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PubMed1997

Food intake and food choice: the role of the endogenous opioid peptides in the marsupial Sminthopsis crassicaudata.

Endogenous opioid peptides activate food seeking behaviour and influence macronutrient choice in a number of animal species and previous studies have suggested that the palatability of food is strongly modulated by the opioid feeding system. The effect of opioid peptides on appetite and food choice in marsupials has not been evaluated. The aim of these studies was to determine the effect of mu, delta and K opioid receptors on food intake and food choice in the marsupial Sminthopsis crassicaudata. When offered a choice of mealworms or laboratory diet after 24 h food deprivation, S. crassicaudata ate predominantly mealworms. After a 24 h fast, adult male S. crassicaudata were injected peripherally with opioid receptor antagonists or saline. Animals were re-fed with either their laboratory diet alone, or a choice of laboratory diet and mealworms. In animals re-fed with laboratory diet alone, naloxone at doses of 15 and 10 mg/kg produced a 31% (P < 0.05) and 38% (P < 0.05) respectively reduction in food intake in the first 30 min after laboratory diet was re-introduced, but lower doses had no effect. The selective delta antagonist naltrindole at 20 mg/kg resulted in a 65% (P < 0.01) reduction in food intake compared to controls between 30 and 60 min. The selective kappa opioid antagonist nor-binaltorphimine had no effect on the intake of laboratory diet. In animals offered a choice of laboratory diet and mealworms, naloxone doses of 1, 5, 10, 15 and 20 mg/kg significantly decreased intake in the first 0.5 h after re-feeding, due to a preferential suppression of the intake of mealworms. Naltrindole and nor-binaltorphimine had no effect on food choice. These studies demonstrate that endogenous opioid peptides influence both food intake and choice in S. crassicaudata and that the role of the opioid feeding system is in part modulated by food palatability. In S. crassicaudata these effects appear to occur predominantly by a mu opioid receptor mechanism.

Animals↗

PubMed1997

Relationship between food-specific IgE concentrations and the risk of positive food challenges in children and adolescents.

BACKGROUND: The double-blind, placebo-controlled food challenge (DBPCFC) is the "gold standard" for diagnosis of food hypersensitivity. Skin prick tests and RASTs are sensitive indicators of food-specific IgE antibodies but poor predictors of clinical reactivity. Previous studies suggested that high concentrations of food-specific IgE antibody were predictive of food-induced clinical symptoms. Because the CAP System FEIA (Pharmacia Diagnostics, Uppsala, Sweden) provides a quantitative assessment of allergen-specific IgE antibody, this study was undertaken to determine the potential utility of the CAP System FEIA in diagnosis of IgE-mediated food hypersensitivity. METHODS: Sera from 196 patients with food allergy were analyzed for specific IgE antibodies to egg, milk, peanut, soy, wheat, and fish by CAP System FEIA. Sera were randomly selected from 300 stored samples of children and adolescents who had been evaluated by history, skin prick tests, and DBPCFCs. The study population was highly atopic; all patients had atopic dermatitis, and approximately 50% had asthma and allergic rhinitis at the time of initial evaluation. The performance characteristics of the CAP System FEIA were compared with those of skin prick tests and the outcome of DBPCFCs or "convincing" histories of anaphylactic reactions. RESULTS: The prevalence of specific food allergies in the study population varied from 22% for wheat to 73% for egg. Allergy to egg, milk, peanut, and soy accounted for 87% of confirmed reactions. The performance characteristics of skin prick tests and CAP System FEIA (egg, milk, peanut, fish) were comparable, with excellent sensitivity and negative predictive accuracy but poor specificity and positive predictive accuracy. The performance characteristics of the CAP System FEIA for soy and wheat were poor. For egg, milk, peanut, and fish allergy, diagnostic levels of IgE, which could predict clinical reactivity in this population with greater than 95% certainty, were identified: egg, 6 kilounits of allergen-specific IgE per liter (kU[A]/L); milk, 32 kU(A)/L; peanut, 15 kU(A)/L; and fish, 20 kU(A)/L. CONCLUSIONS: When compared with the outcome of DBPCFCs, results of CAP System FEIA are generally comparable to those of skin prick tests in predicting symptomatic food hypersensitivity. Furthermore, by measuring the concentrations of food-specific IgE antibodies with the CAP System FEIA, it is possible to identify a subset of patients who are highly likely (>95%) to experience clinical reactions to egg, milk, peanut, or fish. This could eliminate the need to perform DBPCFCs in a significant number of patients suspected of having IgE-mediated food allergy.

Adolescent↗

PubMed2002

Characterization of household food insecurity in Québec: food and feelings.

This study was undertaken to understand food insecurity from the perspective of households who experienced it. The results of group interviews and personal interviews with 98 low-income households from urban and rural areas in and around Québec City, Canada, elicited the meaning of "enough food" for the households and the range of manifestations of food insecurity. Two classes of manifestations characterized the experience of food insecurity: (1) its core characteristics: a lack of food encompassing the shortage of food, the unsuitability of both food and diet and a preoccupation with continuity in access to enough food; and a lack of control of households over their food situation; and (2) a related set of potential reactions: socio-familial perturbations, hunger and physical impairment, and psychological suffering. The results substantiate the existence of food insecurity among Québecers and confirm that the nature of this experience is consistent with many of the core components identified in upstate New York. This study underlines the monotony of the diet, describes the feeling of alienation, differentiates between a lack of food and the reactions that it engenders, and emphasizes the dynamic nature of the experience.

Anxiety↗

PubMed2000

An evaluation of food photographs as a tool for quantifying food and nutrient intakes.

OBJECTIVE: To evaluate the errors incurred by young adults using single portion size colour food photographs to quantify foods and nutrients consumed at six meals on two non-consecutive days. DESIGN: Breakfast menus remained the same for the 2 days; but lunch and dinner menus varied. The amounts of food eaten by individuals were determined by weighing individual serving dishes pre- and post-consumption. The day after eating, all foods consumed were quantified in terms of fractions or multiples of the amounts shown in the food photographs. SUBJECTS: Thirty adult volunteers (15 male, 15 female), aged 18-36 years, completed the protocol for day one; 27 (90%) completed day two. RESULTS: Some foods were more difficult to quantify accurately than others. The largest error range was -38. 9% to +284.6% (cheese), whereas the smallest errors were incurred for juice (-21.5% to +34.6%, day one). All subjects who consumed muesli (day one) overestimated (+3.7% to +113.7%). No other foods were consistently over- or underestimated. For foods consumed at breakfast by the same subjects on both days, individual estimation errors were inconsistent in magnitude and/or direction. At the group level, most nutrients were estimated to within +/-10% of intake; exceptions were thiamin (+10.5%, day one) and vitamin E (-10.1%, day one; -15.3%, day two). Between 63% and 80% of subjects were correctly classified into tertiles on the basis of estimated intakes. CONCLUSIONS: Despite some large food quantification errors, single portion size food photographs were effective when used to estimate nutrient intakes at the group level. It remains to be established whether, under the conditions used in this study, more photographs per food would improve estimates of nutrient intake at the individual level.

Adolescent↗

PubMed2002

Reactivity to potential cross-reactive foods in fruit-allergic patients: implications for prescribing food avoidance.

BACKGROUND: Prescribing therapeutic elimination diets in patients with fruit allergy should include recommendations on which other foods of the same family or group may be safely consumed. Evidence-based data on the management of fruit allergy are lacking; therefore, advice may vary from just avoiding the offending fruit, to overly restrictive diets of the entire botanical family. The aims of this investigation were to assess clinical reactivity to potential cross-reactive foods in fruit-allergic patients, and the implications for prescribing specific therapeutic elimination diets. METHODS: Sixty-five adults diagnosed with clinical allergy to one or more fruits were evaluated for IgE-mediated allergy to other related foods, which might share cross-reactive antigens. Those with actual allergy to some Rosaceae fruit (including peach, apple, apricot, plum, and almond) underwent skin prick testing (SPT), food-specific IgE assessment by the Pharmacia CAP-FEIA system, and oral challenges with the entire group. For those with allergy to other fruits (chestnut, melon, banana, kiwi, or avocado) immunologic and clinical reactivity to all five were evaluated. Since a number of people in the study also had proven clinically allergy to some nut or legume (peanut, sunflower seed, walnut, pistachio, or hazelnut), the reactivity to the entire set was investigated. RESULTS: Thirty-four of those tested (52%) were found to be clinically allergic to more than one fruit, so 125 allergic reactions occurred in the 65 patients. Peach, melon, kiwi, apple, and banana accounted for 72% of allergic reactions. Forty-two (65%) had sensitization to pollens, causing seasonal allergic rhinitis and/or asthma, and 18 (28%) were sensitized to latex. The 65 with IgE-mediated fruit allergy underwent 351 additional SPT and food-specific IgE determinations with potential cross-reactive foods considered in this study; 223 (64%) of these results were positive. The routine challenges with potential cross-reactive foods uncovered 18 further reactions in 14 (22%) out of 65 (to avocado in seven; apricot in three; plum in one; almond and peanut in one; banana and hazelnut in one; avocado, banana and kiwi in one). Only 8% (18/223) of positive results for SPT, or food-specific IgE levels of greater than 0.35 kU(A)/l to potential cross-reactive foods investigated in this study, were clinically relevant. CONCLUSION: Elimination diets that rely on total group avoidance, or only on the results of allergy testing, might have resulted in unnecessary restriction of 205 foods in the 65 people studied. The lack of routine oral challenges with related fruits--before prescribing dietary restriction--may have allowed 18 food reactions in one-fifth (14/65) of patients to be overlooked.

Adolescent↗

PubMed2000

The influence of survey duration on estimates of food intakes and its relevance for public health nutrition and food safety issues.

OBJECTIVE: To examine the influence of food consumption survey duration on estimates of percentage consumers, mean total population intakes and intakes among consumers only and to consider its relevance for public health nutrition and food safety issues. DESIGN: Prospective food consumption survey. SETTING: A multicentre study in five centres in the European Union-Dublin, Ghent, Helsinki, Potsdam and Rome. SUBJECTS: Teenage subjects were recruited through schools; 948 (80%) out of 1180 subjects completed the survey. INTERVENTIONS: 14-day food diaries were used to collect the food consumption data. RESULTS: For mean total population intakes, 53% of the foods had slopes significantly different to 0 (P<0.05). In practical terms (g/day), these differences were small, with 41% of foods having differences of </=1 g/day and a further 35% having differences of 1-5 g/day. Estimates of percentage consumers based on 3 days and 14 days were 1.9 and 3.6 times the 1-day estimate, respectively. For 72% of foods, at least 50% of non-consumers on day 1 became consumers over the subsequent 13 days. Estimates of mean consumer only intakes based on 3 days and 14 days were 53% and 32% of the 1 day value. CONCLUSION: In practical terms, survey duration influences estimates of percentage consumers and intakes among consumers only but not mean total population intakes. Awareness of this influence is important for improved interpretation of dietary data for epidemiological studies, development of food-based dietary guidelines and food chemical intakes. SPONSORSHIP: The Institute of European Food Studies, a non-profit research organization based in Trinity College Dublin. European Journal of Clinical Nutrition (2000) 54, 166-173

Adolescent↗

PubMed1985

Family food purchases and home food consumption: comparison of nutrient contents.

Estimates of nutrient intakes based on food purchasing records modelled on the National Food Survey (NFS) were compared with nutrient intakes calculated from food consumption records based on a semi-weighted method, a combination of weighing and household measurement techniques. Of eighty-two families in Cambridge who completed the study, thirty-two were volunteers and fifty were from a random sample in which the co-operation rate was 73%. The estimated energy and nutrient contents of the Cambridge food purchases were very similar to those reported by the NFS for families of similar composition and income. The energy intakes obtained by the semi-weighed method were compared with results from twenty-five studies of energy intake based on quantitative measurements of food consumption: there was no evidence to suggest that the semi-weighed method consistently under- or overestimated intakes in the Cambridge subjects. Purchases adjusted to allow for waste and consumption of food by visitors contained significantly more energy, protein, carbohydrate, calcium, iron and dietary fibre than measured home food consumption. There was no significant difference in the nutrient content of purchases and consumption per 4.184 MJ (1000 kcal), with the exception of Fe and ascorbic acid. Measured wastage of edible food in thirty-one families averaged 3.2% of purchases. Estimate of wastage in all eighty-two families was 3.8%, and consumption of food by visitors accounted for 3.0% of purchases. The excess of purchases over measured home food energy intake is probably accounted for by a net increase in larder stocks rather than wastage, consumption of food by visitors, or under-recording of intakes.

Adolescent↗

PubMed2004

Selection of food items for inclusion in a newly developed food-frequency questionnaire.

OBJECTIVES: To highlight the differences between the food list required in a food-frequency questionnaire (FFQ) to rank people by their intake and the food items that contribute to absolute intake, and to discuss possible applications. METHODS: We conducted a nutritional survey among 1173 adults using an adapted 24-hour recall questionnaire. STATISTICAL ANALYSIS: To develop an FFQ, we analysed the 24-hour recall survey data by performing a stepwise multiple regression after grouping conceptually similar food items into 175 food groups. RESULTS: In total, 126 food groups were included in the developed FFQ in order to explain at least 80% of the variance in the consumption of each of 27 nutrients. The nutrients that were explained by a few food groups were vitamin A (one food group), alcohol (two), beta-carotene (two), vitamin E (three) and cholesterol (five). Nutrients that were explained by a large number of food groups were energy (37 food groups), potassium (31), magnesium (31), dietary fibre (30), phosphorus (31) and sodium (29). Using energy intake as an example, soft drinks were the best between-person energy classifiers, while providing only 2.4% of the total energy intake. Wine, seeds and nuts, which contributed highly to the variance, were minor energy contributors. In contrast, milk, sugar, fried chicken/turkey breast or whole chicken/turkey, which explained little of the variation in the population, were major energy contributors. CONCLUSIONS: Developing an FFQ on the basis of common foods may not explain the between-person variation required for ranking individual intake in diet-disease studies. Producing lists of "discriminating items" can be a useful application in developing mini-FFQs for selected nutrients.

Adult↗

PubMed1999

An analysis of the incremental value of retaining brand-level information in food consumption databases in estimating food additive intake.

In the Dietary and Nutritional Survey of British Adults (DNSBA) food consumption database, brand level intake data are recorded for 2197 subjects over 7 days. This study set out to examine the incremental value of such brand level data in food consumption studies to estimate additive intake. The food codes in the DNSBA database were re-arranged into 14 food categories within each of which were varying numbers of both sub-categories of foods and of brands. Intake of the 97.5th percentile for brands and sub-categories were compared with intakes at the 97.5th percentile of the appropriate food category. Taking > or = 60 consumers as the minimal sample size for which a 97.5th percentile statistic can be calculated, only 6% of the 1363 brands listed had sufficient data to work with. Of the 14 food categories, six had a sub-category with a 97.5th percentile in excess of that of the category but none exceeded 1.3 x 97.5th percentile intake of the category. Of the 85 brands for which there were > or = 60 consumers, only 11 had 97.5th percentile intakes in excess of that statistic for the relevant food category and none exceeded a multiple of 1.3 times the category 97.5th percentile intakes. Unless dietary surveys are very large and carried out for longer periods of time, there is little value in retaining food consumption data at brand level. If 1.3x the intake of an additive from a given food category at the 97.5th percentile does not exceed the ADI, no sub-category or brand appears to do so. This may provide a valuable technique in crude estimates of food additive intake.

Adolescent↗

PubMed1999

Adverse reactions to food and food allergy in young children in Iceland and Sweden.

OBJECTIVE: To investigate the prevalence of adverse reactions to food and food allergy in Icelandic and Swedish 18-month-old children. DESIGN: Prospective multicentre comparative study. SETTING: Primary health care centres in Sweden and Iceland. SUBJECTS: A total of 324 children in Iceland and 328 in Sweden who attended for regular 18-month check-up. MAIN OUTCOME MEASURES: Adverse reaction to food according to questionnaire, and food allergy according to skin prick tests and double blind food challenge tests. RESULTS: Adverse reactions to food were reported in 27% of children in Iceland and 28% in Sweden. Food allergy was confirmed in 2.0% in both countries. Allergy among other family members was reported in 45% of the Icelandic children and 62% in the Swedish (p < 0.001). Indoor smoking was reported by 30% of the Icelandic families and 3% of the Swedish. Respiratory infections were reported significantly more often in Icelandic children than Swedish. CONCLUSION: Adverse reactions to food and food allergy were similar in Icelandic and Swedish children. At the age of 18 months one can expect to confirm food allergy in approximately one out of 15 children with reported adverse reactions to food.

Food Hypersensitivity↗

PubMed1991

Development of a semiquantitative food frequency questionnaire to assess food, energy and nutrient intake in Denmark.

Foods to be included in a Danish self-administered semiquantitative food frequency questionnaire were identified from food tables developed, together with data collected, for the survey 'Dietary habits in Denmark, 1985'. The questionnaire was to be used in a prospective study on diet, cancer and health, and the aim was to rank individuals with regard to intake of 19 different nutrients considered of prime importance in human carcinogenesis. The questionnaire for the dietary survey included 247 foods and recipes. From stepwise multiple regression analyses with the intake of each of the 19 nutrients as the dependent variable and the intake of the 247 foods and recipes as independent variables, the foods in the models explaining 90% of the between-person variability were considered for the final questionnaire. All relevant analyses were performed for the study group as a whole, for men and women separately, and in each gender for subgroups of energy intake. Taken together, the models explaining 90% of the between-person variability identified a total of 74 foods or recipes, which were important predictors of the intake of one or more of the nutrients considered. A few foods were excluded and a few foods were added to the final questionnaire based on common biological background information, and on information on foods providing important amounts of given nutrients, but which failed to contribute to regression analyses. The 92 foods and recipes, which were included in the final questionnaire provided altogether 81% of the average total supply of the nutrients.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed2001

Household food insecurity with hunger is associated with women's food intakes, health and household circumstances.

This study investigated food intake patterns and contextual factors related to household food insecurity with hunger among a sample of 153 women in families seeking charitable food assistance in Toronto. Women in households characterized by food insecurity with severe or moderate hunger over the past 30 d (as assessed by the Food Security Module) reported lower intakes of vegetables and fruit, and meat and alternatives than those in households with no hunger evident. Women were more likely to report household food insecurity with hunger over the past 12 mo and 30 d if they also reported longstanding health problems or activity limitations, or if they were socially isolated. The circumstances that women identified as precipitating acute food shortages in their households included chronically inadequate incomes; the need to meet additional, unusual expenditures; and the need to pay for other services or accumulated debts. Women who reported delaying payments of bills, giving up services, selling or pawning possessions, or sending children elsewhere for a meal when threatened with acute food shortages were more likely to report household food insecurity with hunger. These findings suggest that expenditures on other goods and services were sometimes foregone to free up money for food, but the reverse was also true. Household food insecurity appears inextricably linked to financial insecurity.

Adult↗

PubMed2002

Foods provided through U.S. Government Emergency Food Aid Programs: policies and customs governing their formulation, selection and distribution.

This report describes the food commodities that are used in U.S. emergency food aid programs and outlines issues in their distribution, selection and formulation that may limit their ability to meet the nutrition needs of recipients. Issues are being raised at this time because the U.S. Congress plans to renew the authorizing legislation by the end of 2002. The author summarizes quantity and quality problems with food aid contributions and the difficulties experienced with the coordination of food aid with related needs of disaster victims. He identifies the foods supplied for emergency feeding by the U.S. Government and the World Food Program, and describes the limited applications of nutrition science to the formulation of the processed foods provided through U.S. food programs. The core of the report outlines the dominant nonnutritional priorities, stemming from the linkages to U.S. agricultural supply markets, U.S. commercial food interests, food aid pledging customs and difficulties in U.S. Government humanitarian response coordination. The presentation concludes with a review of issues, emphasizing the need for further studies, and some suggestions for shaping future food aid programs and policy with a strengthened capacity for protecting and promoting the nutritional status of disaster victims.

Financing, Government↗

PubMed1996

Chronic food restriction and acute food deprivation decrease mRNA levels of opioid peptides in arcuate nucleus.

Although opioid administration induces food intake, the relationship between endogenous opioid synthesis and food consumption is unclear. Two studies examined the effects of food restriction and deprivation on opioid mRNA levels in the arcuate nucleus (ARC) of the rat. Body weight significantly decreased following food restriction and deprivation (P < 0.0001). In experiment 1, food restriction of 10,20,30, and 40% (g) of ad libitum intake for 14 days decreased proDynorphin (proDyn), proEnkephalin (proEnk), and proOpiomelanocortin (POMC) mRNA levels in a linear fashion relative to changes in body weight (r = 0.398, P = 0.0011; r = 0.455, P = 0.0028; r = 0.292, P = 0.0642, respectively). In experiment 2, 48 h deprivation significantly decreased mRNA levels of proDyn and POMC by 23.7% (P < 0.05) and 45.6% (P < 0.01), respectively, whereas 24 h food deprivation decreased POMC mRNA by 43.% (P < 0.01). proEnk mRNA was not affected by 24- or 48-h food deprivation. Restricting food intake suppressed mRNA levels of proDyn, proEnk, and POMC by 29.7, 22.3, and 44.4%, respectively, in 20% restricted rats and by 35.5, 26.8, and 45.6%, respectively, in 40%restricted rats (P < 0.01). It appears that ARC mRNA levels of proDyn, proEnk, and POMC are directly related to the amount of food consumed and/or changes in body weight in food-restricted and food-deprived rats.

Animals↗

PubMed1993

Relationship of mothers' food choice criteria to food intake of preschool children: identification of family subgroups.

This study investigated the relationship between potential criteria mothers use to select foods for their children, their food knowledge, and food consumption of their children. Participants were 218 predominantly Latino mothers and their 4 to 5-year-old children. Mothers rated 17 foods in terms of 10 food attributes (how tasty specific foods were to their child, whether they were convenient to prepare, etc.). Within-person correlation coefficients were then calculated between these ratings and reported frequency of consumption of these same 17 foods. These correlations were then used in a k-means cluster analysis to identify six distinct subgroups of families, who had different orientations ranging from "high health" to "high taste." Children in the "high health" groups had diets significantly lower in calories, fat, saturated fat, and sucrose and higher in fiber and vitamin A from 24-hour dietary recalls reported by mothers. Mothers' health knowledge was also correlated with nutrient takes of children. These data indicate that families can be segmented according to the importance of beliefs about healthfulness of foods and that this segmentation predicts quality of diet of children. This study suggests that interventions should be designed to increase mothers beliefs in the importance of health in choosing foods. For those mothers whose food choices are dominated by children's tastes, interventions should be directed at how to prepare healthful foods to taste good to children.

Adult↗

PubMed2002

Do street food vendors sell a sufficient variety of foods for a healthful diet? The case of Nairobi.

This study examined whether street food vendors sell a sufficient variety of foods for a healthful diet. It was hypothesized that vendors sold only low-cost food groups to enable the buyer to afford the food while the vendor also made a profit. A structured questionnaire was administered to 580 vendors in three selected locations. Data included product names, ingredients, methods of preparation, and the sex of the vendor. A little more than half of the vendors (53%) sold food of only one group; 44% sold cereals. Overall, 36% of vendors, mostly men, sold only carbohydrate products. The percentage of vendors selling foods of more than one group was higher in the working area (53%) than in the slum area (43%, p < .05), and it was higher in both of these areas taken together than in the lower-middle income area (21%, p < .001). Micronutrient and mixed-nutrient products were associated with female vendors. Although a slight majority of all street vendors sell foods of only one group, women vendors are capable of supplying a sufficient variety of food groups that consumers can afford. It appears that consumer purchasing power dictates the food groups provided by vendors, especially cereal-based-foods. A policy on micronutrient fortification of cereal flours and fats used in popular street food preparation needs to be considered. This could be coupled with consumer and vendor education programs focusing on the importance of healthful diets.

Africa South of the Sahara↗

PubMed1998

[Role of food interaction pharmacokinetic studies in drug development. Food interaction studies of theophylline and nifedipine retard and buspirone tablets].

Due to several mechanism, meals may modify the pharmacokinetics of drug products, thereby eliciting to clinically significant food interaction. Food interactions with the drug substance and with the drug formulation should be distinguished. Food interaction of different drug products containing the same active ingredient can be various depending on the pharmaceutical formulation technology. Particularly, in the case of modified release products, the food/formulation interaction can play an important role in the development of food interaction. Well known example, that bioavailability of theophylline can be influenced in different way (either increased, decreased or unchanged) by concomitant intake of food in the case of different sustained release products. The role and methods of food interaction studies in the different kinds of drug development (new chemical entity, modified release products, generics) are reviewed. Prediction of food effect response on the basis of the physicochemical and pharmacokinetic characteristics of the drug molecule or formulations is discussed. The results of three food interaction studies carried out the products of EGIS Pharmaceuticals Ltd. are also reviewed. The pharmacokinetic parameters of theophyllin 400 mg retard tablet were practically the same in both fasting condition and administration after consumption of a high fat containing standard breakfast. The ingestion of a high fat containing breakfast, increased the AUC of nifedipine from 259.0 +/- 101.2 ng h/ml to 326.7 +/- 122.5 ng h/ml and Cmax from 34.5 +/- 15.9 ng/ml to 74.3 +/- 23.9 ng/ml in case of nifedipine 20 mg retard tablet, in agreement with the data of literature. The statistical evaluation indicated significant differences between the pharmacokinetic parameters in the case of two administrations (before and after meal). The effect of a high fat containing breakfast for a generic version of buspiron 10 mg tablet and the bioequivalence after food consumption were studied in a single-dose, three-way (test and reference products administered after consumption of standard breakfast, as well as test product in fasting condition), cross-over, food effect bioequivalence study. According to the results, the test product--which, in a former study proved to be bioequivalent with the reference product in fasting state--is bioequivalent with the reference product under feeding conditions and the food intake influenced the pharmacokinetics of the test tablets.

Buspirone↗

PubMed1996

The safety assessment of novel foods. Guidelines prepared by ILSI Europe Novel Food Task Force.

The diversity of novel foods and novel ingredients covered by the scope of the EU regulation is such that a check list approach to safety evaluation is inappropriate. Rather, a case-by-case approach is required taking into account the composition of the novel food, its intake, its role in the diet and the intended target group. The SAFEST approach provides a means of targeting the safety evaluation on those aspects, nutritional or toxicological, of a novel food which are of particular concern. Using this approach, novel foods are assigned to one of three classes on the basis of certain background information. For those novel foods which can be shown to be in SAFEST class 1, namely those which are substantially equivalent to a traditional counterpart, no further information is required to demonstrate their safety. For those novel foods in SAFEST class 2, i.e. those sufficiently similar to a traditional counterpart or differing from it only in particular, well defined, characteristics, the evaluation will focus on those differences. Only in the case of novel foods which are not in class 1 or class 2 is extensive testing of the whole food likely to be required. Even in these cases, the testing should follow a scientifically-based hierarchical approach involving: literature reviews; chemical analysis; appropriate in vitro and in vivo tests; and, if necessary, confirmation of safety and nutritional value in humans. Examination of the causes of any adverse effects reported by consumers after the novel food or ingredient has been approved and is introduced into the market may provide additional reassurance of safety.

Animals↗