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OBJECTIVE We carried out a secondary analysis in high-risk patients with a previous myocardial infarction (MI) and diabetes in the Alpha Omega Trial. We tested the hypothesis that in these patients an increased intake of the n-3 fatty acids eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and α-linolenic acid (ALA) will reduce the incidence of ventricular arrhythmias and fatal MI. RESEARCH DESIGN AND METHODS A subgroup of 1,014 post-MI patients with diabetes aged 60–80 years was randomly allocated to receive one of four trial margarines, three with an additional amount of n-3 fatty acids and one placebo for 40 months. The end points were ventricular arrhythmia–related events and fatal MI. The data were analyzed according to the intention-to-treat principle, using multivariable Cox proportional hazards models. RESULTS The patients consumed on average 18.6 g of margarine per day, which resulted in an additional intake of 223 mg EPA plus 149 mg DHA and/or 1.9 g ALA in the active treatment groups. During follow-up, 29 patients developed a ventricular arrhythmia–related events and 27 had a fatal MI. Compared with placebo patients, the EPA-DHA plus ALA group experienced less ventricular arrhythmia–related events (hazard ratio 0.16; 95% CI 0.04–0.69). These n-3 fatty acids also reduced the combined end-point ventricular arrhythmia–related events and fatal MI (0.28; 0.11–0.71). CONCLUSIONS Our results suggest that low-dose supplementation of n-3 fatty acids exerts a protective effect against ventricular arrhythmia–related events in post-MI patients with diabetes.

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

Background - Results from prospective cohort studies and randomized, controlled trials have provided evidence of a protective effect of n-3 fatty acids against cardiovascular diseases. We examined the effect of the marine n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and of the plant-derived alpha-linolenic acid (ALA) on the rate of cardiovascular events among patients who have had a myocardial infarction. Methods - In a multicenter, double-blind, placebo-controlled trial, we randomly assigned 4837 patients, 60 through 80 years of age (78% men), who had had a myocardial infarction and were receiving state-of-the-art antihypertensive, antithrombotic, and lipidmodifying therapy to receive for 40 months one of four trial margarines: a margarine supplemented with a combination of EPA and DHA (with a targeted additional daily intake of 400 mg of EPA–DHA), a margarine supplemented with ALA (with a targeted additional daily intake of 2 g of ALA), a margarine supplemented with EPA–DHA and ALA, or a placebo margarine. The primary end point was the rate of major cardiovascular events, which comprised fatal and nonfatal cardiovascular events and cardiac interventions. Data were analyzed according to the intention-totreat principle, with the use of Cox proportional-hazards models. Results - The patients consumed, on average, 18.8 g of margarine per day, which resulted in additional intakes of 226 mg of EPA combined with 150 mg of DHA, 1.9 g of ALA, or both, in the active-treatment groups. During the follow-up period, a major cardiovascular event occurred in 671 patients (13.9%). Neither EPA–DHA nor ALA reduced this primary end point (hazard ratio with EPA–DHA, 1.01; 95% confidence interval [CI], 0.87 to 1.17; P = 0.93; hazard ratio with ALA, 0.91; 95% CI, 0.78 to 1.05; P = 0.20). In the prespecified subgroup of women, ALA, as compared with placebo and EPA–DHA alone, was associated with a reduction in the rate of major cardiovascular events that approached significance (hazard ratio, 0.73; 95% CI, 0.51 to 1.03; P = 0.07). The rate of adverse events did not differ significantly among the study groups. Conclusions - Low-dose supplementation with EPA–DHA or ALA did not significantly reduce the rate of major cardiovascular events among patients who had had a myocardial infarction and who were receiving state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy. (Funded by the Netherlands Heart Foundation and others; ClinicalTrials.gov number, NCT00127452.)

"Functional" foods are branded foods, which claim, explicitly or implicitly, to improve health or well being. We review typical functional foods and their ingredients, efficacy, and safety. We also review regulations for health claims for foods worldwide. These regulations often allow manufacturers to imply that a food promotes health without providing proper scientific evidence. At the same time, regulations may ban claims that a food prevents disease, even when it does. We offer a plea for regulations that will permit all health claims that are supported by the totality of scientific evidence, and ban all claims that suggest an unproven benefit.

The increasing number of elderly people above 65 years of age is extremely heterogenous with regard to sickness and health. As a result, the nutritional needs and food consumption also vary. "Anorexia of aging", leading to nutritional deficiencies, is a common syndrome in the elderly people and may be either caused by or result in loss of functions and accelerated aging. Early detection of malnutrition and intervention with supplements or an adequate diet should stop the negative health spiral. A limited number of intervention trials, including Dutch ones, have demonstrated a positive effect on the nutritional and immune status. However, the improvement in physical and mental functions as a result of supplementation is less clear. The results of larger current trials on the effect of supplementation with, for excample, vitamin D, folic acid, vitamin B12 and complete enriched products will provide more clarity in the future on the necessity of supplementation for elderly peopleThe increasing number of elderly people above 65 years of age is extremely heterogeneous with regard to sickness and health. As a result, the nutritional needs and food consumption also vary. 'Anorexia of aging', leading to nutritional deficiencies, is a common syndrome in the elderly people and may be either caused by or result in loss of functions and accelerated aging. Early detection of malnutrition and intervention with supplements or an adequate diet should stop the negative health spiral. A limited number of intervention trials, including Dutch ones, have demonstrated a positive effect on the nutritional and immune status. However, the improvement in physical and mental functions as a result of supplementation is less clear. The results of larger current trials on the effect of supplementation with, for example, vitamin D, folic acid, vitamin B-12 and complete enriched products will provide more clarity in the future on the necessity of supplementation for elderly people.

Herbal food supplements claiming to reduce weight may contain active pharmacological ingredients (APIs) that can be used for the treatment of overweight and obesity. The aim of this study was to determine whether herbal food supplements for weight loss on the Dutch market contain APIs with weight loss properties. Herbal food supplements intended for weight loss (n = 50) were sampled from August 2004 to May 2013. An HPLC-DAD-MS/MS method was used to screen for the presence of the APIs in herbal supplements. In 24 samples the APIs sibutramine, desmethylsibutramine (DMS), didesmethylsibutramine (DDMS), rimonabant, sildenafil and/or the laxative phenolphthalein were identified 41 times. The presence of these APIs was, however, not stated on the label. The potential pharmacological effects of the detected APIs were estimated using data from reported effective doses of approved drugs. Use of 20 of the 24 herbal food supplements may result in potential pharmacological effects. Furthermore, risk assessment of phenolphthalein, a suspected carcinogen and found to be present in 10 supplements, based on the margin of exposure (MOE) approach, resulted in MOE values of 96–30 000. MOE values lower than 10 000 (96–220) were calculated for the daily intake levels of four out of these 10 supplements in which phenolphthalein was found. However, taking into account that weight loss preparations may be used for only a few weeks or months rather than during a lifetime, MOE values may be two to three orders of magnitude higher. The current study shows that the use of food supplements with sibutramine, DMS, DDMS and/or phenolphthalein could result in pharmacological effects.

The popularity of herbal products, especially plant food supplements (PFS) and herbal medicine is on the rise in Europe and other parts of the world, with increased use in the general population as well as among specific subgroups encompassing children, women or those suffering from diseases such as cancer. The aim of this paper is to examine the PFS market structures in European Community (EC) Member States as well as to examine issues addressing methodologies and consumption data relating to PFS use in Europe. A revision of recent reports on market data, trends and main distribution channels, in addition an example of the consumption of PFS in Spain, is presented. An overview of the methods and administration techniques used to assess individual food consumption as a starting point, including their uses and limitations, as well as some examples of studies that collect Food Supplement (FS) information, including herbal/botanical/plant-derived products are also discussed. Additionally, the intake estimation process of food nutrients is described and used to propose the PFS ingredients intake estimation process. Nationally representative PFS consumption data is scarce in Europe. The majority of studies have been conducted in Scandinavia and the UK. However the heterogeneity of definitions, study design and objectives make it difficult to compare results and extrapolate conclusions.

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

Background & aims: The elderly are at an increased risk of poor nutritional status which is mutually interacting with functional status. We evaluated the effects of a liquid nutrition supplement on anthropometric and functional indices in elderly people. Methods: Subjects (n=68; mean age=82 +/- 7 years) with body mass index less than or equal to 25 kg/m(2) received either a supplement or a placebo for 6 months. Anthropometric (body weight, bicielectrical impedance, calf circumference), biochemical (albumin, prealbumin), functional parameters (handgrip strength, timed 'up and go' test) and dietary intake were measured. Activities of daily living and Nottingham Health Profile (NHP) were assessed. Results: No compensation of energy intake occurred. After 6 months, the supplement group had gained more weight (+1.6 kg) than the placebo group (+0.3 kg) (P=0.03). No other significant changes in anthropometric, functional or blood parameters were seen. There was a significant improvement on the section 'sleep' of the NHP (mean change +/- SE=-0.38 +/- 0.19 for supplement vs 0.24 +/- 0.19 for placebo, P=0.03). Conclusion: Dietary supplementation led to an increase in body weight and had a positive influence on sleep in elderly persons. Supplementation did not affect energy intake from regular meals and thus resulted in additional energy intake. (C) 2003 Elsevier Science Ltd. All rights reserved.

The increasing number of elderly people above 65 years of age is extremely heterogenous with regard to sickness and health. As a result, the nutritional needs and food consumption also vary. "Anorexia of aging", leading to nutritional deficiencies, is a common syndrome in the elderly people and may be either caused by or result in loss of functions and accelerated aging. Early detection of malnutrition and intervention with supplements or an adequate diet should stop the negative health spiral. A limited number of intervention trials, including Dutch ones, have demonstrated a positive effect on the nutritional and immune status. However, the improvement in physical and mental functions as a result of supplementation is less clear. The results of larger current trials on the effect of supplementation with, for excample, vitamin D, folic acid, vitamin B12 and complete enriched products will provide more clarity in the future on the necessity of supplementation for elderly peopleThe increasing number of elderly people above 65 years of age is extremely heterogeneous with regard to sickness and health. As a result, the nutritional needs and food consumption also vary. 'Anorexia of aging', leading to nutritional deficiencies, is a common syndrome in the elderly people and may be either caused by or result in loss of functions and accelerated aging. Early detection of malnutrition and intervention with supplements or an adequate diet should stop the negative health spiral. A limited number of intervention trials, including Dutch ones, have demonstrated a positive effect on the nutritional and immune status. However, the improvement in physical and mental functions as a result of supplementation is less clear. The results of larger current trials on the effect of supplementation with, for example, vitamin D, folic acid, vitamin B-12 and complete enriched products will provide more clarity in the future on the necessity of supplementation for elderly people. Het toenemend aantal ouderen boven de 65 jaar is in termen van gezondheid en ziekte zeer heterogeen. Hierdoor variëren ook de voedingsbehoeften en voedselconsumptie. Ouderdomsanorexia, leidend tot voedingstekorten, komt bij ouderen veel voor, met als oorzaak of gevolg functieverlies en een versneld verouderingsproces. Het tijdig signaleren en interveniëren met supplementen of een adequate goed verzorgde voeding, zou deze negatieve gezondheidsspiraal moeten tegengaan. Beperkte interventiestudies op dit gebied, waaronder Nederlandse, geven een positief effect aan op de voedingstoestand en immuunstatus. Verbetering van lichamelijke en geestelijke functies door suppletie is minder duidelijk. Resultaten van lopende grotere interventiestudies met onder meer vitamine D, foliumzuur en vitamine B12, maar ook met complete verrijkte producten, zullen in de toekomst meer duidelijkheid geven over de noodzaak van voedingsaanvulling bij oudere personen