Challenges and Opportunities for Precision and Personalized Nutrition Proceedings of a Workshop (2022) / Chapter Skim
Currently Skimming:
4 Implementation of Precision and Personalized Nutrition
4 Implementation of Precision and Personalized Nutrition
Pages 55-76
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 55... ...
She began by disclosing that her answer to the question in her presentation's title was a skeptical "maybe." Roberto stressed that precision nutrition has tremendous potential to offer people targeted guidance based on their individual disease risks and biological responses to diet. At the same time, she asserted, while the idea of being able to provide tailored nutrition advice to individuals is appealing, doing so requires understanding the complex interplay among biological factors, food environments, and other systemslevel forces that affect health (Rodgers and Collins, 2020)
|
From page 56... ...
According to Roberto, this observation highlights the importance of applying precision nutrition in a way that does not widen income and racial/ethnic disparities. Roberto described "a vicious cycle of unhealthy dietary habits" whereby environmental drivers of food intake exploit biological, psychosocial, and social and economic vulnerabilities that contribute to overconsumption of unhealthy foods, driving preferences and demand for those foods (Roberto et al., 2015)
|
From page 57... ...
, which she proposed incorporating into the precision nutrition conversation. This framework, she explained, emphasizes the importance of developing interventions that aim to increase healthy options and/or reduce deterrents to unhealthy behaviors while also incorporating considerations related to social disadvantage and social determinants of health (Kumanyika, 2019)
|
From page 58... ...
CHALLENGES TO IMPLEMENTING PRECISION NUTRITION Peter Lurie, Center for Science in the Public Interest, prefaced his presentation by expressing excitement about the science underlying precision nutrition technologies, while cautioning that exciting science alone is not enough to improve public health. He argued that government has a role in supporting translation of the science into public health gains, but contended that current structures available to the government are inadequate to that task.
|
From page 59... ...
; inadequate adverse event reporting; lack of premarket review of performance data; unsupported manufacturer claims; inadequate product labeling because the focus is on the laboratory instead of the test; and an uneven playing field that he said results when some companies get premarket approval from the FDA and address these deficiencies while others do not. In 2020, the Secretary of Health and Human Services issued a memorandum stating that LDTs must be addressed individually in separate regulatory actions (to include Federal Register notices and comment periods)
|
From page 60... ...
REGULATORY CHALLENGES AND OPPORTUNITIES FOR PRECISION NUTRITION Robert Califf, Verily and Google Health, provided a regulatory perspective on challenges and opportunities for precision nutrition, informed by his experience as FDA's deputy commissioner for medical products and tobacco (2015–2016) and commissioner of food and drugs (2016–2017)
|
From page 61... ...
As salient characteristics of the new data environment he cited real-time access to massive amounts of data, made possible by new methods of data storage; the ubiquity and liquidity of data; little to no delay in access to data; and the ability to analyze data rapidly to gain insights and develop guidance. Califf referenced the opportunity to intervene on a person's smartphone as an example of a capability that is a product of the new data environment and offers tremendous opportunity for providing precision nutrition guidance.
|
From page 62... ...
He added that biomarker tests -- including those used for developing personalized nutrition guidance -- need to be reliable and reproducible across multiple laboratories and clinical settings, and to maintain adequate sensitivity and specificity before the data they yield can be used in subsequent evaluation steps. Otherwise, he stressed, personalized recommendations could cause harm that might not be apparent until many years later.
|
From page 63... ...
Anthony described consumer expectations in the context of the current scientific landscape. Expectations for personalized nutrition's delivery of benefit solutions are broad and inconsistent, he asserted, ranging from managing chronic disease risk, to improving digestive health or joint pain, to maintaining sustained energy and reducing stress levels.
|
From page 64... ...
With higher levels of education and socioeconomic status, he maintained, these individuals are relatively healthy and wealthy, highlighting the challenge of getting personalized nutrition solutions to populations of lower socioeconomic status. Anthony next described a model of personalized nutrition that supports creating and sustaining engagement with a wide variety of potential users (Figure 4-3)
|
From page 65... ...
Small, frequent interactions offer opportunities to provide feedback and a reason to believe that change can be achieved, he observed, adding that the type and frequency of feedback are best personalized to the user. People still want a real person behind the technology, he maintained, noting that many programs use registered dietitians in this role as they can provide nutrition expertise and serve as behavior change mediators.
|
From page 66... ...
This type of claim will subject the product to regulation as an unapproved new drug or biologic, he explained, which he said is rational but can become complicated when the objective is to classify and communicate about nutritional interventions that purport to have a beneficial effect on disease. Echoing Lurie, he went on to say that health claims and qualified health claims are about reducing the risk of developing a disease, and structure/function claims are limited to the effect of the product on the body's structure or function.
|
From page 67... ...
But, he stressed, when personalized nutrition technology reaches that point and communications about demonstrated health improvements are being developed for consumers, it will be important to have a regulatory structure that allows for communicating those benefits without unintended regulatory consequences. Hahn then provided a series of examples to support his contention that the current regulatory system is not well suited to allowing the benefits of personalized nutrition technologies to be communicated without risking allegations of misleading consumers or being regulated in a way that is inconsistent with their intended use.
|
From page 68... ...
She began by contrasting these two types of guidelines. Public health guidelines inform population-based policies and regulatory actions, such as federal nutrition programs, nutrition labeling, and population-level dietary intake assessments, she clarified, whereas individualized recommendations tailor nutrient and dietary intake, dietary patterns, and dietary intake assessment for a specific person.
|
From page 69... ...
To illustrate this point, she contrasted sodium, for which the risk of chronic disease increases as intake increases, and omega-3 fatty acids, for which the risk of chronic disease may decrease as intake increases. There could be other chronic diseases for which risk increases with intakes that are either too low or too high, she added, but in any case, the CDRR level is set to minimize chronic disease risk across the population.
|
From page 70... ...
Brannon suggested that as precision nutrition advances, consideration be given to the evidence requirements for selecting chronic disease outcomes detailed in the Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease Outcomes (NASEM, 2017) and applied by the DRI committee for sodium and potassium.
|
From page 71... ...
She identified as another opportunity for precision nutrition helping to fill the research gap of defining a "healthy population" when the prevalence of chronic disease is high. Doing so would promote better-informed public health guidelines for nutrients and dietary patterns, she argued, and enhance understanding of variance within a healthy population.
|
From page 72... ...
Incorporating Social Determinants of Health in Precision and Personalized Nutrition Models Brannon agreed with an audience member's comment that it is important to incorporate social determinants of health into precision nutrition
|
From page 73... ...
Anthony suggested that the strongest evidence from n-of-1 study designs comes from crossover studies, and Califf contended that subjective outcomes are appropriate in n-of-1 studies if a crossover design with a placebo is used. Roberto advocated for studying broad groups in any research design that is used, pointing out that if at baseline, more narrowly defined study populations are already healthier than groups not included in the study, relationships will look stronger for any positive health effects observed in response to the nutrition intervention being studied.
|
From page 74... ...
He noted that people sometimes accept degrees of imprecision because such messaging is simpler, and proposed that increased precision in nutrition guidance is not necessarily worth the potential risk of increased confusion until stronger data are available to support the associated health benefits. Califf added that food access and availability influence the degree to which people are able to follow specific dietary guidance.
|
From page 75... ...
Finally, Brannon voiced hope for the prospect of translating the effective aspects of personalized nutrition platforms into innovative solutions for implementing public health guidelines.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.