ULs may be too low. We conducted a systematic bibliographic review of studies among preadolescent children, in which (1) additional zinc was provided vs. no additional zinc provided, and (2) the effect of zinc on serum or plasma copper, ceruloplasmin, ferritin, transferrin receptor, lipids, or hemoglobin or erythrocyte super-oxide dismutase were assessed. We extracted data from 44 relevant studies with 141 comparisons. Meta-analyses found no significant overall effect of providing additional zinc, except for a significant negative effect on ferritin (p = 0.001), albeit not consistent in relation to the zinc dose. Interpretation is complicated by the significant heterogeneity of results and uncertainties regarding the physiological and clinical significance of outcomes. Current zinc ULs should be reassessed and potentially revised using data now available for preadolescent children and considering challenges regarding interpretation of results.     

Vitamins and minerals: A model for safe addition to foods

BACKGROUND: Significant subgroups in most European populations have intakes below nationally recommended levels for several vitamins, minerals and trace elements, placing individuals at risk of suboptimal intake of important vitamins and minerals. The voluntary addition of micronutrients to the appropriate foods may help address the risks associated with low micronutrient intakes. However, concerns need to be addressed regarding the potential for unacceptably high intakes, particularly for those people consuming very large amounts of food. AIM OF THE STUDY: To develop a model to estimate the level of each micronutrient that can be added safely to foods. METHODS: A theoretical model was developed based on the critical factors which determine the risk of unacceptably high intake for each micronutrient at high levels of food/energy intakes. These included 1) Tolerable Upper Intake Levels (UL), 2) high micronutrient intakes in Europe at the 95(th) percentile intake for each nutrient, 3) the proportion of fortified foods in the diets of individuals at the 95(th) percentile for energy intakes, 4) the proportion of foods to which micronutrients could practically be added, and 5) a range of estimates for the fractions of foods which might be actually fortified for each nutrient. A maximum level was set up for each micronutrient per typical serving or 100 kcal portion. The outputs of the model were then compared against a recent model developed by AFSSA, based on the food intake data in France. RESULTS: Three categories of micronutrients were identified, in which micronutrients could be added safely to foods at levels (per serving, e. g., 100 kcal) 1) greater than 1 European Commission Recommended Daily Intake (EC RDA): vitamin B12, vitamin C, vitamin E, riboflavin, panthothenic acid, niacin and thiamine; 2) between 50 and 100 % of the EC RDA: vitamin B6, vitamin D, folic acid, biotin, copper, iodine and selenium; 3) between 10 and 40 % of the EC RDA: iron, zinc, calcium, phosphorus and magnesium. A fourth category consisting of retinol, for which high end intake levels are close to UL for some population subgroups in Europe and thus requires further consideration. CONCLUSIONS: A wide range of vitamins and minerals can be added safely to foods at nutritionally important levels in the current diets of Europeans.     

Vitamin intake of 3- to 36-month-old German infants and children--results of the DONALD-Study.

Infants and young children are a vulnerable group with regard to nutrition. However, there is a lack of information about the dietary composition of healthy German infants and children. Therefore, the intake of vitamins (A, C, E, B1, B2, B6, folate, niacin) was assessed in 354 healthy German infants and children aged 3 to 36 months from 3-day-weighed diet records and compared with German, European and US reference values. Intake of all B-vitamins (B1, B2, B6, folate, niacin) increased during the first 3 years of life, whereas intake of vitamin E decreased. Intake of vitamin A and C varied between age groups. The highest levels of the nutrient densities of most vitamins were found at the end of the first year of life. Depending on the reference values chosen, the vitamin supply of the study population ranged between sufficient and very good. The reported satisfactory intake of vitamins in infants and young children in this study gives rise to the question of whether the current extent of fortification of commercial infant food in Germany is necessary.