CONSUMER UNDERSTANDING AND USE OF HEALTH INFORMATION ON PRODUCT LABELS: MARKETING IMPLICATIONS FOR FUNCTIONAL FOOD

In recent years, the numbers of functional foods being developed and subjected to scientific evaluation have increased substantially. The main characteristic of functional foods that distinguishes them from conventional foods is the potential health benefit, which can be considered to be a credence attribute of product quality. Because this characteristic cannot be easily assessed even after consumption, an asymmetric information environment for health benefits has emerged where producers have more information than consumers. Thus the government intervenes by regulating the provision of health information on product labels in order to avoid potential market failures. The Food and Drug Administration (FDA) recently amended the way health claims on labels of conventional food and dietary supplements are managed. The new policy on qualified health claims allows claims to be made based on different levels of supporting scientific evidence. The policy goal is to encourage firms to make accurate, science-based claims about the health benefits of their products while helping consumers prevent disease and improve their health through sound dietary decisions using nutrition information. This marks a break from the previous environment where a lengthy approval process was argued to provide a road block for food firms wanting to market functional foods based on emerging evidence of diet to health links. This study has two objectives. First, to determine how consumers use health and nutrition information on food labels to form judgments about product quality, using the Elaboration Likelihood Model (ELM) as a theoretical framework. Second, to examine whether consumers can differentiate various levels of health claims, specifically the new qualified language, approved by FDA in 2003. It is interesting to determine whether consumers understand the different levels of scientific evidence supporting such claims and whether they can distinguish between the disclaimer languages used. Understanding how consumers use health and nutrition information on product labels has implications for both public policy and food manufacturers who use health claims as tools to market their products e.g., functional foods. This study used a still hypothetical functional food product a wheat cracker containing soy protein. It has been shown that soluble fiber and isoflavones, which can be found in wheat and soy products, respectively, independently help prevent the risk of several maladies including cancer and heart disease. A 5 (claim information on the front label a control condition and the four levels of qualified health claim) x 2 (information on Nutrition Facts) between-subjects factorial design was applied. Five versions of claim information were manipulated, including a control condition and four levels of qualified health claim. Each claim contained explicit relationships between nutrients and diseases i.e., isoflavones - heart disease and soluble fiber - cancers, but had different disclaimers explaining the level of scientific evidence supporting the claim. A report card was also included to inform consumers about the various claim levels, ranging from level A to D. Information on the Nutrition Facts panel was manipulated representing a "healthy" and an "unhealthy" version. Three hundred and seventy-two undergraduate students participated in the study, receiving extra credit for a Marketing class. Several multi-item scales are used as dependent variables, including attitude toward the product, buying intention, strength of evaluation about scientific studies to support claim, confidence about claim statement, perception of product's health benefit, and information search. A univariate analysis of variance (ANOVA) is conducted to test main and interaction effects among independent variables on a dependent variable. The results of this study suggest that consumers pay attention to information from all sources including the front label and Nutrition Facts panel. Even though it is shown that consumers react more positively to versions with health claims, there is no evidence to support the first hypothesis that consumers are more careful in evaluating product quality when health and nutrition information is present on the front package. Nevertheless, consumers are able to differentiate healthy products from unhealthy products, regardless of the presence of health and nutrition information on the front label. This study examines whether consumers understand and can distinguish various levels of qualified health claims. Although evidence suggests that consumers react differently to various claim levels, it is not clear whether people understand differences in the scientific support of these claims, as described in the disclaimer. Despite an increasing trend in attitude and purchase intention from the weakest claim (level D) to the strongest claim (level A), there is no statistically significant difference among claim levels when using measures of evaluation of strength of scientific studies, confidence about claim information, and perception of product's health benefit. From the public policy perspective, the results of this study can help determine how consumers evaluate health and nutrition information. It is shown that consumers do not overlook information from other parts of the label specifically the Nutrition Facts panel and that the presence of health and nutrition information on the front label is not likely to mislead consumers. The key issue here that needs further investigation is how to effectively provide information on the front label to consumers. FDA's goal is to permit the use of more, better, easily understood, and up-to-date scientific information about how dietary choices can affect consumers' health on food labels. It is important to identify optimal levels of qualified health claims, perhaps only two levels instead of four levels, so that consumers can distinguish and understand differences in terms of the scientific support for the claims and product benefits. As for the food industry, the results of this study can help food manufacturers decide what level of health and nutrition information they should provide to consumers. In addition to understanding the petitioning procedures for different claims, food firms must determine which, how, and when consumers understand and use health information in order to find the most efficient marketing communication channels.Health Economics and Policy,

Characterization of the Mechanism of Tolerance to Terbacil for a Selected Line of Alfalfa

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Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design

PARP inhibitor; Androgen receptor; EnzalutamideInhibidor de PARP; Receptor d'andrògens; EnzalutamidaInhibidor de PARP; Receptor de andrógenos; EnzalutamidaPARP inhibitors in combination with androgen receptor-targeted therapy have demonstrated potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Here, we describe the design and rationale of the multinational, phase III, two-part TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide as a first-line treatment for patients with mCRPC with or without DNA damage response (DDR) alterations. This study has two co-primary end points: radiographic progression-free survival (rPFS) by blinded independent clinical review in all-comers (cohort 1) and in patients with DDR alterations (cohort 2). TALAPRO-2 will demonstrate whether talazoparib plus enzalutamide can significantly improve the efficacy of enzalutamide in terms of rPFS in both molecularly unselected and DDR-deficient patients with mCRPC (NCT03395197)

Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer

Clinical trial; Enzalutamide; TalazoparibEnsayo clínico; Enzalutamida; TalazoparibAssaig clínic; Enzalutamida; TalazoparibWhat is this summary about? This summary describes the design of an ongoing research study (also known as a clinical trial) called TALAPRO-2. The TALAPRO-2 trial is testing the combination of two medicines called talazoparib and enzalutamide as a first treatment in adult men with metastatic castration-resistant prostate cancer. The study began in December 2017 and has enrolled 1037 adult men with metastatic castration-resistant prostate cancer from 26 countries. What is metastatic castration-resistant prostate cancer? Metastatic castration-resistant prostate cancer is a type of cancer that has advanced beyond the prostate and continues to grow even when testosterone levels in the blood are suppressed. Which medicines are being tested? The combination of talazoparib plus enzalutamide will be compared with enzalutamide plus placebo. Enzalutamide is approved to treat men with prostate cancer. Talazoparib is not approved to treat men with prostate cancer. A placebo does not contain any active ingredients and is also known as a sugar pill. What are the aims of the TALAPRO-2 trial? The TALAPRO-2 trial will find out if combining talazoparib with enzalutamide increases the length of time the men in the study live without their cancer getting worse compared with enzalutamide plus placebo. The study will also measure how long men in the study live and any side effects the men have while they are taking the study medicines. Researchers are also testing the DNA from the tumor cells of all men in the study to find out if they have faulty DNA repair genes. Clinical Trial Registration: NCT0339519 (ClinicalTrials.gov

The Effect of Race and Chronic Obstructive Pulmonary Disease on Long-Term Survival after Coronary Artery Bypass Grafting

Background: Chronic obstructive pulmonary disease (COPD) is a known predictor of decreased long-term survival after coronary artery bypass grafting (CABG). Differences in survival by race have not been examined. Methods: A retrospective cohort study was conducted of CABG patients between 2002 and 2011. Long-term survival was compared in patients with and without COPD and stratified by race. Hazard ratios (HR) and 95% confidence intervals (CI) were computed using a Cox regression model. Results: A total of 984 (20%) patients had COPD (black n = 182; white n = 802) at the time of CABG (N = 4,801). The median follow-up for study participants was 4.4 years. COPD was observed to be a statistically significant predictor of decreased survival independent of race following CABG (no COPD: HR = 1.0; white COPD: adjusted HR = 1.9, 95% CI = 1.7–2.3; black COPD: adjusted HR = 1.6, 95% CI = 1.1–2.2). Conclusion: Contrary to the expected increased risk of mortality among black COPD patients in the general population, a similar survival disadvantage was not observed in our CABG population

Adverse prognostic and predictive significance of low DNA-dependent protein kinase catalytic subunit (DNA-PKcs) expression in early-stage breast cancers

Background: DNA-dependent protein kinase catalytic subunit (DNA-PKcs), a serine threonine kinase belonging to the PIKK family (phosphoinositide 3-kinase-like-family of protein kinase), is a critical component of the non-homologous end joining (NHEJ) pathway required for the repair of DNA double strand breaks. DNA-PKcs may be involved in breast cancer pathogenesis. Methods: We evaluated clinicopathological significance of DNA-PKcs protein expression in 1161 tumours and DNA-PKcs mRNA expression in 1950 tumours. We correlated DNA-PKcs to other markers of aggressive phenotypes, DNA repair, apoptosis and cell cycle regulation. Results: Low DNA-PKcs protein expression was associated with higher tumour grade, higher mitotic index, tumour de-differentiation and tumour type (ps<0.05). Absence of BRCA1, low XRCC1/SMUG1/APE1/Polβ were also more likely in low DNA-PKcs expressing tumours (ps<0.05). Low DNA-PKcs protein expression was significantly associated with worse breast cancer specific survival (BCCS) in univariate and multivariate analysis (ps<0.01). At the mRNA level, low DNA-PKcs was associated with PAM50.Her2 and PAM50.LumA molecular phenotypes (ps<0.01) and poor BCSS. In patients with ER positive tumours who received endocrine therapy, low DNA-PKcs (protein and mRNA) was associated with poor survival. In ER negative patients, low DNA-PKcs mRNA remains significantly associated with adverse outcome. Conclusions: Our study suggests that low DNA-PKcs expression may have prognostic and predictive significance in breast cancers

Dysfunction of the Intestinal Microbiome in Inflammatory Bowel Disease and Treatment

Background: The inflammatory bowel diseases (IBD) Crohn's disease and ulcerative colitis result from alterations in intestinal microbes and the immune system. However, the precise dysfunctions of microbial metabolism in the gastrointestinal microbiome during IBD remain unclear. We analyzed the microbiota of intestinal biopsies and stool samples from 231 IBD and healthy subjects by 16S gene pyrosequencing and followed up a subset using shotgun metagenomics. Gene and pathway composition were assessed, based on 16S data from phylogenetically-related reference genomes, and associated using sparse multivariate linear modeling with medications, environmental factors, and IBD status. Results: Firmicutes and Enterobacteriaceae abundances were associated with disease status as expected, but also with treatment and subject characteristics. Microbial function, though, was more consistently perturbed than composition, with 12% of analyzed pathways changed compared with 2% of genera. We identified major shifts in oxidative stress pathways, as well as decreased carbohydrate metabolism and amino acid biosynthesis in favor of nutrient transport and uptake. The microbiome of ileal Crohn's disease was notable for increases in virulence and secretion pathways. Conclusions: This inferred functional metagenomic information provides the first insights into community-wide microbial processes and pathways that underpin IBD pathogenesis