Endpoints Differences when Considering Deficiency vs. Chronic Disease
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1 Endpoints Differences when Considering Deficiency vs. Chronic Disease Amanda MacFarlane, PhD Nutrition Research Division, Health Canada, Ottawa, ON
2 Dietary Reference Intakes Framework DRI values based on: Relationships between nutrient intakes and indicators of: Adequacy Adverse effects Data from apparently healthy populations Chronic disease (CD) risk reduction where sufficient data for efficacy and safety exist
3 Risk assessment approach to setting DRI values Demonstration of causality Hazard Identification = Causal Relationship Lit review & interpretation Identification & selection of indicator (endpoint) Intake-Response Relationship Hazard Characterization = Dose Response Establish model Dietary Reference Intake Intake Assessment Implications & Special Concerns
4 Assumptions of the DRI approach Essentiality of the substance Evidence of causality and intake response Threshold for adequacy and adverse effects Relevant population Biomarkers on causal pathway Evidence dictates the absolute nature of the risk Generally, DRI values only set for adequacy and adverse effects of high intakes Assumptions don t always apply to nutrient-cd relationships Only Adequate Intake values set based on CD endpoints 4
5 5
6 Assumption: Causal relationship between nutrient intake and endpoint Establishing causality and/or dose response RCT Intervention trials Metabolic/balance studies Depletion/repletion 3 doses (Intake-Response)
7 Nature of the evidence differs for CD Nutrient-CD evidence mostly associational Establishment of causality and/or dose response in absence of RCTs Inherent errors/bias associated with study type Confounding and selection bias Self-reported intake
8 Assumption: Biomarkers on causal pathway Direct observation of endpoint Disease of deficiency (EAR), adverse effect (UL) Indicators of status on the causal pathway for diseases of deficiency Eg. Serum folate, serum 25(OH)D, serum ferritin Higher level of certainty of relationship Exposure Indicators of exposure Clinical outcomes 8
9 CD risk: Use of surrogate or intermediate outcomes Nutrient-CD associations often determined using surrogate or intermediate outcomes Higher uncertainty Validated biomarkers (including for intake) are few 9
10 10
11 Assumption: Absolute risk affects all persons, all life-stage groups Absolute Risk Absolute Risk Depending on intake level, there is 0 or 100% risk of deficiency or adverse effects 11
12 All persons, all life-stage groups: Eg. Vitamin D and bone health IOM (Institute of Medicine) Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press. 12
13 CD risk: Not all persons or life-stage groups And often <<50% of population affected by the CD 13
14 CD risk: Often defined as Relative risk No one is at 0 or 100% risk they are at higher or lower risk compared to baseline risk Changes in relative risk can be small (eg. <10%) Options for basing Dietary Reference Intakes (DRIs) on chronic disease endpoints: report from a joint US-/Canadian-sponsored 14 working group. Am J Clin Nutr January 2017 vol. 105 no S-285S
15 Relative risk: Fibre and coronary heart disease BMJ 2013;347:f6879 Greatest effect often at tail(s) of intake distribution highest or lowest intakes have largest effect 15
16 Assumption: Threshold for adequacy Threshold effect/inflection point between inadequate and adequate intakes 16
17 CD risk: Absence of a threshold Nutrient-CD relationships can lack an inflection point Eg. Fibre and coronary heart disease BMJ 2013;347:f6879 Fibre AI based on median intake to achieve lowest relative CHD risk 17
18 Assumption: Threshold for upper intake Intake > UL increases the risk of adverse effects 18
19 CD risk: Absence of an upper threshold Nutrient-CD relationships can lack an inflection point Eg. Saturated fats and LDL cholesterol * also no benefit : Keep intakes as low as possible while consuming a nutritionally adequate diet IOM. Dietary Reference Intakes: Energy, Carbohydrates, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academies Press,
20 Assumption: Interval between beneficial and harmful intakes 20
21 Sodium and blood pressure - no threshold and benefit overlaps harm Relationship is linear at all doses NO UPPER THRESHOLD AI (1.5 g) based on adequacy for other nutrients and sweat losses UL (2.3 g) based on the next higher dose in trials 21
22 CD risk: Potential for overlap between benefit and harm A nutrient can be related to multiple chronic diseases with different/overlapping risk relationships 22 Options for basing Dietary Reference Intakes (DRIs) on chronic disease endpoints: report from a joint US-/Canadian-sponsored working group. Am J Clin Nutr January 2017 vol. 105 no S-285S
23 In summary The DRI approach works well for estimating adequate intakes/adverse effects for essential nutrients It has not worked well for CD endpoints CDs are complex and can be influenced by many factors including other food substances Assumptions used to define EAR/UL do not always apply Available evidence differs significantly from that available for establishing essentiality/toxicity 23
24 Acknowledgements Canadian Interdepartmental/Interagency DRI Steering Committee US DRI Subcommittee Canadian-US Joint DRI WG Steve Brooks (HC) Molly Cogswell (CDC) Janet de Jesus (NIH) Patricia D Ongia (HC) Krista Esslinger (HC) Linda Greene-Finestone (HC) Deborah Hayward (HC) David Klurfeld (USDA) Susan Krebs-Smith (NIH) Chris Lynch (NIH) Amanda MacFarlane (HC) Kathryn McMurry (NIH) Linda Meyers (NIH) Kristy Mugavero (CDC) Jessica Mullen (CDC) Rick Olson (HHS) Karen Regan (NIH) Jenna Seymour (CDC) Pam Starke-Reed Christine Taylor (NIH) Essie Yamini (FDA) Beth Yetley (NIH) DRI-Chronic Disease Workshop Co-Directors Beth Yetley (NIH) Amanda MacFarlane (HC) Linda Greene-Finestone (HC) DRI-Chronic Disease Workshop Panel Cutberto Garza (Chair) Jamy Ard Stephanie Atkinson Dennis Bier Alicia Carriquiry Janet King Daniel Krewski George Wells William Harlan Dale Hattis Deborah O Connor Ross L. Prentice Joseph V. Rodricks 24
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