Search

OBJECTIVES: Data on the iodine content of foods are needed to assess intake and plan dietary guidance. Iodine is central for thyroid function in human growth, reproduction, neurologic development and energy metabolism, and inadequate or excessive intakes can cause thyroid dysfunction and/or disease. Overall, U.S. iodine intake is sufficient, but some women of reproductive age and pregnant women may be at risk for deficiency, as well as people whose dietary patterns do not include iodine-rich foods. METHODS: A Special Interest Database (SID) was developed through the collaboration of the Methods and Application of Food Composition Laboratory (USDA), the Food and Drug Administration (FDA), and the Office of Dietary Supplements (NIH). Data for foods and beverages were derived from samples analyzed by USDA and the FDA Total Diet Study; foods included seaweed, fish and other seafood, dairy, iodized salt, eggs, and commercial foods; metadata were captured as varying iodine levels may arise from feed supplementation, iodophor use, and iodine-containing ingredients in processed foods. Samples were analyzed for iodine using inductively coupled plasma mass spectrometry (ICP-MS). Quality control included certified reference materials and secondary in-house controls. RESULTS: The Special Interest Database on Iodine (https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/methods-and-application-of-food-composition-laboratory/mafcl-site-pages/iodine/) was released in 2020 and includes food descriptions, means, standard deviations, value ranges, sample sizes, and supporting information for 430 foods. Foods continue to be analyzed for iodine and added to the database. In addition, iodine intakes of the U.S. population are being calculated by mapping the iodine content of foods to food consumption data from the 2014 U.S. National Health and Nutrition Examination Survey (NHANES) and eventually more recent NHANES dietary data. CONCLUSIONS: The SID on Iodine and the mapped NHANES data provide needed information to monitor iodine status and develop dietary guidance for the general U.S. population and vulnerable subgroups. Furthermore, the database can provide a valuable tool for other research programs and clinical applications in iodine nutrition. FUNDING SOURCES: NIH Office of Dietary Supplements.

Data on the iodine content of foods and dietary supplements are needed to develop general population intake estimates and identify major contributors to intake. Samples of seafood, dairy products, eggs, baked products, salts, tap water, other foods and beverages, and dietary supplements were collected according to established sampling plans of the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Samples were assayed for iodine content using inductively coupled plasma mass spectrometry with rigorous quality control measures. The food data were released through a collaboration of USDA, FDA, and the Office of Dietary Supplements-National Institutes of Health (ODS-NIH) as the USDA, FDA, and ODS-NIH Database for the Iodine Content of Common Foods at www.ars.usda.gov/mafcl. Iodine data for dietary supplements are available in the ODS-USDA Dietary Supplement Ingredient Database and the ODS Dietary Supplement Label Database. Data from the iodine databases linked to national dietary survey data can provide needed information to monitor iodine status and develop dietary guidance for the general U.S. population and vulnerable subgroups. This iodine information is critical for dietary guidance development, especially for those at risk for iodine deficiency (i.e., women of reproductive age and young children). National Institutes of Health's Office of Dietary Supplements Published version This work was funded by the National Institutes of Health's Office of Dietary Supplements and in-kind contributions from the USDA and FDA. Public domain – authored by a U.S. government employee

Background: Iodine is an essential nutrient required for normal thyroid function in all age groups as well as healthy fetal, infant, and child development and growth. Because iodine levels in most foods are low, iodine usually must be provided through dietary supplements or fortified foods (such as salt). In recent NHANES cycles, sub-optimal iodine status has been observed in some U.S. populations, most notably pregnant women. Recent health campaigns have emphasized consuming less sodium and have focused on the primary source of the excess sodium in the U.S. diet: commercially prepared foods, most of which are made with non-iodized salt. Also, recent secular trends towards less home cooking and more use of non-iodized table salts may be contributing to relatively low usage of iodized salt, which was estimated in 2014 to comprise only half of retail salt sales. Therefore, for individuals who also limit their home use of salt in food preparation or at the table, an unintended consequence may be a decline in iodine intake. Population-level data thus are needed on the relative contributions of various foods to iodine intake in relation to iodine status markers, to characterize population groups at risk and develop guidance on appropriate dietary and supplementation strategies. Objective: Describe new measures of iodine intake and iodine status added into NHANES 2019-20, which is a nationally representative survey of the U.S. population. Methods: Iodine intake is being assessed through a questionnaire about household salt types (such as iodized salt or sea salt) and measured iodine content of household iodized salt, as well as individual 24-hour dietary recalls and use of iodine containing dietary supplements. This will be the first time NHANES will estimate dietary iodine intake using a newly developed USDA Special Interest Database on Iodine Content of Foods. Biomarkers include a thyroid panel (including thyroglobulin), inhibitors of iodine uptake in the thyroid (e.g., perchlorates), and urinary iodine concentration. Conclusions: The upcoming NHANES cycle will yield novel data on U.S. population coverage of household iodized salt, as well as individual thyroid and iodine status in relation to dietary iodine intake. Groups at risk from increased physiologic need or dietary preferences that limit iodine sources will be identified. A key tool in undertaking this work will be a new food composition database on the iodine content of U.S. foods. Clarification of key sources of iodine in the U.S. diet will be important in developing dietary guidance.

Objective To describe the history, key features, recent enhancements, and common applications of the Dietary Supplement Label Database (DSLD). Background and history Although many Americans use dietary supplements, databases of dietary supplements sold in the United States have not been widely available. The DSLD, an easily accessible public-use database was created in 2008 to provide information on dietary supplement composition for use by researchers and consumers. Rationale Accessing current information easily and quickly is crucial for documenting exposures to dietary supplements because they contain nutrients and other bioactive ingredients that may have beneficial or adverse effects on human health. This manuscript details recent developments with the DSLD to achieve this goal and provides examples of how the DSLD has been used. Recent developments With periodic updates to track changes in product composition and capture new products entering the market, the DSLD currently contains more than 71,000 dietary supplement labels. Following usability testing with consumer and researcher user groups completed in 2016, improvements to the DSLD interface were made. As of 2017, both a desktop and mobile device version are now available. Since its inception in 2008, the use of the DSLD has included research, exposure monitoring, and other purposes by users in the public and private sectors. Future directions Further refinement of the user interface and search features to facilitate ease of use for stakeholders is planned. Conclusions The DSLD can be used to track changes in product composition and capture new products entering the market. With over 71,000 DS labels it is a unique resource that policymakers, researchers, clinicians, and consumers may find valuable for multiple applications.

Launched in 2008, the Dietary Supplement Label Database (DSLD) permits the search of any term that appears anywhere on product labels. Since then, the database's search and download features have been periodically improved to enhance use for researchers and consumers. In this review, we describe how to customize searches and identify products and ingredients of interest to users in the DSLD, and provide the limitations of working with information derived from dietary supplement product labels. This article describes how data derived from information printed on product labels are entered and organized in the DSLD. Among the challenges are determining the chemical forms, types of extract, and amounts of dietary ingredients, especially when these are components of proprietary blends. The FDA announced new dietary supplement labeling regulations in May 2016. The 2017 DSLD has been updated to reflect them. These new regulations and examples cited in this article refer to this redesigned version of the DSLD. Search selection characteristics such as for product type and intended user group are as described in FDA guidance and regulations for dietary supplements. For this reason, some age groups (such as teens and seniors) and marketing recommendations for use (e.g., weight loss, performance, and other disease- or condition-specific claims) are not included in the search selections. The DSLD user interface features will be revised periodically to reflect regulatory and technologic developments to enhance user experience. A comprehensive database derived from analytically verified data on composition would be preferable to label data, but is not feasible for technical, logistic, and financial reasons. Therefore, a database derived from information printed on product labels is the only practical option at present for researchers, clinicians, and consumers interested in the composition of these products.

Objective This review summarizes the current and previous data on dietary supplement (DS) use collected from participants in the National Health and Nutrition Examination Survey (NHANES), describes the NHANES dietary supplement database used to compute nutrient intakes from DSs, discussed recent developments and future direction, and describes many examples to demonstrate the utility of these data in informing nutrition research and policy. Background and history Since 1971, NHANES, has been collecting information on the use of DSs from participants. These data are critical to national nutrition surveillance and have been used to characterize usage patterns, examine trends over time, assess the percentage of the population meeting or exceeding nutrient recommendations, and to help elucidate the sources contributing nutrients to the diet of the US population. Rationale Over half of adults and about one-third of children in the United States use at least one dietary supplement in the past 30 days. Dietary supplements contribute to the dietary intake of nutrients and bioactive compounds in the US and therefore need to be assessed when monitoring nutritional status of the population and when studying diet-health associations. Recent developments With the recent development and availability of the Dietary Supplement Label Database (DSLD), a comprehensive DS database that will eventually contain labels for all products marketed in the US, NHANES DS data will be more easily linked to product information to estimate nutrient intake from DS. Future directions Over time, NHANES has both expanded and improved collection methods. The continued understanding of sources of error in collection methods will continue to be explored and is critical to improved accuracy. Conclusions NHANES provides a rich source of nationally representative data on the usage of dietary supplements in the US.

One in five Americans experiences disability that affects their daily function because of impairments in mobility, cognitive function, sensory impairment, or communication impairment. The need for rehabilitation strategies to optimize function and reduce disability is a clear priority for research to address this public health challenge. The National Institutes of Health (NIH) recently published a Research Plan on Rehabilitation that provides a set of priorities to guide the field over the next 5 years. The plan was developed with input from multiple Institutes and Centers within the NIH, the National Advisory Board for Medical Rehabilitation Research, and the public. This article provides an overview of the need for this research plan, an outline of its development, and a listing of six priority areas for research. The NIH is committed to working with all stakeholder communities engaged in rehabilitation research to track progress made on these priorities and to work to advance the science of medical rehabilitation. This article is being published almost simultaneously in the following six journals: American Journal of Occupational Therapy, American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Neurorehabilitation and Neural Repair, Physical Therapy, and Rehabilitation Psychology. Citation information is as follows: NIH Medical Rehabilitation Coordinating Committee. Am J Phys Med Rehabil. 2017;97(4):404—407.

BACKGROUND: Factor VIIc, fibrinogen, and plasminogen activator inhibitor 1 (PAI-1) are cardiovascular disease (CVD) risk factors and are modulated, in part, by fat type and amount. OBJECTIVE: We evaluated fat type and amount on the primary outcomes: factor VIIc, fibrinogen, and PAI-1. METHODS: In the Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) Trial, 2 controlled crossover feeding studies evaluated substituting carbohydrate or MUFAs for SFAs. Study 1: healthy participants (n = 103) were provided with (8 wk) an average American diet [AAD; designed to provide 37% of energy (%E) as fat, 16% SFA], a Step 1 diet (30%E fat, 9% SFA), and a diet low in SFA (Low-Sat; 26%E fat, 5% SFA). Study 2: participants (n = 85) at risk for CVD and metabolic syndrome (MetSyn) were provided with (7 wk) an AAD, a step 1 diet, and a high-MUFA diet (designed to provide 37%E fat, 8% SFA, 22% MUFA). RESULTS: Study 1: compared with AAD, the Step 1 and Low-Sat diets decreased mean factor VIIc by 1.8% and 2.6% (overall P = 0.0001), increased mean fibrinogen by 1.2% and 2.8% (P = 0.0141), and increased mean square root PAI-1 by 0.0% and 6.0% (P = 0.0037), respectively. Study 2: compared with AAD, the Step 1 and high-MUFA diets decreased mean factor VIIc by 4.1% and 3.2% (overall P

The Office of Dietary Supplements of the NIH convened 3 workshops on iodine nutrition in Rockville, Maryland, in 2014. The purpose of the current article is to summarize and briefly discuss a list of research and resource needs developed with the input of workshop participants. This list is composed of the basic, clinical, translational, and population studies required for characterizing the benefits and risks of iodine supplementation, along with related data, analyses, evaluations, methods development, and supporting activities. Ancillary studies designed to use the participant, biological sample, and data resources of ongoing and completed studies (including those not originally concerned with iodine) may provide an efficient, cost-effective means to address some of these research and resource needs. In the United States, the foremost question is whether neurobehavioral development in the offspring of mildly to moderately iodine-deficient women is improved by maternal iodine supplementation during pregnancy. It is important to identify the benefits and risks of iodine supplementation in all population subgroups so that supplementation can be targeted, if necessary, to avoid increasing the risk of thyroid dysfunction and related adverse health effects in those with high iodine intakes. Ultimately, there will be a need for well-designed trials and other studies to assess the impact of maternal supplementation on neurodevelopmental outcomes in the offspring. However, 2 basic information gaps loom ahead of such a study: the development of robust, valid, and convenient biomarkers of individual iodine status and the identification of infant and toddler neurobehavioral development endpoints that are sensitive to mild maternal iodine deficiency during pregnancy and its reversal by supplementation.

Iodine intake is of contemporary public health interest. The recommended daily iodine intake is 150 µg for most adults, and milk is an important source of iodine in the U.S. diet. Iodine concentration in cow’s milk is affected by diet and iodine supplementation levels, milking sanitation practices, and other factors. Current analytical iodine data in U.S. retail milk are crucial for evaluating population-wide health outcomes related to diet. Samples of whole (3.25% fat), 2%, 1%, and skim (0–0.5% fat) milk were procured from 24 supermarkets across the U.S. using a census-based statistical plan. Iodine was analyzed by inductively coupled plasma mass spectrometry, including certified reference materials and control samples to validate results. No difference in iodine content was found between milkfat levels (F3,69 1.033, p = 0.4). Overall mean (SEM) was 85(5.5) µg/serving (240 mL). However, the 95% prediction interval of 39–185 µg/serving for individual samples indicated high variability among individual samples. Given the recommended 150 µg iodine per day for most adults along with the study mean, one milk serving can provide approximately 57% of daily intake. Researchers, health care professionals, and consumers should be aware of iodine variability in milk, while additional research is needed to investigate the impact of iodine variability factors.

Gout, the most common type of inflammatory arthritis and associated with elevated uric acid levels, is a global burden. “Western” dietary habits and lifestyle, and the resulting obesity epidemic, are often blamed for the increased prevalence of gout. Purine intake has shown the biggest dietary impact on uric acid. To manage this situation, data on the purine content of foods are needed. To assess availability and quality of purine data and identify research gaps, we obtained data for four purine bases (adenine, guanine, hypoxanthine, and xanthine) in foods, alcoholic beverages, and dietary supplements. Data were predominantly from Japan, and very little from the United States. Data quality was examined using a modified version of the USDA Data Quality Evaluation System. Purine values in 298 foods/19 food groups, 15 alcoholic beverages, and 13 dietary supplements were reported. Mean hypoxanthine (mg/100 g) in the soups/sauces group was 112 and mean adenine in poultry organs was 62.4, which were the highest among all groups. Regular beer had the highest adenine (1.63 mg/100 mL) and hypoxanthine (0.96 mg/100 mL) among alcoholic beverages reported. Overall, purine was highest in animal-based products and beer. Data were limited in scope, food descriptions, and quality. Additional studies on purine content in U.S. foods may support gout management.

One in five Americans experiences disability that affects their daily function because of impairments in mobility, cognitive function, sensory impairment, or communication impairment. The need for rehabilitation strategies to optimize function and reduce disability is a clear priority for research to address this public health challenge. The National Institutes of Health (NIH) recently published a Research Plan on Rehabilitation that provides a set of priorities to guide the field over the next 5 years. The plan was developed with input from multiple Institutes and Centers within the NIH, the National Advisory Board for Medical Rehabilitation Research, and the public. This article provides an overview of the need for this research plan, an outline of its development, and a listing of six priority areas for research. The NIH is committed to working with all stakeholder communities engaged in rehabilitation research to track progress made on these priorities and to work to advance the science of medical rehabilitation. This article is being published almost simultaneously in the following six journals: American Journal of Occupational Therapy, American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Neurorehabilitation and Neural Repair, Physical Therapy, and Rehabilitation Psychology. Citation information is as follows: NIH Medical Rehabilitation Coordinating Committee. Am J Phys Med Rehabil. 2017;97(4):404—407.

Background Hormonal status influences haemostatic factors including fibrinogen, factor VII and plasminogen activator inhibitor (PAI-1), and concentrations differ among men, premenopausal and postmenopausal women. This study examines how phases of the menstrual cycle influence variability of fibrinogen, factor VII and PAI-1. Design We studied 103 subjects (39 premenopausal women, 18 postmenopausal women and 46 men) during three, randomized, 8-week energy- and nutrient-controlled experimental diets in the Dietary Effects on Lipids and Thrombogenic Activity (DELTA) Study. Fasting blood samples were collected weekly during the last 4 weeks of each diet period, and haemostatic factors were quantified. Two linear mixed-effects models were used for fibrinogen, factor VII and PAI-1: one to estimate and compare group-specific components of variance, and the other to estimate additional fixed effects representing cyclical functions of day of menstrual cycle in premenopausal women. Results Systematic cyclical variation with day of menstrual cycle was observed for fibrinogen (P

A trans-National Institutes of Health initiative, Nutrition and Dietary Supplement Interventions for Inborn Errors of Metabolism (NDSI-IEM), was launched in 2010 to identify gaps in knowledge regarding the safety and utility of nutritional interventions for the management of inborn errors of metabolism (IEM) that need to be filled with evidence-based research. IEM include inherited biochemical disorders in which specific enzyme defects interfere with the normal metabolism of exogenous (dietary) or endogenous protein, carbohydrate, or fat. For some of these IEM, effective management depends primarily on nutritional interventions. Further research is needed to demonstrate the impact of nutritional interventions on individual health outcomes and on the psychosocial issues identified by patients and their families. A series of meetings and discussions were convened to explore the current United States’ funding and regulatory infrastructure and the challenges to the conduct of research for nutritional interventions for the management of IEM. Although the research and regulatory infrastructure are well-established, a collaborative pathway that includes the professional and advocacy rare disease community and federal regulatory and research agencies will be needed to overcome current barriers.

The NIH Office of Dietary Supplements (ODS) convened 3 workshops on iodine nutrition in 2014, each held in Rockville, Maryland. These workshops were part of the ongoing ODS Iodine Initiative, begun in 2011 in response to concerns that US pregnant women may be at risk of iodine deficiency and that a high fraction of prenatal dietary supplements do not contain the recommended amounts of iodine. The primary purpose of the workshops was to consider the data and resources necessary to evaluate the clinical and public health benefits and risks of maternal iodine supplementation in the United States. The first workshop focused on the assessment of iodine intake, the second focused on the assessment of iodine status, and the third focused on the design and interpretation of clinical trials of maternal iodine supplementation. Here we provide the background of the ODS Iodine Initiative, summarize the 3 workshops held in 2014, and introduce the articles that arose from the workshops and are published in this supplement issue.

The association between renal cell cancer (RCC) and intake of fruit, vegetables and nutrients was examined in a population-based case–control study of 323 cases and 1827 controls; dietary intake was obtained using a mailed questionnaire. Cancer risks were estimated by OR and 95 % CI, adjusting for age, sex, smoking, obesity, hypertension, proxy status, alcohol consumption and dietary fat intake and energy. Intake of vegetables was associated with a decreased risk of RCC (OR 0·5; 95 % CI 0·3, 0·7; Ptrend = 0·002), (top compared to the bottom quartile of intake). When intake of individual nutrients was investigated, vegetable fibre intake was associated with decreased risks (OR 0·4; 95 % CI 0·2, 0·6; P P Pinteraction = 0·001). Among non-smokers, low intake of cruciferous vegetables and fruit fibre was also associated with increased risk of RCC (Pinteraction = 0·03); similar inverse associations were found for β-cryptoxanthin, lycopene and vitamin C. When nutrients were mutually adjusted by backwards regression in these subgroups, only β-cryptoxanthin remained associated with lower RCC risk. These findings deserve further investigation in ongoing prospective studies when sample size becomes sufficient.

The rising rates, high prevalence, and adverse consequences of obesity and diabetes call for new approaches to the complex behaviors needed to prevent and manage these conditions. Virtual reality (VR) technologies, which provide controllable, multisensory, interactive three-dimensional (3D) stimulus environments, are a potentially valuable means of engaging patients in interventions that foster more healthful eating and physical activity patterns. Furthermore, the capacity of VR technologies to motivate, record, and measure human performance represents a novel and useful modality for conducting research. This article summarizes background information and discussions for a joint July 2010 National Institutes of Health — Department of Defense workshop entitled Virtual Reality Technologies for Research and Education in Obesity and Diabetes. The workshop explored the research potential of VR technologies as tools for behavioral and neuroscience studies in diabetes and obesity, and the practical potential of VR in fostering more effective utilization of diabetes- and obesity-related nutrition and lifestyle information. Virtual reality technologies were considered especially relevant for fostering desirable health-related behaviors through motivational reinforcement, personalized teaching approaches, and social networking. Virtual reality might also be a means of extending the availability and capacity of health care providers. Progress in the field will be enhanced by further developing available platforms and taking advantage of VR's capabilities as a research tool for well-designed hypothesis-testing behavioral science. Multidisciplinary collaborations are needed between the technology industry and academia, and among researchers in biomedical, behavioral, pedagogical, and computer science disciplines. Research priorities and funding opportunities for use of VR to improve prevention and management of obesity and diabetes can be found at agency websites (National Institutes of Health: http://grants.nih.gov/grants/guide/index.html ; Department of Defense: www.tatrc.org ).

In the United States, the American Thyroid Association recommends that women take a dietary supplement containing 150 µg of iodine 3 months prior to conception and while pregnant and lactating to support fetal growth and neurological development. We used data from the National Health and Nutrition Examination Survey 2011–2014 to describe the use of dietary supplements with and without iodine in the past 30 days among 2155 non-pregnant, non-lactating (NPNL) women; 122 pregnant women; and 61 lactating women. Among NPNL women, 45.3% (95% Confidence Interval [CI]: 42.0, 48.6) used any dietary supplement and 14.8% (95% CI: 12.7, 16.8) used a dietary supplement with iodine in the past 30 days. Non-Hispanic black and Hispanic women were less likely to use any dietary supplement as well as one with iodine, than non-Hispanic white or non-Hispanic Asian women (p < 0.05). Among pregnant women, 72.2% (95% CI: 65.8, 78.6) used any dietary supplement; however, only 17.8% (95% CI: 11.4, 24.3) used a dietary supplement with iodine. Among lactating women, 75.0% (95% CI: 63.0, 87.0) used a dietary supplement; however, only 19.0% (95% CI: 8.8, 29.2) used a dietary supplement with iodine. Among NPNL women using a supplement with iodine, median daily iodine intake was 75.0 µg. Self-reported data suggests that the use of iodine containing dietary supplements among pregnant and lactating women remains low in contrast with current recommendations.

To address the well-recognized and growing public-health problem of obesity in the U.S., the National Heart, Lung, and Blood Institute (NHLBI) supports a robust portfolio of obesity-related research and translation activities and a trans-NHLBI Obesity Working Group. The NHLBI also has a leadership

Recent epidemic increases in the U.S. prevalence of obesity and diabetes are a consequence of widespread environmental changes affecting energy balance and its regulation. These environmental changes range from exposure to endocrine disrupting pollutants to shortened sleep duration to physical inactivity to excess caloric intake. Overall, we need a better understanding of the factors affecting individual susceptibility and resistance to adverse exposures and behaviors and of determinants of individual response to treatment. Obesity and diabetes prevention will require responding to two primary behavioral risk factors: excess energy intake and insufficient energy expenditure. Adverse food environments (external, nonphysiological influences on eating behaviors) contribute to excess caloric intake but can be countered through behavioral and economic approaches. Adverse built environments, which can be modified to foster more physical activity, are promising venues for community-level intervention. Techniques to help people to modulate energy intake and increase energy expenditure must address their personal situations: health literacy, psychological factors, and social relationships. Behaviorally oriented translational research can help in developing useful interventions and environmental modifications that are tailored to individual needs.

An increased risk of renal cell carcinoma (RCC) has been linked with obesity. However, there is limited information about the contribution of dietary fat and fat-related food groups to RCC risk. A population-based case–control study of 406 cases and 2434 controls aged 40–85 years was conducted in Iowa (1986–89). For 323 cases and 1820 controls from the present study, information on dietary intake from foods high in fat nutrients and other lifestyle factors was obtained using a mailed questionnaire. Cancer risks were estimated by OR and 95 % CI, adjusting for age, sex, smoking, obesity, hypertension, physical activity, alcohol and vegetable intake and tea and coffee consumption. In all nutrient analyses, energy density estimates were used. Dietary nutrient intake of animal fat, saturated fat, oleic acid and cholesterol was associated with an elevated risk of RCC (OR = 1·9, 95 % CI 1·3, 2·9, Ptrend Ptrend Ptrend = 0·01; OR = 1·9, 95 % CI 1·3, 2·8, Ptrend = 0·006, respectively, for the top quartile compared with the bottom quartile of intake). Increased risks were also associated with high-fat spreads, red and cured meats and dairy products (OR = 2·0, 95 % CI 1·4, 3·0, Ptrend = 0·001; OR = 1·7, 95 % CI 1·0, 2·2, Ptrend = 0·01; OR = 1·8, 95 % CI 1·2, 2·7, Ptrend = 0·02; OR = 1·6, 95 % CI 1·1, 2·3, Ptrend = 0·02, respectively). In both the food groups and nutrients, there was a significant dose–response with increased intake. Our data also indicated that the association of RCC with high-fat spreads may be stronger among individuals with hypertension. These findings deserve further investigation in prospective studies.

In BriefPeripheral arterial disease (PAD) is a common atherosclerotic disease affecting the quality of life of > 8 million Americans. PAD is characterized by atherosclerotic stenoses of arteries that supply the lower extremities and is associated with a marked increase in the short-term risk of heart attack, stroke, amputation, and death. Adherence to pharmacological therapies and modification of lifestyle factors, including increasing moderate physical activity along with supervised exercise, smoking cessation, and a healthy dietary intake, are central to the successful management of PAD. The improvement of an adverse cardiovascular risk profile is a proven and crucial strategy to lower the risk of major morbid and mortal events for individuals with PAD.

Renal cell carcinoma (RCC) rates in the US have risen, along with those of obesity and hypertension. We investigated the interactive relationship with obesity and hypertension (HT) through a population-based case-control study of RCC in Iowa consisting of 406 cases and 2434 controls. Data on height and weight at various ages and history of HT were collected and interaction tested by log-likelihood ratio tests. After adjustment, both obesity and HT were independently and interactively associated with increased RCC risk. Hypertensive subjects, obese (BMI ≥ 30) at age 40 were 4.2 (CI: 2.38-6.53) times more likely to develop RCC as normotensive individuals of normal weight (BMI25). A similar interactive pattern was observed for obesity at age 60 (p = 0.02). Interaction with obesity was more evident in women (pinteraction = 0.04 age 40, pinteraction = 0.01 age 60). Our findings suggest that maintaining body weight and/or controlling HT are strategies for preventing RCC.

Energy balance disorders account for a large public health burden. The obesity epidemic in particular is one of the most rapidly evolving public health problems of our day. At present, two-thirds of American adults and one-sixth of American children and adolescents are considered either overweight or obese. Public health concern about obesity is high because of the increased risk and increased mortality of cardiovascular disease, Type 2 diabetes, many forms of cancer, gallbladder disease, and osteoarthritis. These risks increase with the severity of the obesity. Excess adipose tissue, representing fat storage, ultimately derives from an imbalance between energy intake and energy expenditure. Conversely, undesirable and inadvertent loss of body weight and muscle mass, as seen in aging and cachectic states of chronic diseases such as heart failure and cancer, have serious clinical and functional consequences without satisfactory clinical or behavioral solutions. Innovative engineering technologies could help to address unresolved problems in energy balance, intake, and expenditure. Novel sensors, devices, imaging technologies, nanotechnologies, biomaterials, technologies to detect biochemical markers of energy balance, mathematical modeling, systems biology, and other approaches could be developed, evaluated, and leveraged through multidisciplinary collaborations. Engineers, physical scientists, and mathematicians can work with scientists from other relevant disciplines who possess expertise in obesity and nutrition. Furthermore, the possibility of re-engineering the “built environment” to encourage higher levels of physical activity has been suggested as another promising and important approach to which engineers can contribute (see http://www.obesityresearch.nih.gov). Ultimately, systematic application of the “Engineering Approach” can help in developing the needed technologies and tools to facilitate research and eventually support therapeutic advances and behavioral change. This article summarizes important public health concerns related to disordered energy balance and describes research priorities identified at a recent National Science Foundation-National Institutes of Health workshop. Research funding opportunities are described as posted on the NIH Guide to Grants and Contracts (see http://www.nih.gov/grants/guide).

Background.Research has shown less aggressive treatment and poorer control of cardiovascular disease (CVD) risk factors in women than men.Methods.We analyzed sex differences in pharmacotherapy strategies and attainment of goals for hemoglobin A1c (HbA1c), blood pressure (BP), and low density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes and established coronary artery disease enrolled into the BARI 2D trial.Results.Similar numbers of drugs were prescribed in both women and men. Women were less frequent on metformin or sulfonylurea and more likely to take insulin and to be on higher doses of hydroxymethylglutaryl-CoA reductase inhibitors (statins) than men. After adjusting for baseline differences and treatment prescribed, women were less likely to achieve goals for HbA1c (OR = 0.71, 95% CI 0.57, 0.88) and LDL-C (OR = 0.64, 95% CI 0.53, 0.78). More antihypertensives were prescribed to women, and yet BP ≤ 130/80 mmHg did not differ by sex.Conclusions.Women entering the BARI 2D trial were as aggressively treated with drugs as men. Despite equivalent treatment, women less frequently met targets for HbA1c and LDL-C. Our findings suggest that there may be sex differences in response to drug therapies used to treat diabetes, hypertension, and hyperlipidemia.

The role that dietary factors play in preventing heart failure (HF) and in improving prognosis is increasingly recognized, indicating a need for well-grounded guidelines that can provide recommendations for daily nutrient intakes. At present, however, the state of dietary guidance is more satisfactory for persons at risk of HF (Stages A and B) than for those with a diagnosis of HF (Stages C and D). For individuals at risk of HF, a good starting point is provided by governmental and professional society guidance directed at dietary management of cardiovascular risk factors such as hypertension, hyperlipidemia, and obesity. These dietary recommendations are consonant with epidemiologic research suggesting that improving risk factor profiles likely will lower the risk of developing HF. For patients with diagnosed HF, however, little information is available to define optimal nutrient intakes and optimal food patterns. Dietary services have been shown useful in improving clinical outcomes, but nutritional management must be individualized to the patient's needs and must accommodate pharmacologic therapy, multiple co-morbidities, the possible need for nutritional supplements, repeated hospitalizations, salt and fluid retention, voluntary vs. involuntary weight loss, and other nutritional issues relevant to the aged population who comprise the majority of HF patients. Progress in the field will require well-designed clinical investigations addressing nutrient intake, nutrient metabolism, and nutritional status while mindful of the complex pathophysiology of HF.

Dietary intervention studies of human beings produce valuable information regarding dietary effects on biological processes and risk factors for chronic diseases. Using the well-controlled feeding approach, participants consume only foods that have been precisely prepared in a research kitchen, whereas in behavioral counseling studies, participants self-select their foods within guidelines. Because controlled feeding studies meticulously control experimental diets, they are intellectually and logistically challenging to conduct. They afford exciting opportunities for dietetic professionals in designing protocols, developing budgets, and collaborating in multidisciplinary research teams. Research dietitians use food composition data and chemical analysis of menus to prepare research diets with precision. They determine the energy requirements of subjects and adjust diets as required, most often for weight maintenance, throughout the study. All people involved in research must be attentive to the ethical treatment of the study participants while motivating them to adhere to the protocol requirements. Dietitians possess many of these skills, but may require training specific to well-controlled feeding studies. Information related to the conduct of controlled feeding studies has recently become more accessible. We provide an overview of well-controlled feeding study methodologies, proficiencies for planning and implementing these studies, and training resources.

The compelling practical applications of nutrient databases, and the technical challenges in their development, often divert attention from their underlying research basis. Nutrient databases are, in fact, the publications of research projects that draw on the methodology of analytical chemistry, sampling statistics, and information technology in order to answer a core question: “What is the nutrient content of the food supply?” The responsibility for addressing this question, and for conducting the ensuing research, is typically assigned to governmental entities, especially for databases that are reflective of national food supplies. This responsibility reflects the key role of nutrient data in public health decision-making. At their best, nutrient databases can represent an optimal convergence of the characteristics of both “research science,” which seeks to increase knowledge of natural phenomena and processes, and “regulatory science,” which provides the knowledge base needed for policy-making and other government work. These two categories of research have many commonalities, such as their scientific methodology, even though they differ in their sites of performance and affiliated institutions, their operational procedures, and their standards of accountability. A good example of this convergence is found in the National Food and Nutrient Analysis Program and its various ancillary projects (databases on fluoride, choline, phytonutrients, Native American/Alaska Native foods, commodity foods, and dietary supplements). Confirmed validity of the findings, enhanced trust in the results, strengthened political and public support, and funding that underwrites the capacity for high scientific standards, are all potential benefits of acknowledging the simultaneous research and regulatory science aspects of nutrient databases.

The ongoing obesity epidemic and its impending cardiovascular consequences represent a serious public health problem with worrisome implications for medical treatment. The urgency of providing new research directions recently led the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to convene a Working Group on the Pathophysiology of Obesity-Associated Cardiovascular Disease. Gathered at this meeting were researchers with substantial experience and expertise in either obesity-related sciences, including epidemiology, endocrinology, and metabolism, or cardiovascular sciences, including cardiology, neurobiology, hematology, renal function, and pediatrics. This report is the culmination of the blending of ideas during the 2-day meeting. The resulting research recommendations include the development of new models and synergistic approaches to basic studies of obesity-associated cardiovascular diseases. The adult US population, whose combined prevalence of overweight and obesity now exceeds 60%,1 is experiencing an unprecedented exposure to obesity-related cardiovascular risk factors and is expected to suffer the adverse clinical consequences in years to come. Also alarming are the ever-rising rates of overweight and obese children and adolescents, which have tripled over the last 30 years.2 Increased rates of co-morbidities such as dyslipidemia, hypertension, type 2 diabetes, and hepatic damage in overweight adolescents indicate that the young are not protected from the metabolic perturbations that accompany excess adipose tissue stores.3–5⇓⇓ We do not know what the consequences might be for the developing cardiovascular system if obesity is present during late stages of growth and maturation. Overweight or obese individuals experience greatly elevated morbidity and mortality from nearly all of the common cardiovascular diseases (stroke, coronary heart disease, congestive heart failure, cardiomyopathy, and possibly arrhythmia/sudden death).6,7⇓ Because primary treatment and prevention of obesity often fail or are only partially successful, it is anticipated that the …

Lower extremity atherosclerotic peripheral artery disease (PAD) has a very high prevalence in most nations and in the United States.1–8 Lower extremity PAD is now known to be associated with equal morbidity and mortality and comparable (or higher) health economic costs as coronary heart disease (CHD) and ischemic stroke.9,10 Yet where surveyed, the public and clinicians (as well as health payers and government agencies) do not yet fully recognize the risks associated with PAD.11 For decades, clinicians did not recognize the impact of coronary disease in women.12 As such, women were not informed of their CHD risk. For any common disease, whether infectious, oncological, or traumatic, when more than half of the population at risk is not aware of this risk, and when this risk is not managed, preventable morbid and mortal events are inevitable. Certain health facts are now evident: Women suffer the consequences of PAD at rates at least as high as those observed in men. But major knowledge gaps exist. Clinical research to evaluate gender-based differences that might underlie the delayed, postmenopausal presentation of PAD in women has not been conducted. Whether subtle but important gender-based distinctions in clinical presentations exist is unknown. The relative sensitivity and specificity of PAD diagnostic tests and pathways by gender are unclear. Although there is suggestive evidence that treatment benefits and harms are different in women and men, this cannot yet be confirmed from current clinical trial data because of the limited inclusion of women in past investigations. Other facts provide encouragement. Women with or at risk for CHD now better understand this risk. Thus, collation of accurate PAD-specific health information for women is likely to improve their own health and that of society at large. The American Heart Association, in collaboration with …

Two nutrition intervention trials were conducted in Linxian, China, where the esophageal/gastric cardia cancer mortality rates are among the highest in the world and there is suspicion that the population's chronic deficiencies of multiple nutrients are etiologically involved. Both trials were randomized, double-blind, and placebo-controlled, and tested the effect of multiple-vitamin and multiple-mineral supplements in lowering the rates of cancer. In the first trial, the Dysplasia Trial, 3318 individuals with a cytologic diagnosis of esophageal dysplasia received daily vitamin and mineral supplements or placebos for 6 years. The second trial, the General Population Trial, involved 29,584 individuals and used a one-half replicate of a 2(4) fractional factorial design, which enabled the testing of daily supplementation of four different vitamin and mineral combinations and placebo for a period 5 1/4 years. This article describes the design and methods of these studies as well as the baseline characteristics and compliance behavior of the participants in these two trials, the largest cancer chemoprevention studies reported to date.

Background A number of vitamins and minerals have been shown to influence carcinogenesis in experimental animals. In humans, epidemiologic evidence suggests that intake of fruits and vegetables may reduce risk of esophageal and other cancers. Vitamins and minerals in these foods may contribute to the reduced cancer risk. The people of Linxian, China, have persistently low intake of multiple nutrients and exhibit one of the world's highest rates of esophageal/gastric cardia cancer, with an exceptionally high risk of esophageal dysplasia. Purpose To determine whether supplementation with multiple vitamins and minerals may reduce esophageal/gastric cardia cancer among persons with esophageal dysplasia, we conducted a 6-year prospective intervention trial in Linxian. Methods Mortality and cancer incidence were ascertained from May 1985 through May 1991 for 3318 persons with cytologic evidence of esophageal dysplasia who were randomly assigned to receive, throughout that period, daily supplementation with 14 vitamins and 12 minerals or placebo. Doses were typically two to three times U.S. Recommended Daily Allowances. Compliance was assessed by counting unused pills monthly for all trial participants and by assaying nutrient levels in blood collected from samples of individuals randomly selected without replacement every 3 months throughout the trial. Cancers were identified through routine surveillance and by special cytology and endoscopy screenings after 2 1/2 years and 6 years. Results A total of 324 deaths occurred during the 6-year intervention period; 167 occurred in the control (placebo) group and 157 occurred in the supplement group. Cancer was the leading cause of death (54% of all deaths); 18% were due to cerebrovascular diseases and 29% to other causes. Cumulative esophageal/gastric cardia death rates were 8% lower (relative risk [RR] = 0.92; 95% confidence interval [CI] = 0.67-1.28) among individuals receiving supplements rather than placebo, a nonsignificant (P > .10) difference. Risk of total mortality was 7% lower (RR = 0.93; 95% CI = 0.75-1.16; P > .10), total cancer 4% lower (RR = 0.96; 95% CI = 0.71-1.29; P > .10), cerebrovascular disease 38% lower (RR = 0.62; 95% CI = 0.37-1.06; P = .08), and other diseases 12% higher (RR = 1.12; 95% CI = 0.74-1.69; P > .10) among the treated group. Cumulative cancer incidence rates were nearly the same in the two groups. Conclusions No substantial short-term beneficial effect on incidence or mortality for this type of cancer occurred following daily supplementation with multiple vitamins and minerals among adults with precancerous lesions of the esophagus. Implications Although no statistically significant short-term benefits were observed, longer follow-up should be more informative about the effectiveness of this 6-year supplementation on cancer and other diseases among individuals with esophageal dysplasia.

We used data from a study of racial differences in cancer patient survival to examine the association between estrogen receptor status and the intake of nutrients and food groups among 689 black and white women, ages 20-79, with breast cancer newly diagnosed in 1985 and 1986. We reviewed medical records and collected interview data, including a 34-item food frequency questionnaire. Consistent with published reports, we found positive estrogen receptor status to be positively associated with age and inversely associated with parity and oral contraceptive use. Whites were more likely than blacks to have estrogen receptor-positive tumors. We examined eight nutrients and six food groups in multivariate analyses for association with estrogen receptor status. After adjusting for age, race, usual body mass index, and parity, a high percentage of calories from fat was associated with estrogen receptor-positive cancer, and a high percentage of calories from carbohydrates was associated with estrogen receptor-negative breast cancer. These findings indicate that women with breast cancer who are on diets with a high percentage of calories from fat may be more likely to develop estrogen receptor-positive cancers.

Abstract The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Thyroid nodularity following continuous low-dose radiation exposure in China was determined in 1,001 women aged 50-65 years who resided in areas of high background radiation (330 mR/yr) their entire lives, and in 1,005 comparison subjects exposed to normal levels of radiation (114 mR/yr). Cumulative doses to the thyroid were estimated to be of the order of 14 cGy and 5 cGy, respectively. Personal interviews and physical examinations were conducted, and measurements were made of serum thyroid hormone levels, urinary iodine concentrations, and chromosome aberrations in circulating lymphocytes. For all nodular disease, the prevalences in the high background and control areas were 9.5% and 9.3%, respectively. For single nodules, the prevalences were 7.4% in the high background area and 6.6% in the control area (prevalence ratio = 1.13; 95% confidence interval = 0.82-1.55). There were no differences found in serum levels of thyroid hormones. Women in the high background region, however, had significantly lower concentrations of urinary iodine and significantly higher frequencies of stable and unstable chromosome aberrations. Increased intake of allium vegetables such as garlic and onions was associated with a decreased risk of nodular disease, which seems consistent with experimental studies suggesting that allium compounds can inhibit tumor growth and proliferation. The prevalence of mild diffuse goiter was higher in the high background radiation region, perhaps related to a low dietary intake of iodine. These data suggest that continuous exposure to low-level radiation throughout life is unlikely to appreciably increase the risk of thyroid cancer. However, such exposure may cause chromosomal damage.

Background: In subjects with a high prevalence of metabolic risk abnormalities, the preferred replacement for saturated fat is unresolved. Objective: The objective was to study whether carbohydrate or monounsaturated fat is a preferred replacement for saturated fat. Design: Fifty-two men and 33 women, selected to have any combination of HDL cholesterol ≤ 30th percentile, triacylglycerol ≥ 70th percentile, or insulin ≥ 70th percentile, were enrolled in a 3-period, 7-wk randomized crossover study. The subjects consumed an average American diet (AAD; 36% of energy from fat) and 2 additional diets in which 7% of energy from saturated fat was replaced with either carbohydrate (CHO diet) or monounsaturated fatty acids (MUFA diet). Results: Relative to the AAD, LDL cholesterol was lower with both the CHO (-7.0%) and MUFA (-6.3%) diets, whereas the difference in HDL cholesterol was smaller during the MUFA diet (-4.3%) than during the CHO diet (-7.2%). Plasma triacylglycerols tended to be lower with the MUFA diet, but were significantly higher with the CHO diet. Although dietary lipid responses varied on the basis of baseline lipid profiles, the response to diet did not differ between subjects with or without the metabolic syndrome or with or without insulin resistance. Postprandial triacylglycerol concentrations did not differ significantly between the diets. Lipoprotein(a) concentrations increased with both the CHO (20%) and MUFA (11%) diets relative to the AAD. Conclusions: In the study population, who were at increased risk of coronary artery disease, MUFA provided a greater reduction in risk as a replacement for saturated fat than did carbohydrate.

Background: Nutrition research has the potential to identify better ways of preventing andmanaging heart failure, leading to reduced costs and better patient outcomes. However, it has proved especially challenging to design well-powered clinical efficacy and ffectiveness studies in this field.Methods: To better understand the federal heart failure-related research support provided to date, and to identify issues that must be addressed by applicants, we present the results of a portfolio analysis based on search results from the Federal RePORTER database. The search was limited to funded projects for the fiscal years 2000-2014 where the terms “nutrition or diet or dietary supplements” and “heart failure” were included in the abstract, key words, or title. Results: Approximately 60 projects were funded during this time period, themajority being supported through research project grants (R mechanisms) and a smaller number through training awards (F or K mechanisms). Most of the support was provided by three NIH Institutes (NHLBI, NINR, and NIA) and by the Office of Dietary Supplements. The main types of funded science were basic studies in animal models, mechanistic physiology studies in humans, and longitudinal or cross-sectional observational cohort studies. Therewere relatively few intervention studies, withmost evaluating behavioral change and education modalities. The trials that compared dietary treatments generally were small proof-of-concept or pilot studies. Nutrition research typically comprises w5% of the NIH research investment in most years (for example, $1.6B/$30B in 2014); heart failure has a very low profile within the NIH nutrition research portfolio (for example, approximately $4M/$1.6B, or 0.2% in 2014). Conclusion: Nutrition issues and diet interventions are understudied in heart failure patients. All types of research are needed, particularly well-designed clinical efficacy and effectiveness trials. Submission strategies and funding opportunities that can be considered for closing data gaps related to the ongoing epidemic of heart failure will be discussed.

The nature of the association between alcohol consumption and renal cell carcinoma (RCC) is not well understood, but there are indications of effect modification by gender. The authors report data from a population-based case-control study conducted in Iowa from 1986 to 1989. RCC cases (261 men and 145 women) were identified through the Iowa Cancer Registry, while controls (1,598 men and 831 women) were randomly selected from the general population, frequency matched on age and gender. Subjects provided detailed information on a mailed questionnaire regarding demographic, anthropometric, lifestyle, dietary, and medical history risk factors. In age-adjusted analysis, there was a decrease in risk for women who reported consuming more than three servings (median among drinkers) of alcohol per week (odds ratio = 0.5, 95% confidence interval: 0.2, 0.9) compared with never drinkers. No evidence of an association among men was noted (odds ratio = 1.1, 95% confidence interval: 0.8, 1.5). Multivariate adjustment for anthropometric, lifestyle, smoking, and dietary factors did not alter the findings. Analysis by type of alcohol suggested that the inverse association was strongest for beer consumption, but estimates were imprecise. These findings suggest an inverse association of alcohol consumption and RCC development among women but not among men.

Objective This study examined the accuracy of a multiplepass, 24 hour dietary recall method for estimating energy intakes of men and women by comparing it with energy intake required for weight maintenance. Design Threeday, multiplepass, 24-hour recalls were obtained on randomly selected days during a selfselected diet period when subjects were preparing their own meals and during a controlled diet period when all meals were provided by the study. During the dietary intervention, weight was maintained; body weight and dietary intake were monitored closely, thereby allowing estimation of the energy intake required for weight maintenance. Subjects/setting Seventyeight men and women (22 to 67 years old) from the Dietary Effects on Lipoprotein and Thrombogenic Activity (DELTA) study participated in this study. All 24-hour recalls were collected using a computerassisted, interactive, multiplepass telephone interview technique. Energy requirements for each individual were determined by the energy content of the DELTA study foods provided to maintain weight. Statistical analysis Paired and independent t tests were conducted to examine differences among study variables. Agreement between recalled energy intake and weight maintenance energy intake was analyzed using the BlandAltman technique. Results Compared with weight maintenance energy intake, during the selfselected diet period men and women underestimated energy intake by 11% and 13%, respectively. During the controlled diet period, men underestimated energy intake by 13%, whereas women overestimated energy by 1.3%. Applications/conclusions Men had a tendency to underestimate energy intake irrespective of the recording period. The accuracy of the recalled energy intake of women may be influenced by recording circumstances. Researchers should examine the factors influencing underreporting and overreporting by individuals and their impact on macronutrient and micronutrient intakes. Also, strategies need to be developed to minimize underreporting and overreporting. J Am Diet Assoc. 2000; 100:303-308,311.

Abstract —Few well-controlled diet studies have investigated the effects of reducing dietary saturated fatty acid (SFA) intake in premenopausal and postmenopausal women or in blacks. We conducted a multicenter, randomized, crossover-design trial of the effects of reducing dietary SFA on plasma lipids and lipoproteins in 103 healthy adults 22 to 67 years old. There were 46 men and 57 women, of whom 26 were black, 18 were postmenopausal women, and 16 were men ≥40 years old. All meals and snacks, except Saturday dinner, were prepared and served by the research centers. The study was designed to compare three diets: an average American diet (AAD), a Step 1 diet, and a low-SFA (Low-Sat) diet. Dietary cholesterol was constant. Diet composition was validated and monitored by a central laboratory. Each diet was consumed for 8 weeks, and blood samples were obtained during weeks 5 through 8. The compositions of the three diets were as follows: AAD, 34.3% kcal fat and 15.0% kcal SFA; Step 1, 28.6% kcal fat and 9.0% kcal SFA; and Low-Sat, 25.3% kcal fat and 6.1% kcal SFA. Each diet provided ≈275 mg cholesterol/d. Compared with AAD, plasma total cholesterol in the whole group fell 5% on Step 1 and 9% on Low-Sat. LDL cholesterol was 7% lower on Step 1 and 11% lower on Low-Sat than on the AAD (both P P

A case-control investigation involving interviews with 564 stomach cancer patients and 1131 population-based controls was conducted to evaluate reasons for the exceptionally high rates of stomach cancer in Linqu, a rural county in Shandong Province in northeast China. Daily consumption of sour pancakes, a fermented indigenous staple, was associated with a 30% increase in risk. Risks of stomach cancer were also increased by 2- to 3-fold among persons with prior chronic gastritis or gastric ulcer, by 80% among those with stomach cancer in a family member, by 50% among men who smoked one or more packs of cigarettes/day, by 40% among those who preferred salty foods, and by 50% among families with moldy grain supplies. In contrast, risks tended to decrease in proportion to increasing consumption of fresh vegetables and fruits. This protective effect was more pronounced for vegetables, with those in the highest quartile of intake at less than one-half the risk of those in the lowest. Stomach cancer risks also declined with increasing dietary intake of carotene, vitamin C, and calcium, but not retinol. These findings provide leads to dietary factors that contribute to the high rates in Linqu, where stomach cancer is the leading cause of cancer and has not yet begun to decline as in other parts of the world.

Objective To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoproteins and hemostasis parameters in various demographic groups. Design DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37% of energy from fat, 16% of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30% of energy from fat, 9% of energy from SFA; and diet C (low SFA diet) was designed to provide 26% of energy from fat, 5% of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods—especially sources of fat and cholesterol—and use of standardized written procedures. Setting For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. Statistical analyses Means (±standard error) were calculated and compared with target nutrient specifications. Results DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. Applications Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study. J Am Diet Assoc. 1998;98:766–776 .

A population-based case-control study of oral and pharyngeal cancer conducted in four areas of the United States provided information on a number of risk factors, including diet. Interviews were obtained from 871 oral cancer patients and 979 controls among whites, frequency matched for age and sex. Consumption frequency of 61 food items was assessed in the questionnaire; attention was given to foods that are sources of vitamins A and C and carotene. The major finding was an inverse relationship between fruit intake and risk of oral and pharyngeal cancer; individuals in the highest quartile of intake had about half the risk of those in the lowest quartile. Vitamin C, carotene, or fiber in fruit did not appear to account completely for this relationship, since these nutrients in vegetables did not provide similar protection. This finding suggests the influence of other constituents in fruits, although it is possible that cooking vegetables may have a nutrient-diminishing effect. Dietary intake of other nutrients, such as the B vitamins, vitamin E, folate, and iron, showed no consistent relationship to risk of oral and pharyngeal cancer. Coffee or other hot beverage consumption did not increase risk; intake of nitrite-containing meats or cooking practices, such as smoking, pickling, or charcoal grilling, also did not increase risk. All analyses were adjusted for the effects of tobacco and alcohol, strong risk factors for oral and pharyngeal cancer. Dietary findings among the few subjects who did not use tobacco or alcohol were similar to those for all subjects.