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Iodine-based mouthwash and throat sprays contain povidone iodine (PVP-I) for disinfection. PVP-I mouthwash has been commonly used for decades in Japan and other countries and frequent and/or prolonged use of PVP-I mouthwash can induce transient hypothyroidism. To assess the amount of iodine ingested from an oral rinse, 22 healthy adult volunteers (mean age: 48.1, 29–70 years) were recruited for the study. The subjects were instructed to rinse for 15 s three times with 20 mL of commercially available PVP-I mouthwash diluted into 0.23% or pure water. This method is a standardized method of gargling recommended by the manufacturers. The total iodine in the PVP-I mouthwash was measured with inductively coupled plasma-mass spectrometry. Although the 7% PVP-I mouthwash contains 7 mg of effective iodine/mL, 24.3 mg/mL of iodine was detected in the solution. The median value and ratio of the total iodine ingested were 5.0 mg (range: 2.6–10.8 mg) and 20.5% (range: 10.6–44.5%), respectively. The iodine species released from the PVP-I mouthwash are effective iodine (PVP・nHI3, I3−, and I2) and I−; however, the amount and types of iodine actually absorbed into the bloodstream are unknown. PVP-I mouthwash should be used carefully since around 5 mg of iodine could theoretically enter the body with one gargle which exceeds the tolerable upper intake level of iodine for adults. This study was prospectively registered to University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) on March 29, 2021, with the study ID of UMIN000043770.

BackgroundDietary supplements (DS) are largely consumed in Western countries without demonstrating their nutritional benefits and safety in the general population. The aims, in a large population-based study of French adults, were: (1) to compare the prevalence of nutrient intake inadequacy and the proportion of individuals exceeding tolerable upper intake levels (UL) between DS users and non-users, and (2) to quantify the extent of potentially “at-risk” DS use practices (e.g., DS/drugs contraindicated association or use of beta-carotene DS in smokers).Methods76,925 participants, 47.6% men and 52.4% women, mean age 46.9 ± 16.3 years were enrolled to the NutriNet-Santé cohort and they completed a quantitative DS questionnaire and three 24 h dietary records. A composition database including > 8000 DS was developed. Variance reduction was applied to estimate usual intakes and analyses were weighted according to the French census data.ResultsAmong DS users of the specific nutrient, DS contributed to 41% of total intake for vitamin D in men, 55% in women; and to 20% of total intake for pyridoxine in men, 21% in women. Compared to dietary intakes only, their prevalence of inadequacy was reduced by 11% for vitamin C, 9% for magnesium, 6% for pyridoxine in men, and 19% for calcium, 12% for iron, and 11% for magnesium in women (p < 0.0001). The proportion of subjects exceeding UL reached 6% for iron and 5% for magnesium in men, and 9% for iron in women. 6% of DS users had potentially “at-risk” practices.ConclusionWhile DS use contributed to decrease the prevalence of insufficient intake for several nutrients, it also conveyed excessive intake of iron and magnesium. Besides, a substantial proportion of potentially “at-risk” DS use practices was reported.

Micronutrients play a pivotal role in achieving and maintaining optimum health across all life stages. Much of the U.S. population fails to meet Estimated Average Requirements (EARs) for key nutrients. This analysis aims to assess the contribution of fortified ready-to-eat cereals (RTEC) to micronutrient intake for U.S. residents aged 2–18, 19–99, and 2–99 years of age according to National Health and Nutrition Examination Survey (NHANES) 2007–2010 data. We used the National Cancer Institute (NCI) method to assess usual intake of 21 micronutrients and the percentage of the population under EARs and above Tolerable Upper Intake Levels (UL). Without fortification of RTECs, the percentage of those aged 2–18 years that were below EARs increased by 155, 163, 113, and 35% for niacin, iron, thiamin, and vitamin A, respectively. For vitamins B6 and zinc, the respective numbers were 118% and 60%. Adults aged 19–99 and 2–99 had lower percentages but similar outcomes. RTECs are associated with improved nutrient adequacy and do not widely affect prevalence above the UL. The data indicate that large proportions of the population fail to achieve micronutrient sufficiency without fortification, and that its use can help Americans reach national nutrient intake goals.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for selenium. Systematic reviews of the literature were conducted to identify evidence regarding excess selenium intake and clinical effects and potential biomarkers of effect, risk of chronic diseases and impaired neuropsychological development in humans. Alopecia, as an early observable feature and a well‐established adverse effect of excess selenium exposure, is selected as the critical endpoint on which to base a UL for selenium. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 330 μg/day is identified from a large randomised controlled trial in humans (the Selenium and Vitamin E Cancer Prevention Trial (SELECT)), to which an uncertainty factor of 1.3 is applied. A UL of 255 μg/day is established for adult men and women (including pregnant and lactating women). ULs for children are derived from the UL for adults using allometric scaling (body weight0.75). Based on available intake data, adult consumers are unlikely to exceed the UL, except for regular users of food supplements containing high daily doses of selenium or regular consumers of Brazil nuts. No risk has been reported with the current levels of selenium intake in European countries from food (excluding food supplements) in toddlers and children, and selenium intake arising from the natural content of foods does not raise reasons for concern. Selenium‐containing supplements in toddlers and children should be used with caution, based on individual needs.

Following a request from five European Nordic countries, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was tasked to provide scientific advice on a tolerable upper intake level (UL) or a safe level of intake for dietary (total/added/free) sugars based on available data on chronic metabolic diseases, pregnancy‐related endpoints and dental caries. Specific sugar types (fructose) and sources of sugars were also addressed. The intake of dietary sugars is a well‐established hazard in relation to dental caries in humans. Based on a systematic review of the literature, prospective cohort studies do not support a positive relationship between the intake of dietary sugars, in isocaloric exchange with other macronutrients, and any of the chronic metabolic diseases or pregnancy‐related endpoints assessed. Based on randomised control trials on surrogate disease endpoints, there is evidence for a positive and causal relationship between the intake of added/free sugars and risk of some chronic metabolic diseases: The level of certainty is moderate for obesity and dyslipidaemia (> 50–75% probability), low for non‐alcoholic fatty liver disease and type 2 diabetes (> 15–50% probability) and very low for hypertension (0–15% probability). Health effects of added vs. free sugars could not be compared. A level of sugars intake at which the risk of dental caries/chronic metabolic diseases is not increased could not be identified over the range of observed intakes, and thus, a UL or a safe level of intake could not be set. Based on available data and related uncertainties, the intake of added and free sugars should be as low as possible in the context of a nutritionally adequate diet. Decreasing the intake of added and free sugars would decrease the intake of total sugars to a similar extent. This opinion can assist EU Member States in setting national goals/recommendations.

Seaweeds and kelps, also known as macroalgae, have long been common in the East-Asian diet. During recent years, macroalgae have entered the global food market, and a variety of macroalgae products are now available for consumers. Some macroalgae species are known to be particularly rich in iodine, but little data regarding the iodine content of macroalgae-containing foods exists. The aim of this research study was to analyse the iodine content in a large variety of commercially available macroalgae-containing foods and supplements and to evaluate whether such products are sources of adequate dietary iodine. Ninety-six different products were collected after surveying the Norwegian market for commercially available macroalgae products, collected from three categories: 1) wholefood macroalgae products ( = 43), 2) macroalgae-containing foods ( = 39), and 3) dietary supplements containing macroalgae ( = 14). All products were analysed for iodine content by inductively coupled plasma-mass spectrometry (ICP-MS). The iodine content in one portion of wholefood macroalgae products ranged from 128 to 62,400 μg. In macroalgae-containing foods, the iodine content ranged from 30 to 25,300 μg per portion, and in supplements it ranged from 5 to 5,600 μg per daily dose. The species with the highest analysed iodine content were oarweed, sugarkelp and kombu, with mean iodine levels of 7,800, 4,469 and 2,276 μg/g, respectively. For 54 products, the intake of one portion or dose would exceed the tolerable upper intake level (UL) for iodine. The iodine content in the included products was variable and for most products high, exceeding the tolerable upper intake level (UL) if consumed as a serving or portion size. The labelling of macroalgae species included, and declaration of iodine content, were inadequate or inaccurate for several products. As macroalgae-containing products are unreliable iodine sources, inclusion of such products in the diet may pose a risk of consuming excessive amounts of iodine.

Amino acid supplementation may be indicated to correct for insufficient amino acid intake in healthy individuals, and in specific physiological or pathophysiological situations. However, there is a concern to not supplement beyond the tolerable upper intake level (UL) by determining parameters of no-observed-adverse-effect level (NOAEL) or lowest-observed-adverse-effect level (LOAEL) for each amino acid. Since the NOAEL and LOAEL values are at least one order of magnitude different when comparing the values obtained in rats and humans, the aim of this review is to evaluate to what extent the amino acid UL measured in the rat model, when referenced to the dietary usual consumption (UC) and dietary requirement (RQ) for indispensable amino acids, may be used as an approximation of the UL in humans. This review then compares the ratios of the NOAEL or LOAEL over UC and RQ in the rat model with the same ratios calculated in humans for the nine amino acids (arginine, serine, glycine, histidine, leucine, lysine, methionine, phenylalanine, and tryptophan) for which this comparison can be done. From the calculations made, it appears that for these 9 amino acids, the calculated ratios for rats and humans, although rather different for several amino acids, remains for all of them in the same order of magnitude. For tryptophan, tyrosine, and valine, the ratios calculated in rats are markedly different according to the sex of animals, raising the view that it may be also the case in humans.

PurposeThe upper tolerable intake level for vitamin D in the general population has been set at 4000 international units (IU) daily, but considerable uncertainty remains. We summarized reported harmful effects of a daily vitamin D supplement of 3200–4000 IU in trials lasting ≥ 6 months.MethodsWe performed a systematic review and meta-analysis of randomized controlled trials in several databases and identified 22 trials reporting safety data. Parameters of calcium metabolism, falls, hospitalization, and mortality were assessed.ResultsThe selected trials comprised a total number of 12,952 participants. All trials used supplemental vitamin D3. The relative risk (RR) of hypercalcemia in the vitamin D vs. control arm was 2.21 (95%CI: 1.26–3.87; 10 studies), with a vitamin D-induced frequency of hypercalcemia of 4 cases per 1000 individuals. Subgroup analysis in trials with > 100 and ≤ 100 study participants revealed an RR of 2.63 (95%CI: 1.30–5.30; 7 studies) and 0.80 (95%CI: 0.24–2.62; 3 studies), respectively (Pinteraction = 0.06). Risks of falls and hospitalization were also significantly increased in the vitamin D arm with an RR of 1.25 (95%CI: 1.01–1.55; 4 studies) and 1.16 (95%CI: 1.01–1.33; 7 studies), respectively. Risks of hypercalciuria, kidney stones, and mortality did not differ significantly between study arms. Quality assessment revealed high risk of incomplete reporting of safety-related outcome data.ConclusionSupplemental vitamin D doses of 3200–4000 IU/d appear to increase the risk of hypercalcemia and some other adverse events in a small proportion of individuals, indicating that this dose is not completely safe. In future studies, rigorous reporting of safety-related outcomes is needed when using moderately high doses of vitamin D.

Different European institutions have developed mathematical models to propose maximum safe levels either for fortified foods or for dietary supplements. The objective of the present study was to compare and check the safety of these different maximum safe levels (MSL) by using a probabilistic risk assessment approach. The potential maximum nutritional intakes were estimated by taking into account all sources of intakes (base diet, fortified foods and dietary supplements) and compared with the tolerable upper intake levels for vitamins and minerals. This approach simulated the consequences of both food fortification and supplementation in terms of food safety. Different scenarios were tested. They are the result of the combination of several MSL obtained using the previous models. The study was based on the second French Individual and National Study on Food Consumption performed in 2006–7, matched with the French food nutritional composition database. The analyses were based on a sample of 1918 adults aged 18–79 years. Some MSL in fortified foods and dietary supplements obtained independently were protective enough, although some others could lead to nutritional intakes above the tolerable upper intake levels. The simulation showed that it is crucial to consider the inter-individual variability of fortified food intakes when setting MSL for foods and supplements. The risk assessment approach developed here by integrating the MSL for fortified foods and dietary supplements is useful for ensuring consumer protection. It may be subsequently used to test any other MSL for vitamins and minerals proposed in the future.

Chlorogenic acid (CGA) is widely present in plant foods and has attracted much attention due to biological activities such as those which are antioxidant, anti-inflammatory, antibacterial, and antiviral. It plays a role in regulating glucose and lipid metabolism, improving insulin resistance, and reducing the risk of type 2 diabetes and cardiovascular diseases. The estimated dietary intake of CGA is 5 to 1000 mg/d. Based on the data from population intervention studies, daily oral doses of CGA at 13.5mg to 1200 mg can reduce fasting blood glucose (FBG), improve glucose tolerance, enable weight loss /prevent weight gain, and improve blood pressure in hypertensive patients. Daily intake of 200 mg or more may reduce FBG, with a dose-effect relationship in the range 13.5-500 mg/d. Therefore, a specific proposed level (SPL) of CGA to improve FBG could be >=200 mg/d. Data insufficiency does not allow formulation of a tolerable upper intake level (TUIL) for CGA.