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Controversy and Debate: Memory based Methods Paper 4
... Given the fictional discourse on diet-disease relations and the escalating debate over the validity of M-BMs (16,17,(61)(62)(63)(64), the purpose of this critical analysis is to present evidence that the current controversies regarding diet-disease relations are not driven by legitimate differences in scientific inference on the physiologic effects of dietary intake (i.e., consumed foods and beverages). Rather, we contend that current confusion on the putative health effects of dietary sugar, salt, fat, and cholesterol were engendered by a fictional discourse on diet-disease relations created by deeply flawed, demonstrably misleading, and pseudoscientific nutrition epidemiologic reports (9, 15-17, 20, 21, 23, 55). ...
... Most recently, the Journal of Clinical Epidemiology published a series of "Controversy and Debate" articles on the "Fatal Flaws of Food Frequency Questionnaires. . . " (16,17,63,64). In our target paper (17), we presented a number of very specific challenges to the status quo in nutrition epidemiology. ...
... In our target paper (17), we presented a number of very specific challenges to the status quo in nutrition epidemiology. Nevertheless, our esteemed opponents in the debate failed to address the issues and chose to offer mere ipse dixit statements and fallacious arguments (e.g., ignoratio elenchi, ad hominems, ad populum) (63,64). Thus, in our closing statement we wrote that improving nutrition science and public health policy will be achieved only if the epidemiologic research community acknowledges and addresses contrary evidence and empirical refutations (16). ...
Controversies regarding the putative health effects of dietary sugar, salt, fat, and cholesterol are not driven by legitimate differences in scientific inference from valid evidence, but by a fictional discourse on diet-disease relations driven by decades of deeply flawed and demonstrably misleading epidemiologic research. Over the past 60 years, epidemiologists published tens of thousands of reports asserting that dietary intake was a major contributing factor to chronic non-communicable diseases despite the fact that epidemiologic methods do not measure dietary intake. In lieu of measuring actual dietary intake, epidemiologists collected millions of unverified verbal and textual reports of memories of perceptions of dietary intake. Given that actual dietary intake and reported memories of perceptions of intake are not in the same ontological category, epidemiologists committed the logical fallacy of “Misplaced Concreteness.” This error was exacerbated when the anecdotal (self-reported) data were impermissibly transformed (i.e., pseudo-quantified) into proxy-estimates of nutrient and caloric consumption via the assignment of “reference” values from databases of questionable validity and comprehensiveness. These errors were further compounded when statistical analyses of diet-disease relations were performed using the pseudo-quantified anecdotal data. These fatal measurement, analytic, and inferential flaws were obscured when epidemiologists failed to cite decades of research demonstrating that the proxy-estimates they created were often physiologically implausible (i.e., meaningless) and had no verifiable quantitative relation to the actual nutrient or caloric consumption of participants. In this critical analysis, we present substantial evidence to support our contention that current controversies and public confusion regarding diet-disease relations were generated by tens of thousands of deeply flawed, demonstrably misleading, and pseudoscientific epidemiologic reports. We challenge the field of nutrition to regain lost credibility by acknowledging the empirical and theoretical refutations of their memory-based methods and ensure that rigorous (objective) scientific methods are used to study the role of diet in chronic disease.
... However arguments against self-reported information sometimes show a lack of understanding of basic principles in epidemiology. 23,24 We observed a high response rate on birth information (over 99% for birth weight and gestational age). The differences observed between the participants in the validation sample and the rest of the children in the SENDO project do not affect the interpretation and validity of the results, as they are not related to parents' capacity of reporting birth information data. ...
Objective:
To test the validity of parent-reported birth information obtained through an online, self-administered questionnaire.
Method:
The SENDO project is a prospective and dynamic paediatric cohort of Spanish children aged 4 to 6 years old at recruitment. Objective data from medical birth records were compared to parent-reported data getting intra-class correlation coefficients (ICC) for quantitative variables and weighted Kappa Index for qualitative ones. Percentage of responders and of total agreement was also evaluated.
Results:
Parental response rate was over 99% for birth weight and gestational age and 76% for birth length. ICC for birth weight was 0.95 (95% confidence interval [95%CI]: 0.94-0.96) and 0.78 (95%CI: 0.73-0.83) for birth length, both showing very high correlations. The total agreement percentage for gestational age was 97%, and Kappa weighted index was 0.90 (95%CI: 0.89-0.90), showing a very high agreement as well.
Conclusions:
We found high correlations and excellent agreement in parent-reported birth data 4 to 6 years after delivery. Our results show parent-reported birth data, especially birth weight, are valid for use in epidemiological research.
... Two commentaries extend the fascinating controversy and debate covered by four recent articles [5][6][7][8] in the December 2018 issue on the merits or flaws in memory based methods for assessing dietary intake. Barnes tackles this by partitioning each argument into two principal components: data and claim. ...
... However, the validity of self-reported data obtained via such memory-based dietary assessment methods, and hence the whole value of nutrition epidemiology, is being challenged based on their purported inability to correctly reflect true food and nutrient consumption [4][5][6][7]. However, others have argued that despite recognized limitations, relying on self-reported dietary intake data in epidemiological studies has been instrumental in developing impactful dietary guidelines and recommendations over the years [1,2,[7][8][9][10]. One of the fundamental issues in this heated debate relates to whether 24HRs and FFQs can measure true energy intake, due among other factors to significant random and systematic errors [1,[11][12][13][14]. ...
Traditional food frequency questionnaires (FFQs) are influenced by systematic error, but web-based FFQ (WEB-FFQs) may mitigate this source of error. The objective of this study was to compare the accuracy of interview-based and web-based FFQs to assess energy requirements (mERs). The mER was measured in a series of controlled feeding trials in which participants daily received all foods and caloric drinks to maintain stable body weight over 4 to 6 weeks. FFQs assessing dietary intakes and hence mean energy intake were either interviewer-administered by a registered dietitian (IA-FFQ, n = 127; control method) or self-administered using a web-based platform (WEB-FFQ, n = 200; test method), on a single occasion. Comparison between self-reported energy intake and mER revealed significant under-reporting with the IA-FFQ (−9.5%; 95% CI, −12.7 to −6.1) and with the WEB-FFQ (−11.0%; 95% CI, −15.4 to −6.4), but to a similar extent between FFQs (p = 0.62). However, a greater proportion of individuals were considered as accurate reporters of energy intake using the IA-FFQ compared with the WEB-FFQ (67.7% vs. 48.0%, respectively), while the prevalence of over-reporting was lower with the IA-FFQ than with the WEB-FFQ (6.3% vs. 17.5%, respectively). These results suggest less accurate prediction of true energy intake by a self-administered WEB-FFQ than with an IA-FFQ.
Objective:
to analyze the validity of self-reported somatometry data through a self-reported online questionnaire.
Method:
the SENDO project (Follow-up of Children for Optimal Development) is a prospective, dynamic pediatric cohort. Participants are recruited when they are between 4 and 6 years old, and followed annually through an online questionnaire. In a subsample of 82 participants, we compared the anthropometric information reported in the baseline questionnaire with the direct measurements collected by the investigating staff. To do this, we calculated the intraclass correlation index (ICC) and the Bland-Altman coefficient.
Results:
the ICC was 0.96 (95 % confidence interval [CI]: 0.94-0.98 for weight; 0.95 (95 % CI: 0.92-0.96) for height; 0.75 (95 % CI: 0.64-0.86) for waist circumference; and 0.84 (95 % CI: 0.76-0.89) for hip circumference. In relation to the indices calculated from these measurements, we found an ICC of 0.84 (95 % CI: 0.77-0.90) for body mass index; 0.46 (95 % CI: 0.27-0.62) for waist-hip ratio; and 0.59 (95 % CI: 0.43-0.72) for waist-height index. The Bland-Altman index ranged from 3.7 % for weight to 8.5 % for body mass index.
Conclusions:
we found a high correlation and concordance between the data collected in the physical exam and those reported by the parents. Our results indicate that the anthropometric measures provided by parents, especially those with which they are most familiar, are valid and can be used in epidemiological research.
Introduction:
currently, it is important to determine whether food frequency questionnaires (FFQ) are valid tools to collect information on usual diet in children.
Objective:
we evaluated the reproducibility and validity of the semi-quantitative FFQ used in a Spanish cohort of children aged 4-7 years.
Methods:
to explore its reproducibility, parents filled a 138-item FFQ at baseline (FFQ-0) and then one year later (FFQ-1). To explore its validity, the FFQ-1 was compared with four weighed 3-day dietary records (DRs) that were used as standard of reference. To estimate associations we calculated deattenuated Pearson's correlation coefficients to correct for season-to-season variability, and the Bland-Altman index. We also calculated the weighted kappa index and assessed participant's gross misclassification across quintiles. We analyzed data from 67 (for reproducibility) and 37 (for validity) children aged 4-7 years old, recruited by the pilot study of the SENDO project.
Results:
regarding reproducibility, we found mean Bland-Altman indexes of 0-10.45 % for nutrients and 1.49 %-10.45 % for foods. The adjusted r ranged between 0.29 and 0.71, and between 0.27 and 0.74 for nutrients and foods, respectively. Regarding validity, we found mean Bland-Altman indexes of 0 %-16.22 % and 0 %-10.81 % for nutrients and for food groups, respectively. The deattenuated r ranged between 0.38 and 0.81 for nutrients, and between 0.53 and 0.68 for foods. The weighted kappa index for agreement across quintiles ranged from 54.1 to 85.1 for nutrients, and from 55.4 to 78.4 for food groups.
Conclusions:
our results showed acceptable levels of both reproducibility and validity, and that the ad-hoc developed FFQ is a valid tool for assessing usual diet in Spanish preschoolers.
Two recent commentaries published in this journal argued against the usefulness of memory-based dietary assessment methods (M-BMs). A pair of responding commentaries disputed those negative claims regarding M-BMs and defended the usefulness of M-BMs. This article is intended to clarify the claims made in the four commentaries cited previously, identify the manner in which those claims have been supported, and suggest possible ways forward. In service of the goals of this article, I have identified the main arguments found in each of the four commentaries cited previously. I then partitioned each argument into two principle components: data and claim. I then identified the type of data used to support each claim. Finally, I have identified some of the potential reasons for the disagreements between the two parties and have suggested potential opportunities for progress on the issues at the heart of the controversy.
Objective
To (i) evaluate the extent to which Coca-Cola’s ‘Transparency Lists’ of 218 researchers that it funds are comprehensive; (ii) map all scientific research acknowledging funding from Coca-Cola; (iii) identify those institutions, authors and research topics funded by Coca-Cola; and (iv) use Coca-Cola’s disclosure to gauge whether its funded researchers acknowledge the source of funding.
Design
Using Web of Science Core Collection database, we retrieved all studies declaring receipt of direct funding from the Coca-Cola brand, published between 2008 and 2016. Using conservative eligibility criteria, we iteratively removed studies and recreated Coca-Cola’s transparency lists using our data. We used network analysis and structural topic modelling to assess the structure, organization and thematic focus of Coca-Cola’s research enterprise, and string matching to evaluate the completeness of Coca-Cola’s transparency lists.
Results
Three hundred and eighty-nine articles, published in 169 different journals, and authored by 907 researchers, cite funding from The Coca-Cola Company. Of these, Coca-Cola acknowledges funding forty-two authors (<5 %). We observed that the funded research focuses mostly on nutrition and emphasizes the importance of physical activity and the concept of ‘energy balance’.
Conclusions
The Coca-Cola Company appears to have failed to declare a comprehensive list of its research activities. Further, several funded authors appear to have failed to declare receipt of funding. Most of Coca-Cola’s research support is directed towards physical activity and disregards the role of diet in obesity. Despite initiatives for greater transparency of research funding, the full scale of Coca-Cola’s involvement is still not known.
Background
Several statistical approaches have been proposed to assess and correct for exposure measurement error. We aimed to provide a critical overview of the most common approaches used in nutritional epidemiology.
Methods
MEDLINE, EMBASE, BIOSIS and CINAHL were searched for reports published in English up to May 2016 in order to ascertain studies that described methods aimed to quantify and/or correct for measurement error for a continuous exposure in nutritional epidemiology using a calibration study.
Results
We identified 126 studies, 43 of which described statistical methods and 83 that applied any of these methods to a real dataset. The statistical approaches in the eligible studies were grouped into: a) approaches to quantify the relationship between different dietary assessment instruments and “true intake”, which were mostly based on correlation analysis and the method of triads; b) approaches to adjust point and interval estimates of diet-disease associations for measurement error, mostly based on regression calibration analysis and its extensions. Two approaches (multiple imputation and moment reconstruction) were identified that can deal with differential measurement error.
Conclusions
For regression calibration, the most common approach to correct for measurement error used in nutritional epidemiology, it is crucial to ensure that its assumptions and requirements are fully met. Analyses that investigate the impact of departures from the classical measurement error model on regression calibration estimates can be helpful to researchers in interpreting their findings. With regard to the possible use of alternative methods when regression calibration is not appropriate, the choice of method should depend on the measurement error model assumed, the availability of suitable calibration study data and the potential for bias due to violation of the classical measurement error model assumptions. On the basis of this review, we provide some practical advice for the use of methods to assess and adjust for measurement error in nutritional epidemiology.
Electronic supplementary material
The online version of this article (10.1186/s12874-017-0421-6) contains supplementary material, which is available to authorized users.
NHANES is the cornerstone for national nutrition monitoring to inform nutrition and health policy. Nutritional assessment in NHANES is described with a focus on dietary data collection, analysis, and uses in nutrition monitoring. NHANES has been collecting thorough data on diet, nutritional status, and chronic disease in cross-sectional surveys with nationally representative samples since the early 1970s. Continuous data collection began in 1999 with public data release in 2-y cycles on ∼10,000 participants. In 2002, the Continuing Survey of Food Intakes by Individuals and the NHANES dietary component were merged, forming a consolidated dietary data collection known as What We Eat in America; since then, 24-h recalls have been collected on 2 d using the USDA's Automated Multiple-Pass Method. Detailed and targeted food-frequency questionnaires have been collected in some NHANES cycles. Dietary supplement use data have been collected (in detail since 2007) so that total nutrient intakes can be described for the population. The continuous NHANES can adapt its content to address emerging public health needs and reflect federal priorities. Changes in data collection methods are made after expert input and validation/crossover studies. NHANES dietary data are used to describe intake of foods, nutrients, food groups, and dietary patterns by the US population and large sociodemographic groups to plan and evaluate nutrition programs and policies. Usual dietary intake distributions can be estimated after adjusting for day-to-day variation. NHANES remains open and flexible to incorporate improvements while maintaining data quality and providing timely data to track the nation's nutrition and health status. In summary, NHANES collects dietary data in the context of its broad, multipurpose goals; the strengths and limitations of these data are also discussed in this review.
Recent reports have asserted that, because of energy underreporting, dietary self-report data suffer from measurement error so great that findings that rely on them are of no value. This commentary considers the amassed evidence that shows that self-report dietary intake data can successfully be used to inform dietary guidance and public health policy. Topics discussed include what is known and what can be done about the measurement error inherent in data collected by using self-report dietary assessment instruments and the extent and magnitude of underreporting energy vs. other nutrients and food groups. Also discussed is the overall impact of energy underreporting on dietary surveillance and nutritional epidemiology. In conclusion, 7 specific recommendations for collecting, analyzing, and interpreting self-report dietary data are provided: 1) continue to collect self-report dietary intake data because they contain valuable, rich, and critical information about foods and beverages consumed by populations that can be used to inform nutrition policy and assess diet-disease associations; 2) do not use self-reported energy intake as a measure of true energy intake; 3) do use self-reported energy intake for energy adjustment of other self-reported dietary constituents to improve risk estimation in studies of diet-health associations; 4) acknowledge the limitations of self-report dietary data and analyze and interpret them appropriately; 5) design studies and conduct analyses that allow adjustment for measurement error; 6) design new epidemiologic studies to collect dietary data from both short-term (recalls or food records) and long-term (food-frequency questionnaires) instruments on the entire study population to allow for maximizing the strengths of each instrument; and 7) continue to develop, evaluate, and further expand methods of dietary assessment, including dietary biomarkers and methods using new technologies.
Objectives To examine the prospective associations between consumption of sugar sweetened beverages, artificially sweetened beverages, and fruit juice with type 2 diabetes before and after adjustment for adiposity, and to estimate the population attributable fraction for type 2 diabetes from consumption of sugar sweetened beverages in the United States and United Kingdom.
Design Systematic review and meta-analysis.
Data sources and eligibility PubMed, Embase, Ovid, and Web of Knowledge for prospective studies of adults without diabetes, published until February 2014. The population attributable fraction was estimated in national surveys in the USA, 2009-10 (n=4729 representing 189.1 million adults without diabetes) and the UK, 2008-12 (n=1932 representing 44.7 million).
Synthesis methods Random effects meta-analysis and survey analysis for population attributable fraction associated with consumption of sugar sweetened beverages.
Results Prespecified information was extracted from 17 cohorts (38 253 cases/10 126 754 person years). Higher consumption of sugar sweetened beverages was associated with a greater incidence of type 2 diabetes, by 18% per one serving/day (95% confidence interval 9% to 28%, I2 for heterogeneity=89%) and 13% (6% to 21%, I2=79%) before and after adjustment for adiposity; for artificially sweetened beverages, 25% (18% to 33%, I2=70%) and 8% (2% to 15%, I2=64%); and for fruit juice, 5% (−1% to 11%, I2=58%) and 7% (1% to 14%, I2=51%). Potential sources of heterogeneity or bias were not evident for sugar sweetened beverages. For artificially sweetened beverages, publication bias and residual confounding were indicated. For fruit juice the finding was non-significant in studies ascertaining type 2 diabetes objectively (P for heterogeneity=0.008). Under specified assumptions for population attributable fraction, of 20.9 million events of type 2 diabetes predicted to occur over 10 years in the USA (absolute event rate 11.0%), 1.8 million would be attributable to consumption of sugar sweetened beverages (population attributable fraction 8.7%, 95% confidence interval 3.9% to 12.9%); and of 2.6 million events in the UK (absolute event rate 5.8%), 79 000 would be attributable to consumption of sugar sweetened beverages (population attributable fraction 3.6%, 1.7% to 5.6%).
Conclusions Habitual consumption of sugar sweetened beverages was associated with a greater incidence of type 2 diabetes, independently of adiposity. Although artificially sweetened beverages and fruit juice also showd positive associations with incidence of type 2 diabetes, the findings were likely to involve bias. None the less, both artificially sweetened beverages and fruit juice were unlikely to be healthy alternatives to sugar sweetened beverages for the prevention of type 2 diabetes. Under assumption of causality, consumption of sugar sweetened beverages over years may be related to a substantial number of cases of new onset diabetes.
Dear Editor,
We write in response to a recent letter to the Editor entitled “Implausible Data, False Memories, and the Status Quo in Dietary Assessment” by Archer and Blair (1). Although we disagree with some other aspects of their letter, we confine ourselves here to the portion of the letter in which the authors cite data from our recently published article (2). The authors claim that our data “demonstrate the futility” of self-report dietary data methods. They cite estimates of squared average correlation between true usual energy intake and self-reported energy intake of between 0.04 and 0.10, stating that these values “provide unequivocal evidence that self-report dietary data offer an inadequate basis from which to draw scientific conclusions.”
We strongly disagree with their conclusions. It does not follow logically that because energy intake is poorly estimated by self-reporting methods, self-report dietary data can never be used to establish scientifically valid conclusions. Archer and Blair ignore 2 of our findings. First, FFQ-reported protein density (protein intake divided by energy intake) has a far higher correlation with true usual intake than does protein itself. This same finding was also evident for potassium and sodium, as well as for the sodium-potassium ratio (3). Increased correlations are also seen with 24-h recall reported intake after forming densities. These findings indicate that self-report instruments are more suited to the elicitation of a person’s dietary composition than his or her absolute intake. This has long been recognized within the nutritional epidemiology community, and it has led to the common practice of energy adjustment (4) when analyzing self-reported intake of nutrients and food groups. In a similar vein, recent versions of the Healthy Eating Index (5) have been based on energy-adjusted intake. Second, we found that the averages of 2 and 3 24-h recall protein reports had substantially higher correlations with true usual intake than a single recall. This also was evident for potassium (3). Thus, the use of repeated 24-h recalls is another device that can be used to improve the quality of self-report dietary data.
Throughout their letter, Archer and Blair claim that their arguments are logical and empirically supported. In fact, their conclusions are far too sweeping.
Nutritional epidemiology has recently been criticized on several fronts, including the inability to measure diet accurately, and for its reliance on observational studies to address etiologic questions. In addition, several recent meta-analyses with serious methodologic flaws have arrived at erroneous or misleading conclusions, reigniting controversy over formerly settled debates. All of this has raised questions regarding the ability of nutritional epidemiologic studies to inform policy. These criticisms, to a large degree, stem from a misunderstanding of the methodologic issues of the field and the inappropriate use of the drug trial paradigm in nutrition research. The exposure of interest in nutritional epidemiology is human diet, which is a complex system of interacting components that cumulatively affect health. Consequently, nutritional epidemiology constantly faces a unique set of challenges and continually develops specific methodologies to address these. Misunderstanding these issues can lead to the nonconstructive and sometimes naive criticisms we see today. This article aims to clarify common misunderstandings of nutritional epidemiology, address challenges to the field, and discuss the utility of nutritional science in guiding policy by focusing on 5 broad questions commonly asked of the field.
© 2015 American Society for Nutrition.
Dietary assessment has long been known to be challenged by measurement error. A substantial amount of literature on methods for determining the effects of error on causal inference has accumulated over the past decades. These methods have unrealized potential for improving the validity of data collected for research studies and national nutritional surveillance, primarily through the NHANES. Recently, the validity of dietary data has been called into question. Arguments against using dietary data to assess diet–health relations or to inform the nutrition policy debate are subject to flaws that fall into 2 broad areas: 1) ignorance or isunderstanding of methodologic issues; and 2) faulty logic in drawing inferences. Nine specific issues are identified in these arguments, indicating insufficient grasp of themethods used for assessing diet and designing nutritional epidemiologic studies. These include a narrow operationalization of validity, failure to properly account for sources of error, and large, unsubstantiated jumps to policy implications. Recent
attacks on the inadequacy of 24-h recall–derived data from the NHANES are uninformative regarding effects on estimating risk of health outcomes and on inferences to inform the diet-related health policy debate. Despite errors, for many purposes and inmany contexts, these dietary data have proven to be useful in addressing important research and policy questions. Similarly, structured instruments, such as the food frequency questionnaire, which is the mainstay of epidemiologic literature, can provide useful data when errors are measured and considered in analyses. Adv. Nutr. 5: 447–455, 2014.
Industry sponsors' financial interests might bias the conclusions of scientific research. We examined whether financial industry funding or the disclosure of potential conflicts of interest influenced the results of published systematic reviews (SRs) conducted in the field of sugar-sweetened beverages (SSBs) and weight gain or obesity.
We conducted a search of the PubMed, Cochrane Library, and Scopus databases to identify published SRs from the inception of the databases to August 31, 2013, on the association between SSB consumption and weight gain or obesity. SR conclusions were independently classified by two researchers into two groups: those that found a positive association and those that did not. These two reviewers were blinded with respect to the stated source of funding and the disclosure of conflicts of interest. We identified 17 SRs (with 18 conclusions). In six of the SRs a financial conflict of interest with some food industry was disclosed. Among those reviews without any reported conflict of interest, 83.3% of the conclusions (10/12) were that SSB consumption could be a potential risk factor for weight gain. In contrast, the same percentage of conclusions, 83.3% (5/6), of those SRs disclosing some financial conflict of interest with the food industry were that the scientific evidence was insufficient to support a positive association between SSB consumption and weight gain or obesity. Those reviews with conflicts of interest were five times more likely to present a conclusion of no positive association than those without them (relative risk: 5.0, 95% CI: 1.3-19.3). An important limitation of this study is the impossibility of ruling out the existence of publication bias among those studies not declaring any conflict of interest. However, the best large randomized trials also support a direct association between SSB consumption and weight gain or obesity.
Financial conflicts of interest may bias conclusions from SRs on SSB consumption and weight gain or obesity. Please see later in the article for the Editors' Summary.
Background Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. Methods In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. Results A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported. Conclusions Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639 .).
BACKGROUND: Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events.
METHODS: In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years.
RESULTS: A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported.
CONCLUSIONS: Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).
Background:
The consumption of beverages that contain sugar is associated with overweight, possibly because liquid sugars do not lead to a sense of satiety, so the consumption of other foods is not reduced. However, data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain.
Methods:
We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age. Participants were randomly assigned to receive 250 ml (8 oz) per day of a sugar-free, artificially sweetened beverage (sugar-free group) or a similar sugar-containing beverage that provided 104 kcal (sugar group). Beverages were distributed through schools. At 18 months, 26% of the children had stopped consuming the beverages; the data from children who did not complete the study were imputed.
Results:
The z score for the body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group; the 95% confidence interval (CI) of the difference was -0.21 to -0.05. Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group (95% CI for the difference, -1.54 to -0.48). The skinfold-thickness measurements, waist-to-height ratio, and fat mass also increased significantly less in the sugar-free group. Adverse events were minor. When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study, the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group (P=0.06).
Conclusions:
Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children. (Funded by the Netherlands Organization for Health Research and Development and others; DRINK ClinicalTrials.gov number, NCT00893529.).
In an article that forms part of the PLoS Medicine series on Big Food, guest editors David Stuckler and Marion Nestle lay out why more examination of the food industry is necessary, and offer three competing views on how public health professionals might engage with Big Food.
Recently, some authors have questioned the validity of methods which correct relative risk estimates for measurement error and misclassification when the "gold standard" used to obtain information about the measurement error process is itself imperfect. When such an "alloyed" gold standard is used to validate the usual exposure measurement, the bias in the "regression calibration" (Rosner et al., Stat Med 1989; 8:1051-69) measurement-error correction factor for relative risks estimated from logistic regression models is derived. This quantity is a function of the correlations of the "alloyed" gold standard (X) and the usual exposure assessment method (Z) with the truth, of the ratio of the variances of X and Z, and of the correlation between the errors in the "alloyed" gold standard and the errors in the usual exposure assessment method. In this paper, it is proven that if the errors between Z and X are uncorrelated, the regression calibration method has no bias even when the gold standard is "alloyed." When a third method of exposure assessment is available and it is reasonable to assume that the errors in this method are uncorrelated with the errors in the other two exposure assessment methods, point and interval estimates of the correlation between the errors in X and Z are derived. These methods are illustrated here with data on the measurement of physical activity, vitamins A and E, and poly- and monounsaturated fat. In addition, when a third exposure assessment method is available, a modification of standard regression calibration is derived which can be used to calculate point and interval estimates of relative risk that are corrected for measurement error in both X and Z. This new method is illustrated here with data from the Health Professionals Follow-up Study, a study investigating the associations between physical activity and colon cancer incidence and between vitamin E intake and coronary heart disease. It is shown that in these examples, correlations of the errors in X and Z tended to be small. Even when moderate, estimates of relative risk corrected for error in both X and Z were not very different from the estimates which assumed that X was a true gold standard.
Objective
Financial conflicts of interest involving the food industry have been reported to bias nutrition studies. However, some have hypothesized that independently funded studies may be biased if the authors have strong a priori beliefs about the healthfulness of a food product (‘white hat bias’). The extent to which each source of bias may affect the scientific literature has not been examined. We aimed to explore this question with research involving sugar-sweetened beverages (SSB) as a test case, focusing on a period during which scientific consensus about the adverse health effects of SSB emerged from uncertainty.
Design
PubMed search of worldwide literature was used to identify articles related to SSB and health risks published between 2001 and 2013. Financial relationships and article conclusions were classified by independent groups of co-investigators. Associations were explored by Fischer’s exact tests and regression analyses, controlling for covariates.
Results
A total of 133 articles published in English met inclusion criteria. The proportion of industry-related scientific studies decreased significantly with time, from approximately 30 % at the beginning of the study period to <5 % towards the end ( P =0·003). A ‘strong’ or ‘qualified’ scientific conclusion was reached in 82 % of independent v . 7 % of industry-related SSB studies ( P <0·001). Industry-related studies were overwhelmingly more likely to reach ‘weak/null’ conclusions compared with independent studies regarding the adverse effects of SSB consumption on health (OR=57·30, 95 % CI 7·12, 461·56).
Conclusion
Industry-related research during a critical period appears biased to underestimate the adverse health effects of SSB, potentially delaying corrective public health action.
Background:
Few prospective studies have examined dairy fat in relation to cardiovascular disease (CVD).
Objective:
We aimed to evaluate the association between dairy fat and incident CVD in US adults.
Design:
We followed 43,652 men in the Health Professionals Follow-Up Study (1986-2010), 87,907 women in the Nurses' Health Study (1980-2012), and 90,675 women in the Nurses' Health Study II (1991-2011). Dairy fat and other fat intakes were assessed every 4 y with the use of validated food-frequency questionnaires.
Results:
During 5,158,337 person-years of follow-up, we documented 14,815 incident CVD cases including 8974 coronary heart disease cases (nonfatal myocardial infarction or fatal coronary disease) and 5841 stroke cases. In multivariate analyses, compared with an equivalent amount of energy from carbohydrates (excluding fruit and vegetables), dairy fat intake was not significantly related to risk of total CVD (for a 5% increase in energy from dairy fat, the RR was 1.02; 95% CI: 0.98, 1.05), coronary heart disease (RR: 1.03; 95% CI: 0.98, 1.09), or stroke (RR: 0.99; 95% CI: 0.93, 1.05) (P > 0.05 for all). In models in which we estimated the effects of exchanging different fat sources, the replacement of 5% of energy intake from dairy fat with equivalent energy intake from polyunsaturated fatty acid (PUFA) or vegetable fat was associated with 24% (RR: 0.76; 95% CI: 0.71, 0.81) and 10% (RR: 0.90; 95% CI: 0.87, 0.93) lower risk of CVD, respectively, whereas the 5% energy intake substitution of other animal fat with dairy fat was associated with 6% increased CVD risk (RR: 1.06; 95% CI: 1.02, 1.09).
Conclusions:
The replacement of animal fats, including dairy fat, with vegetable sources of fats and PUFAs may reduce risk of CVD. Whether the food matrix may modify the effect of dairy fat on health outcomes warrants further investigation.
Background:
Consumption of sugar-sweetened beverages may cause excessive weight gain. We aimed to assess the effect on weight gain of an intervention that included the provision of noncaloric beverages at home for overweight and obese adolescents.
Methods:
We randomly assigned 224 overweight and obese adolescents who regularly consumed sugar-sweetened beverages to experimental and control groups. The experimental group received a 1-year intervention designed to decrease consumption of sugar-sweetened beverages, with follow-up for an additional year without intervention. We hypothesized that the experimental group would gain weight at a slower rate than the control group.
Results:
Retention rates were 97% at 1 year and 93% at 2 years. Reported consumption of sugar-sweetened beverages was similar at baseline in the experimental and control groups (1.7 servings per day), declined to nearly 0 in the experimental group at 1 year, and remained lower in the experimental group than in the control group at 2 years. The primary outcome, the change in mean body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) at 2 years, did not differ significantly between the two groups (change in experimental group minus change in control group, -0.3; P=0.46). At 1 year, however, there were significant between-group differences for changes in BMI (-0.57, P=0.045) and weight (-1.9 kg, P=0.04). We found evidence of effect modification according to ethnic group at 1 year (P=0.04) and 2 years (P=0.01). In a prespecified analysis according to ethnic group, among Hispanic participants (27 in the experimental group and 19 in the control group), there was a significant between-group difference in the change in BMI at 1 year (-1.79, P=0.007) and 2 years (-2.35, P=0.01), but not among non-Hispanic participants (P>0.35 at years 1 and 2). The change in body fat as a percentage of total weight did not differ significantly between groups at 2 years (-0.5%, P=0.40). There were no adverse events related to study participation.
Conclusions:
Among overweight and obese adolescents, the increase in BMI was smaller in the experimental group than in the control group after a 1-year intervention designed to reduce consumption of sugar-sweetened beverages, but not at the 2-year follow-up (the prespecified primary outcome). (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT00381160.).
Forest, the pro-smoking group supported by the tobacco industry, is launching a new consumer rights campaign called Action on Consumer Choice (ACC) to encourage the alcohol and fast food industry to work with it to champion the rights of their consumers.
Forest’s director, Simon Clark, argued that drinkers of alcohol and fans of fast food would be the next targets of health campaigners if smokers’ freedoms were not respected and that some of the same tactics used against the tobacco industry were already being used against food and drink products that were deemed unhealthy.
Action on Consumer Choice, which has the slogan “Eat. Drink. Smoke. Vape. It’s your choice!” is being launched officially on 4 November 2014 at an event in London to celebrate …
The relation between sugar-sweetened beverages (SSBs) and body weight remains controversial.
We conducted a systematic review and meta-analysis to summarize the evidence in children and adults.
We searched PubMed, EMBASE, and Cochrane databases through March 2013 for prospective cohort studies and randomized controlled trials (RCTs) that evaluated the SSB-weight relation. Separate meta-analyses were conducted in children and adults and for cohorts and RCTs by using random- and fixed-effects models.
Thirty-two original articles were included in our meta-analyses: 20 in children (15 cohort studies, n = 25,745; 5 trials, n = 2772) and 12 in adults (7 cohort studies, n = 174,252; 5 trials, n = 292). In cohort studies, one daily serving increment of SSBs was associated with a 0.06 (95% CI: 0.02, 0.10) and 0.05 (95% CI: 0.03, 0.07)-unit increase in BMI in children and 0.22 kg (95% CI: 0.09, 0.34 kg) and 0.12 kg (95% CI: 0.10, 0.14 kg) weight gain in adults over 1 y in random- and fixed-effects models, respectively. RCTs in children showed reductions in BMI gain when SSBs were reduced [random- and fixed-effects: -0.17 (95% CI: -0.39, 0.05 kg) and -0.12 (95% CI: -0.22, -0.2 kg)], whereas RCTs in adults showed increases in body weight when SSBs were added (random- and fixed-effects: 0.85 kg; 95% CI: 0.50, 1.20 kg). Sensitivity analyses of RCTs in children showed more pronounced benefits in preventing weight gain in SSB substitution trials (compared with school-based educational programs) and among overweight children (compared with normal-weight children).
Our systematic review and meta-analysis of prospective cohort studies and RCTs provides evidence that SSB consumption promotes weight gain in children and adults.
Sugar-sweetened beverages (SSBs) are the single largest source of added sugar and the top source of energy intake in the U.S. diet. In this review, we evaluate whether there is sufficient scientific evidence that decreasing SSB consumption will reduce the prevalence of obesity and its related diseases. Because prospective cohort studies address dietary determinants of long-term weight gain and chronic diseases, whereas randomized clinical trials (RCTs) typically evaluate short-term effects of specific interventions on weight change, both types of evidence are critical in evaluating causality. Findings from well-powered prospective cohorts have consistently shown a significant association, established temporality and demonstrated a direct dose-response relationship between SSB consumption and long-term weight gain and risk of type 2 diabetes (T2D). A recently published meta-analysis of RCTs commissioned by the World Health Organization found that decreased intake of added sugars significantly reduced body weight (0.80 kg, 95% confidence interval [CI] 0.39-1.21; P < 0.001), whereas increased sugar intake led to a comparable weight increase (0.75 kg, 0.30-1.19; P = 0.001). A parallel meta-analysis of cohort studies also found that higher intake of SSBs among children was associated with 55% (95% CI 32-82%) higher risk of being overweight or obese compared with those with lower intake. Another meta-analysis of eight prospective cohort studies found that one to two servings per day of SSB intake was associated with a 26% (95% CI 12-41%) greater risk of developing T2D compared with occasional intake (less than one serving per month). Recently, two large RCTs with a high degree of compliance provided convincing data that reducing consumption of SSBs significantly decreases weight gain and adiposity in children and adolescents. Taken together, the evidence that decreasing SSBs will decrease the risk of obesity and related diseases such as T2D is compelling. Several additional issues warrant further discussion. First, prevention of long-term weight gain through dietary changes such as limiting consumption of SSBs is more important than short-term weight loss in reducing the prevalence of obesity in the population. This is due to the fact that once an individual becomes obese, it is difficult to lose weight and keep it off. Second, we should consider the totality of evidence rather than selective pieces of evidence (e.g. from short-term RCTs only). Finally, while recognizing that the evidence of harm on health against SSBs is strong, we should avoid the trap of waiting for absolute proof before allowing public health action to be taken.
The 2011 UN high-level meeting on non-communicable diseases (NCDs) called for multisectoral action including with the private sector and industry. However, through the sale and promotion of tobacco, alcohol, and ultra-processed food and drink (unhealthy commodities), transnational corporations are major drivers of global epidemics of NCDs. What role then should these industries have in NCD prevention and control? We emphasise the rise in sales of these unhealthy commodities in low-income and middle-income countries, and consider the common strategies that the transnational corporations use to undermine NCD prevention and control. We assess the effectiveness of self-regulation, public-private partnerships, and public regulation models of interaction with these industries and conclude that unhealthy commodity industries should have no role in the formation of national or international NCD policy. Despite the common reliance on industry self-regulation and public-private partnerships, there is no evidence of their effectiveness or safety. Public regulation and market intervention are the only evidence-based mechanisms to prevent harm caused by the unhealthy commodity industries.
The relation between dietary intake of specific types of fat, particularly trans unsaturated fat and the risk of coronary disease remains unclear. We therefore studied this relation in women enrolled in the Nurses' Health Study.
We prospectively studied 80,082 women who were 34 to 59 years of age and had no known coronary disease, stroke, cancer, hypercholesterolemia, or diabetes in 1980. Information on diet was obtained at base line and updated during follow-up by means of validated questionnaires. During 14 years of follow-up, we documented 939 cases of nonfatal myocardial infarction or death from coronary heart disease. Mutivariate analyses included age, smoking status, total energy intake, dietary cholesterol intake, percentages of energy obtained from protein and specific types of fat, and other risk factors.
Each increase of 5 percent of energy intake from saturated fat, as compared with equivalent energy intake from carbohydrates, was associated with a 17 percent increase in the risk of coronary disease (relative risk, 1.17; 95 percent confidence interval, 0.97 to 1.41; P=0.10). As compared with equivalent energy from carbohydrates, the relative risk for a 2 percent increment in energy intake from trans unsaturated fat was 1.93 (95 percent confidence interval, 1.43 to 2.61; P<0.001); that for a 5 percent increment in energy from monounsaturated fat was 0.81 (95 percent confidence interval, 0.65 to 1.00; P=0.05); and that for a 5 percent increment in energy from polyunsaturated fat was 0.62 (95 percent confidence interval, 0.46 to 0.85; P= 0.003). Total fat intake was not signficantly related to the risk of coronary disease (for a 5 percent increase in energy from fat, the relative risk was 1.02; 95 percent confidence interval, 0.97 to 1.07; P=0.55). We estimated that the replacement of 5 percent of energy from saturated fat with energy from unsaturated fats would reduce risk by 42 percent (95 percent confidence interval, 23 to 56; P<0.001) and that the replacement of 2 percent of energy from trans fat with energy from unhydrogenated, unsaturated fats would reduce risk by 53 percent (95 percent confidence interval, 34 to 67; P<.001).
Our findings suggest that replacing saturated and trans unsaturated fats with unhydrogenated monounsaturated and polyunsaturated fats is more effective in preventing coronary heart disease in women than reducing overall fat intake.
The authors examined the associations of dietary fat and specific types of fat with risk of coronary heart disease (CHD) among 78,778 US women initially free of cardiovascular disease and diabetes in 1980. They documented 1,766 incident CHD cases (including 1,241 nonfatal myocardial infarctions and 525 CHD deaths) during 20 years of follow-up. Polyunsaturated fat intake was inversely associated with CHD risk (multivariate relative risk (RR) for the highest vs. the lowest quintile = 0.75, 95% confidence interval (CI): 0.60, 0.92; p(trend) = 0.004), whereas trans-fat intake was associated with an elevated risk of CHD (RR = 1.33, 95% CI: 1.07, 1.66; p(trend) = 0.01). The associations between intakes of polyunsaturated fat and trans-fat with CHD risk were most evident among women younger than age 65 years (for polyunsaturated fat, RR = 0.66, 95% CI: 0.50, 0.85; p(trend) = 0.002 and for trans-fat, RR = 1.50, 95% CI: 1.13, 2.00; p(trend) = 0.01). The inverse association between polyunsaturated fat intake and CHD risk was strongest among women whose body mass index was >or=25 kg/m(2). Findings continue to support an inverse relation between polyunsaturated fat intake and CHD risk, particularly among younger or overweight women. In addition, trans-fat intake was associated with increased risk of CHD, particularly for younger women.
Remarks to the General Assembly meeting on the prevention and control of non-communicable disease [Internet].
- Ki-Moon B.
Alcohol and public health. Under the influence
- Gornall
Opening address at the 8th global conference on health promotion
- Chan