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Reconciliation of Differences between Observational Studies and Randomized Controlled Trials: A Case Study on Low Calorie Sweeteners

Scientific evidence is commonly categorized into levels based on quality of evidence, commonly referred to as the hierarchy of evidence. The complexity of evaluating study quality based on study design becomes problematic for dietary exposures and health outcomes with conflicting evidence observed in observational studies and RCTs. Such conflicting evidence is well documented for low calorie sweeteners (LCS), in which observational trials tend to identify adverse associations between LCS use and adiposity, type 2 diabetes (T2D), mortality, cardiovascular disease (CVD), and cancer while RCTs highlight benefits or no effect of LCS on body weight, energy intake, markers of T2D, and markers of CVD (6). One possible explanation for this is that observational trials and RCT are simply addressing different research questions, evaluating different exposures, comparators, and outcomes.

 

The objective of the proposed project is to educate stakeholders on how to interpret contrasting evidence from observational studies and RCTs based on methodological differences between study designs, using LCS as a case-study. A rapid review of systematic reviews and metaanalyses on LCS and various health outcomes will be conducted to highlight how different intervention/exposures, comparators, outcomes, and study designs produce varying conclusions regarding the efficacy and safety of LCS. The deliverables of this project will be a peer-reviewed publication and presentation of findings at a conference for nutrition and dietetics practitioners

Institution: USDA Agricultural Research Service

Principal Investigator: Kelly Higgins, MPH PhD; David Baer, PhD

Amount: $2K (Matthew Kramer, USDA ARS - retired); other costs covered by USDA’s congressional appropriation

Year: 2022

This work was supported by the IAFNS Low- and No-Calorie Sweeteners Committee.

Understanding Authoritative Decisions Around Selection and Validation of Cognitive Performance Measures – with a Focus on Nutrition-Related Research

The objective of this project is to document the outcomes of an expert roundtable with the goal to understand decisions and approaches that underlie cognitive assessment tool selection by authoritative groups. This effort aims to enable the advancement of evidence evaluation and evidence development to support future dietary guidance, and to document learnings and how they can be used to support future DGAC evidence reviews related to diet/nutrition and cognitive health.

Principal Investigator: Amy R. Romijn, PhD, Swansea University

Amount: $5,000

Year: 2022

View this project on the Center for Open Science’s Open Science Framework here. 

View this project on the PROSPERO website here.

This work was supported by the IAFNS Cognitive Health Committee.

Framework for Defining Suitable Recycled Resin Based on Intended End-Use and Characterizing Potential Chemicals of Concern

Changes in consumer behavior and growth in convenience foods, cosmetics, and pharmaceutical products complicates the use of recycled materials by requiring sophisticated and complex multilayer packaging solutions and increasing the amount of packaging waste. Many packaging materials, such as multilayer flexible and rigid plastics, are primarily sent to landfills. This project will develop a common standard that defines grades of PCR plastics with necessary performance properties and regulatory compliance for various uses including food contact applications. This proposal will increase the value of food and non-food grade plastics through identifying standards and grades of recycled plastics by end use. It will also provide a much-needed understanding of performance properties and regulatory compliance of post-consumer plastic markets

Institution: Iowa State University

Principal Investigator: Greg Curtzwiler

Amount: $55,295

Year: 2022

This work was supported by the IAFNS Food Packaging Safety & Sustainability Committee.

Development of a Human Whole-Stool Reference Material – NIST Collaboration

Over the past 10+ years, it has become evident that the human gut microbiome plays a critical role in a vast and disparate set of health and disease states; including diabetes, obesity, cancer and depression. To identify new biomarkers that may serve as disease indicators and to understand biologically‐relevant properties of the human gut microbiome, validated measurements that accurately describe various properties of the microbial community, both quantitatively and qualitatively, are needed. The aim of this project is to develop a set of Human Whole Stool Reference Materials that are certified by the National Institute for Standards and Technology (NIST) for clinically-relevant metabolites. The set will be derived from a small cohort of donors who are selected based on their health or disease state (e.g. obesity vs. healthy, diet controlled, etc.). IAFNS is collaborating with NIST to develop a list of metabolites with likely relevance for health, that would be useful to include/measure in the material.

Institutions: The National Institute for Standards and Technology, BioIVT

Principal Investigator: The National Institute for Standards and Technology

Amount: $73,450

Year: 2022

Read more: Workshop Report: Toward The Development Of A Human Whole Stool Reference Material For Metabolomic And Metagenomic Gut Microbiome Measurements

This work was supported by the IAFNS Gut Microbiome Committee.

Moving Forward After Over 40 Years Of Guidance: Innovation And Partnerships To Reduce Sodium Intake

Recorded August 9, 2022

IAFNS is a Continuing Professional Education (CPE) provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 1.0 Continuing Professional Education Unit (CPEU) for completion of this recorded webinar until August 8, 2025.

Description: Sodium is ubiquitous in the food supply and plays multiple important functional roles in food beyond taste, including preservation, safety, shelf life, dough performance, texture and flavor enhancer. The specific combination of roles and levels needed to achieve e.g., safety differ for various foods. Sodium reduction is therefore not a one-size-fits-all-foods approach; new tools, along with technical innovation and food science expertise, will be required to help the food industry achieve the targets for sodium reduction issued in October 2021 by the US Food and Drug Administration (FDA), while producing products that are satisfactory to consumers. Success will require dedication and partnership across suppliers, the food industry, and regulatory and public health agencies. In this session, an update on FDA efforts to support sodium reduction in foods will be provided. An overview of why and how sodium is used in foods, tools for its reduction, and possible ways to maximize the value of sodium-contributing foods will be covered. Finally, the need for cross-sector partnerships and innovation to achieve new goals will be discussed.

Webinar program:

Naomi Fukagawa, MD PhD, USDA ARS – Moderator
Robin Mckinnon, PhD, MPA, US Food and Drug Administration
Mavra Ahmed, PhD, University of Toronto
Christine Nowakowski, PhD, General Mills

Commission on Dietetic Registration Performance Indicators:

  • 4.1.2 Interprets and integrates evidence-based research and literature in decision-making
  • 6.2.3. Analyzes and interprets data to form valid conclusions and to make recommendations
  • 8.2.1 Engages in educational activities to maintain knowledge and to obtain new knowledge of diseases and clinical conditions

If a CEU certificate is needed, please complete the survey

Translation of Consumer-Articulated Cognitive Benefits to Validated Research Tools

The degree to which the outcomes measured by cognitive performance tests are aligned with outcomes of interest to consumers has not been documented. Consumer needs are expressed through specific terms that are meaningful to them. For example, terms commonly used by consumers in the cognitive health space are mood, focus, sharpness, and mental clarity, among others. However, some individuals may view “focus” as spending 20 straight minutes on a task, while others may view “focus” as entering a state of deeper thinking on a problem. Validated cognitive performance research tools may or may not actually be documenting cognitive benefits as understood by consumers, and/or there may be different cognitive tests that evaluate various types of focus. Understanding what research tools are able to demonstrate, and alignment with consumer understanding is critical to the development of products and dietary recommendations that support realizable cognitive benefits.

Institution: National Opinion Research Center (NORC), at the University of Chicago

Principal Investigator: Alyssa Ghirardelli, MPH, RD and Laura Wagstaff, MPH

Amount: $43,000

Year: 2022

View this project on the Center for Open Science’s Open Science Framework here. 

This work was supported by the IAFNS Cognitive Health Committee.

“Crash Course” On Design And Interpretation Of Gut Microbiome Research

Recorded July 21, 2022

The Academy of Nutrition and Dietetics is an accredited CPE provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 1.0 CPEU for completion of this recorded webinar until May 31, 2024.

Description: Dietitians and other practitioners will be working in the evolving field of gut microbiome science for decades to come. Understanding the fundamentals of research design and interpretation are likely to be core skills. Once research is generated, interpretation and application of findings requires an appreciation for dynamics that extend beyond the food, nutrient, or intervention of interest. Effective application of gut microbiome research requires clinicians to critically appraise methodological elements of research when interpreting results. In this webinar, an overview of best practices for designing and conducting diet-microbiome research in humans will be provided. Topics will include not only intervention study designs but also recruitment tips, sampling methods, important metadata to collect, and more. Attendees will likewise understand important elements to consider when interpreting and applying gut microbiome research.

Webinar program:

Moderator: Mary Lesser, PhD, RD, University of California, Berkeley
Speaker: Sarah Comstock, PhD, Michigan State University
Speaker: Levi Teigen, PhD, RD, University of Minnesota

Q&A and discussion

 

Commission on Dietetic Registration Performance Indicators:

  • 4.1.2 Interprets and integrates evidence-based research and literature in decision-making.
  • 6.2.2 Selects and uses appropriate tools and skills to collect and interpret research data.
  • 8.1.1 Interprets and applies evidence-based literature and standards for determining nutritional needs of target audiences.

If a CEU certificate is needed, please complete the survey

What Is “Sweetness”? The Biological Drive For Sweet Taste And Role In Quality Of Life For Individuals With T1DM

Recorded July 19, 2022

IAFNS is a Continuing Professional Education (CPE) provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 1.0 Continuing Professional Education Unit (CPEU) for completion of this recorded webinar until July 19, 2025.

Description: Several authorities recommend reduction or avoidance of intake of e.g., “sweet flavors”, and suggest that intake of sweet taste in the diet promotes the desire for more sweet, resulting in greater energy intakes. However, the effect of limiting sweet taste on reduction of sugars or energy intake is unknown. In addition, the role of sweetness in the context of sensory perception and the total diet is complex, and the ability to change preference for sweet remains under investigation. Given the biological drive for sweet taste, low- and no- calorie sweeteners (LNCSs) have been acknowledged as a tool for reducing the intake of total carbohydrates, and particularly added sugars, in the nutritional management of diabetes. Although water is the standard of care for individuals with diabetes, LNCSs may help to improve Quality of Life (QoL) when some sweet taste is desired. Reduced QoL can negatively affect diabetes-related outcomes. In this session, the biology of sweet taste and its role in the total diet will be reviewed. In addition, new data from a study assessing the relationship between LNCS use and QoL in adults with Type I Diabetes will be presented.

 

Webinar program:

Ann Coulston, MS RD FADA, Stanford University Medical Center (Retired) – Moderator

Nancy Rawson, PhD MS, Monell Chemical Senses Center

Halis Akturk, MD, Barbara Davis Center for Diabetes

Q&A and discussion

Commission on Dietetic Registration Performance Indicators:

  • 4.1.2 Interprets and integrates evidence-based research and literature in decision-making.
  • 6.2.5 Applies research/evidence-based findings to improve practice, service delivery, and health of customers.
  • 8.1.2 Applies knowledge of food and nutrition as well as the biological, physical, and social sciences in practice.

If a CEU certificate is needed, please complete the survey

Comparison of Food Category Contributors to Sodium Intake from Stores vs. Restaurants

The FDA released the final voluntary sodium reduction guidance in 2021. The targets presented are applicable to both consumer packaged goods and prepared/restaurant foods. Research indicates that the sodium contribution of restaurant foods is greater than that of foods consumed at home, including processed foods. There is an opportunity to understand these contributions, in totality and at the food category level, using updated data – to better target sodium reduction efforts. Distinguishing the contribution of foods from at home (including processed foods from a grocery store) compared to away-from-home consumption is important, as emphasis on e.g., the restaurant sector may have the greatest impact on intake. In addition, understanding the specific food category contributors from each source may indicate that emphasis on specific foods differs for foods consumed at home compared to away-from-home. This could inform food development, recipe formulation, and dietary guidance. The SoFHI committee is supporting an analysis of NHANES 2017-2018 to test the hypothesis that the types of foods obtained from restaurants are associated with higher levels of sodium intake compared to the types of foods obtained from stores.

Institution: Food & Nutrition Database Research, Inc.
Principal Investigator: Debra R. Keast, PhD
Amount: $47,500
Year Awarded: 2022

This work is supported by IAFNS Sodium Committee.

View this project on the Center for Open Science's Open Science Framework.

IAFNS ACNC: Maternal and Child Diet & Physical Activity

Recorded May 26, 2022

IAFNS is a Continuing Professional Education (CPE) provider with the Commission on Dietetic Registration (CDR). CDR Credentialed Practitioners will receive 1.0 Continuing Professional Education Units (CPEUs) for completion of this recorded webinar until May 26, 2025.

Description: The session will present the work of Drs. Aline Andres and Taren Swindle, affiliated faculty members at the Arkansas Children’s Nutrition Center, exploring life course determinants of health during several critical periods, including preconception, pregnancy and early childhood. Progress in our understanding of maternal programming of offspring metabolism will be summarized, followed by a review of interventions that may mitigate such effects. In addition, maternal determinants of human milk composition that affect child’s growth and body composition will be explored. After a brief presentation of an implementation science framework, the session will focus on the results of an early childcare intervention intended to improve intake of fruits and vegetables in children aged 3 to 5 y. In closing, a review of other implementation projects aiming at improving physical activity in pregnant women and preschoolers will be provided.

Webinar program:

Prenatal and postnatal programming of health - Dr. Aline Andreas, University of Arkansas ACNC

Implementation Science to improve diet and physical activity in early life - Dr. Taren Swindle, University of Arkansas ACNC

Commission on Dietetic Registration Performance Indicators:

  • 6.2.3 Analyzes and interprets data to form valid conclusions and to make recommendations.
  • 6.4.2 Demonstrates serious inquiry, examination, and experimentation aimed at the discovery and interpretation of knowledge, or the revision of guidelines, theories, policies or laws.
  • 8.1.2 Integrates knowledge of biological, physical, and social sciences with knowledge of food and nutrition to make decisions related to nutrition care.

If a CEU certificate is needed, please complete the survey