Examining Special Nutritional Requirements in Disease States Proceedings of a Workshop (2018) / Chapter Skim
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6 Exploring Potential Opportunities
6 Exploring Potential Opportunities
Pages 101-112
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From page 101... ...
One theme that repeatedly emerged was the importance of understanding the difference between approaches for treating, curing, or preventing disease, and approaches for managing a disease so that the person's health improves by compensating for what the disease is doing to nutrient metabolism. Sometimes a drug is involved with managing disease, but sometimes the management issues are related to different nutrient requirements.
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From page 102... ...
Timothy Morck, Founder and President of S pectrum Nutrition LLC, provided an industry perspective, and Virginia Stallings, Children's Hospital of Philadelphia, reflected on the workshop from her experience and perspective as a clinician. PANEL DISCUSSION Susan Barr Barr posed the following key questions that the workshop presentations raised in relation to DRIs: • Dietary requirements for what?
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From page 103... ...
Are we looking for the requirement based on the same indicator of adequacy as was used in the apparently healthy population? Or would it be a dif ferent indicator of adequacy that is somehow adversely affected by the disease?
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From page 104... ...
• The current evidence base is extremely limited. A systematic review that is done to support a guideline must be done in a way that facil itates decision making and should use a best-evidence approach, which could potentially include using evidence from case series and case reports.
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From page 105... ...
• A clear scientific process that is able to establish distinctive nutri tional requirements in a disease state will promote the rapid devel opment of an appropriate regulatory framework to guide industry in developing safe and efficacious products that benefit patients. Faster progress in identifying and validating appropriate nutri tional biomarkers is imperative.
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From page 106... ...
Clinicians have the responsibility to keep moving the field forward and include the new thinking about study design, data collection, and evidence standards in clinical care. • Until recently, the Dietary Guidelines for Americans and the DRI process have remained relatively silent on chronic disease issues.
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From page 107... ...
The panelists reflected on a question about what constitutes proof for a distinctive nutritional requirement, given the need by patients, clinicians, and industry to have a regulatory framework for nutritional therapy. Com panies can create any medical foods, but clinicians need evidence of effectiveness for nutrients or other bioactive compounds.
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From page 108... ...
Inborn errors of metabolism, in all of their complexity, are a harbinger of what is in the future as principles of nutritional management are translated from specific disease states to broader chronic disease indications. Finally, innovations in identifying people at risk, developing strategies for assessing the impact of interventions, and analyzing data are all needed to be able to make recommendations in the context of increasing disease rates in populations.
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From page 109... ...
She highlighted other specific questions, such as what kind of study designs and scientific data would guide FDA in defining a more streamlined regulatory approval and affect reimbursement decisions and what research studies the Foundation can be engaged in to further the understanding of special nutritional requirements in IBD to facilitate the regulatory framework. Chantal Martineau, Health Canada Martineau explained that the Bureau of Nutritional Science at Health Canada has the responsibility to develop and update regulations related to foods for special dietary use.
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From page 110... ...
brought together a working group, the Food for Health Initiative, with members from the academic community, nutrition and health organizations, patient groups, industry stakeholders, and many others to look at nutritional requirements for those living with disease or certain medical conditions from a nutrition science perspective. A nutritional requirement to meet or restore desired health outcomes for one individual may vary quite drastically from that of another individual living with the same disease or medical condition, and so there are many considerations at play.
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From page 111... ...
nutritionfocused physical exams and composite nutrition diagnostic tools, such as subjective global assessment and malnutrition clinical characteristics, in their research across different states.
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