Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products

Parenteral nutrition (PN) products are regulated in the United States by the Food and Drug Administration (FDA). The FDA regulates PN products as “drugs,” and the approval of a new product depends on there being “substantial evidence” of safety and efficacy obtained from “adequate and well-controlled studies.” The processes by which the FDA approves PN products in the United States are designed to protect patients from unsafe or ineffective products, but they may also contribute to delaying and preventing access to certain valuable new products. This tutorial is designed to inform the PN community about FDA processes with regard to PN products, including the structure of FDA review teams, requirements for investigational studies, applications for marketing approval, postapproval clinical trial requirements, and requirements for studies in pediatric populations. Knowledge of how the FDA process works and how the FDA regulates PN products can help the PN community work together in advancing the development of new products.     

Association between Use of Nutrition Labels and Risk of Chronic Kidney Disease: The Korean National Health and Nutrition Examination Survey (KNHANES) 2008–2019

Nutrition labeling on food packages is increasingly found to promote healthier food choices associated with lower risk of chronic kidney disease (CKD). To examine associations between nutrition labels use and CKD risk, we conducted a nationally representative cross-sectional study of 32,080 adults from the 2008–2019 Korean National Health and Nutrition Examination Survey. Nutrition labels use was collected via self-reported questionnaires. Ascertainment and severity of CKD was determined by estimated glomerular filtration rate or proteinuria. In multivariable-adjusted (MV) logistic regression models, increasing awareness and use of nutrition labels was significantly associated with lower CKD risk (MV-adjusted OR “nutrition labels aware and use” group vs. “nutrition labels unaware” group [95% CIs]: 0.75 [0.59–0.95], P_trend:0.03). This inverse association varied with CKD’s risk of progression, with 21% and 42% reduced risk observed for CKD subtypes with “moderate” and “high” risk of progression, respectively (all P_trend ≤ 0.04). Furthermore, the nutrition labels use and CKD risk association significantly differed by age, with 35% reduced risk observed in the older group aged 49 years or older, but not in the younger group (P_interaction < 0.001). Our results suggest increasing perception and use of nutrition labels may contribute to CKD prevention and its early asymptomatic progression, especially in older adults.     

Evaluation of Food Labelling the Products with Information Regarding the Level of Sugar: A Preliminary Study

The aim of this article is to explore the reasons for seeking selected information on a food label, with particular emphasis on certain information about sugar. In order to meet the aim, in 2020, a survey was conducted among consumers aged 18–45. Predictive models (Logistic Regression) were developed for noticing “light” products and reading food labels. The results of our study indicate that consumers are mainly discouraged from reading label information by a large amount of information, the lack of time, and a general reluctance to be interested in label information. When it comes to the factors that lead people to read label information, the naturalness of the product, its organic origin, and physical activity are important. Moreover, respondents who declared that they noticed products on the market defined as “light” were those who were interested in the naturalness of the product, but also consumers declaring that they have nutritional knowledge. The results of the study indicate the need to intensify information campaigns in order to emphasize how important it is for consumers to read the information on food labels. The amount and complexity of information currently appearing on the food label may unfortunately discourage consumers from reading it, so it is important to continuously improve this form of communication with the consumer.     

Toward a Sustainability Label for Food Products: An Analysis of Experts' and Consumers' Acceptance

The recent proliferation of standards and labels for organic, fair-trade, locally produced, and healthy food products risks creating confusion among consumers. This study presents a standardized approach to developing a comprehensive sustainability label that incorporates ecological, economic, and social values. The methodology is based on an extension of modular life-cycle assessment to non-environmental sustainability criteria. Interviews with a wide range of experts (n = 65) and a consumer survey (n = 233) were conducted to analyze the feasibility and potential effectiveness of the approach. Responses indicated that a comprehensive sustainability label could considerably influence consumption patterns and facilitate cross-product comparisons.     

Soda or VitaSoda: How Product Name Influences Perceptions of Snack Food Healthfulness and the Moderating Role of Nutrition Facts Labels

ABSTRACT

Many parts of a food package label can influence consumers’ product judgments. In this study we investigate how strategic product naming influences consumers’ perceptions of snack food products’ healthfulness and nutritional content by focusing on snack food names that include (versus do not include) the noun “vita.” We also analyze how the effects of product naming are moderated by viewing the Nutrition Facts labels (NFLs). In an online experiment, participants (N = 3,049) were presented with mock packages of snack foods and given the opportunity to view the NFL. Results showed that products including “vita” in their name were perceived as more healthful than those that did not include “vita” in their name, even though their nutritional content was the same. Additionally, vita snack foods (compared to regular snack foods) were rated as significantly higher in nutrients to promote, such as fiber, vitamin D, calcium, vitamin C, and potassium and lower in nutrients to limit, such as calories, sugar, and saturated fat. Viewing the NFL appeared to mitigate the effects of product naming.     

Position of the Academy of Nutrition and Dietetics and the Society for Nutrition Education and Behavior: Food and Nutrition Programs for Community-Residing Older Adults

Given the increasing number and diversity of older adults and the transformation of health care services in the United States, it is the position of the Academy of Nutrition and Dietetics and the Society for Nutrition Education and Behavior that all older adults should have access to evidence-based food and nutrition programs that ensure the availability of safe and adequate food to promote optimal nutrition, health, functionality, and quality of life. Registered dietitian nutritionists and nutrition and dietetics technicians, registered, in partnership with other practitioners and nutrition educators, should be actively involved in programs that provide coordinated services between the community and health care systems that include regular monitoring and evaluation of programming outcomes. The rapidly growing older population, increased demand for integrated continuous support systems, and rising cost of health care underscore the need for these programs. Programs must include food assistance and meal programs, nutritional screening and assessment, nutrition education, medical nutrition therapy, monitoring, evaluation, and documentation of evidence-based outcomes. Coordination with long-term care services and support systems is necessary to allow older adults to remain in their homes; improve or maintain their health and manage chronic disease; better navigate transitions of care; and reduce avoidable hospital, acute, or long-term care facility admissions. Funding of these programs requires evidence of their effectiveness, especially regarding health, functionality, and health care–related outcomes of interest to individuals, caregivers, payers, and policy makers. Targeting of food and nutrition programs involves addressing unmet needs for services, particularly among those at high risk for poor nutrition. Registered dietitian nutritionists and nutrition and dietetics technicians, registered must increase programmatic efforts to measure outcomes to evaluate community-based food and nutrition services.Position StatementIt is the position of the Academy of Nutrition and Dietetics and the Society for Nutrition Education and Behavior that older adults should have access to evidence-based food and nutrition programs that ensure the availability of safe and adequate food to promote optimal nutrition, health, functionality, and quality of life. Registered dietitian nutritionists and nutrition and dietetics technicians, registered, in partnership with other practitioners and nutrition educators, should be actively involved in programs that provide coordinated services between the community and health care systems that include regular monitoring and evaluation of programming outcomes. The rapidly growing older population, increased demand for integrated continuous support systems, and rising cost of health care underscore the need for these programs.     

Psycho-Behavioural Segmentation in Food and Nutrition: A Systematic Scoping Review of the Literature

Inadequate dietary intakes are a key modifiable risk factor to reduce the risk of developing non-communicable diseases. To encourage healthy eating and behaviour change, innovative public health interventions are required. Social marketing, in particular segmentation, can be used to understand and target specific population groups. However, segmentation often uses demographic factors, ignoring the reasons behind why people behave the way they do. This review aims to explore the food and nutrition related research that has utilised psycho-behavioural segmentation. Six databases from were searched in June 2020. Inclusion criteria were: published 2010 onwards, segmentation by psycho-behavioural variables, outcome related to food or nutrition, and healthy adult population over 18 years. 30 studies were included; most were quantitative (n = 28) and all studies used post-hoc segmentation methods, with the tools used to segment the population varying. None of the segments generated were targeted in future research. Psycho-behavioural factors are key in understanding people’s behaviour. However, when used in post-hoc segmentation, do not allow for effective targeting as there is no prior understanding of behaviours that need to change within each segment. In future, we should move towards hybrid segmentation to assist with the design of interventions that target behaviours such as healthy eating.     

A Meta-Epidemiological Study of Positive Results in Clinical Nutrition Research: The Good,the Bad and the Ugly of Statistically Significant Findings

Positive (statistically significant) findings are easily produced in nutrition research when specific aspects of the research design and analysis are not accounted for. To address this issue, recently, a pledge was made to reform nutrition research and improve scientific trust on the science, encompass research transparency and achieve reproducibility. The aim of the present meta-epidemiological study was to evaluate the statistical significance status of research items published in three academic journals, all with a focus on clinical nutrition science and assessing certain methodological/transparency issues. All research items were published between the years 2015 and 2019. Study design, primary and secondary findings, sample size and age group, funding sources, positivist findings, the existence of a published research protocol and the adjustment of nutrients/dietary indexes to the energy intake (EI) of participants, were extracted for each study. Out of 2127 studies in total, those with positive findings consisted of the majority, in all three journals. Most studies had a published research protocol, however, this was mainly due to the randomized controlled trials and not to the evidence-synthesis studies. No differences were found in the distribution of positive findings according to the existence/inexistence of a published research protocol. In the pooled sample of studies, positive findings differed according to study design and more significant findings were reported by researchers failing to report any funding source. The majority of items published in the three journals (65.9%) failed to account for the EI of participants. The present results indicate that there is still room for the improvement of nutrition research in terms of design, analyses and reporting.     

Food and Nutrition Care in Long-Term Care Facilities: Examining the Perspectives of Frontline Workers

Abstract

Malnutrition in older adults residing in long-term care facilities continues to be a problem in the United States. Existing research has identified a list of possible contributing factors, including staffing problems. Few studies on food and nutrition care have attempted to gain the perspectives of nursing or dietary aides (henceforth, aides), the frontline staff who work most closely with the residents of long-term care facilities. The current study takes a qualitative approach grounded in a theoretical perspective based on Total Quality Management (TQM) to increase understanding of the interpersonal and management practices that affect resident wellbeing, health, and nutrition. Four focus groups (n?=?24) were conducted with aides working in long-term care facilities. Aides expressed emotional closeness with residents and provided detailed knowledge about food and nutrition care. They reported both compassion fatigue and satisfaction. An element of dissatisfaction related to aide relationships with management and other employees who did not actively solicit their perspectives and knowledge on resident feeding. The knowledge and experience of aides could be better utilized by shifting management strategies to focus on employee empowerment and training. Principles of TQM could be applied to improve food and nutrition care in long-term care facilities.     

The Changing Face of Food and Nutrition in Canada and the United States: Opportunities and Challenges for Older Adults

ABSTRACT

Science and technology are modernizing the field of nutrition and are consequently increasing its complexity. New food developments such as fortified foods and functional foods are evidence of its modernization. The increased specificity of nutrient- and food-intake recommendations and the breadth of claims on food packages are evidence of nutrition's growing complexity. Unfortunately, research on the consumer acceptability of new food developments and nutrition education initiatives has not kept pace with advancements in the field. This is especially true for older adults, a subgroup of the population that appears to be under-researched and not commonly targeted with education initiatives. Older adults are the fastest growing segment of the North American population. Research and education aimed at this demographic is warranted to ensure older adults have the right knowledge and skill set to optimize their food selections and dietary patterns with the possibility of improving health and the quality and longevity of life.     

What Works to Improve Nutrition and Food Sustainability across the First 2000 Days of Life: A Rapid Review

Informed by the Innocenti framework, this rapid review of systematic reviews (n = 60) and sentinel grey literature (n = 27) synthesises the evidence of what works to improve nutrition and food sustainability across the first 2000 days. Most systematic reviews focused on interventions targeting the behaviour of parents and caregivers (n = 49), with fewer reviews focusing on the personal (n = 7) and external (n = 4) food environments. No reviews focused on food supply-chain activities. Most reviews were rated as critically low (n = 28, 47%) or low (n = 21, 35%) quality using AMSTAR 2. Evidence supports the effectiveness of multi-component breastfeeding interventions, interventions delivered in home and child-care settings, particularly when involving parents, interactive skill building and repeated exposure to vegetables. Food vouchers and access to local farmers markets and community gardens have potential for improving access and availability to healthier foods, while evidence supports interventions improving the external food environment, including fiscal strategies such as the SSB tax, restrictions on marketing and advertising of discretionary products and improved food labelling. Overall, this review highlights the importance of action across a range of settings and sectors at the international, national and local levels to improve young children’s diets.     

Medical Nutrition Therapy Is Effective in the Management of Hypoglycemia Caused by Insulin Antibodies: A Case Report and Literature Review

Autoimmune antibodies, induced by exogenous insulin preparations, may result in labile glucose control and frequent hypoglycemia in some rare cases. In addition to insulin cessation, immune suppressants and/or plasmapheresis have been used as the primary remedies for these patients. Some previous studies also indicate that the condition tends to remit spontaneously after discontinuation of insulin exposure. Because of this, the clinical importance of nutritional interventions and behavioral approaches, which may play a role in ameliorating the symptoms, should also be emphasized. Herein, we report on a 64-year-old man with hypoglycemia induced by insulin antibodies (IAs), whose hypoglycemic symptoms significantly improved after the implementation of nutrition therapy. This rare case expands our knowledge of the management of hypoglycemia, and for the first time highlights the significance of nutritional and lifestyle intervention in treatment of IA-induced hypoglycemia.

 

Key teaching points:

• ? Exogenous insulin administration may induce autoimmune antibodies to insulin, leading to frequent hypoglycemia.

• ? We report a case with frequent hypoglycemia caused by IAs after exogeneous insulin exposure.

• ? The patient's symptoms were alleviated by nutrition therapy.

• ? We demonstrate for the first time the significance of dietary and behavioral interventions in management of IA-induced hypoglycemia.