NuVal-& the Overall Nutritional Quality Index (ONQI)-

David L. Katz, MD, MPH, FACPM, FACPDirector, Prevention Research Center

Yale University School of Medicine

Principal Inventor, ONQIChief Science Officer, NuVal, LLC

www.davidkatzmd.com

IOMPublic Forum

Washington, D.C.4-9-10

Good advice-

n “Eat food, not too much, mostly plants.”n Michael Pollan

…that’s hard to swallow-

And clearly isn’t going down:

Blanck HM, Gillespie C, Kimmons JE, Seymour JD, Serdula MK. Trends in fruit and vegetable consumption among U.S. men and women, 1994-2005. Prev Chronic Dis. 2008;5:A35. Epub 2008 Mar 15

Katz DL. Plant foods in the American diet? As we sow... Medscape J Med. 2009;11(1):25. Epub 2009 Jan 26

What…FDA or IOM might have done:

n July, 2003q Katz DL. A food supply for dummies. Op-Ed: Hartford Courant;

NY Newsday; etc. 10/03

n Feb, 2006: If you want something done…§ and the rest is history…

ONQI Scientific Expert/Development Panel

n Chair: Dr. David Katz, Yale University School of Medicine

n Dr Keith Ayoob, Albert Einstein College of Medicinen Dr Leonard Epstein, University of Buffalo; inventor, Traffic Light Dietn Dr David Jenkins, University of Toronto; inventor, Glycemic Indexn Dr Francine Kaufman, USC; Past President, American Diabetes Associationn Dr Robert Kushner, Northwestern Universityn Dr Ronald Prior, Arkansas Children’s Nutrition Center, USDA HNRCn Dr Rebecca Reeves, Past President, American Dietetic Associationn Dr Barbara Rolls, Pennsylvania State Universityn Dr Sachiko St. Jeor, University of Nevadan Dr John Seffrin, President & CEO, American Cancer Societyn Dr Walter Willett, Harvard University

q 16 invitations extended; 14 acceptances

q Project Coordinators: Debbie Kennedy, PhD; Zubaida Faridi, MD, MPH: PRCq Statistician/Data Analyst: Valentine Njike, MD, MPH: PRCq Dietitians: Judy Treu, MS, RD; Lauren Rhee, MS, RD: PRC

n Others consulted

IOM Q & A

Q1

n Which scientific and authoritative statements/guidance documents were considered in developing the system? Which ones were eventually used in setting criteria and why? Which ones were not used and why?

A1n Dietary Reference Intakes, IOM

q http://fnic.nal.usda.gov/nal_display/index.php?info_center=4&tax_level=2&tax_subject=256&topic_id=1342

n Dietary Guidelines for Americans (2005)q http://www.health.gov/dietaryguidelines/

n NFP q http://www.fda.gov/Food/LabelingNutrition/ConsumerInformation/U

CM078889.htm

n WHO Dietary Recommendationsq http://www.who.int/nutrition/topics/nutrecomm/en/index.html

n Peer Reviewed LiteratureKatz DL, Njike VY, Faridi Z, Rhee LQ, Reeves RS, Jenkins DJ, Ayoob KT. The stratification of foods on the basis of overall nutritional quality: the overall nutritional quality index. Am J Health Promot. 2009 Nov-Dec;24(2):133-43

Q2

n How was the decision made to include some nutrients and not others?

The ONQI Algorithm-Numerator DenominatorFiberFolateVitamin AVitamin CVitamin DVitamin EVitamin B12Vitamin B6PotassiumCalciumZincOmega-3 fatty acidsTotal bioflavanoidsTotal carotenoidsMagnesiumIron

Saturated fatTrans fatSodiumSugarCholesterol

•Macronutrient FactorsFat qualityProtein qualityGlycemic loadEnergy density

•Trajectory Scores•Weighting Coefficients

Categorical stipulations

• Pure foods vs. processed

• Intrinsic vs. added sugars

• Artificial sweeteners• Etc.

A2

n Initial Considerations: Convention & Theory

q Inclusion on NFPq Strong support in peer-reviewed literatureq Highly relevant to public healthq Vital feature of some commonly consumed foodq Translation of ‘food level’ guidancen e.g.- whole grains; dark green/orange vegetables

Katz DL, Njike VY, Faridi Z, Rhee LQ, Reeves RS, Jenkins DJ, Ayoob KT. The stratification of foods on the basis of overall nutritional quality: the overall nutritional quality index. Am J Health Promot. 2009 Nov-Dec;24(2):133-43

A2, cont.

n Final Decisions: Empiricismq Correlation with expert consensusq Diet stratificationq Correspondence to HEI-2005q Association with health outcomes

q Katz DL, Njike VY, Faridi Z, Rhee LQ, Reeves RS, Jenkins DJ, Ayoob KT. The stratification of foods on the basis of overall nutritional quality: the overall nutritional quality index. Am J Health Promot. 2009 Nov-Dec;24(2):133-43

q Katz DL, Njike VY, Rhee LQ, Reingold A, Ayoob KT. Performance characteristics of NuVal and the Overall Nutritional Quality Index (ONQI). Am J Clin Nutr. 2010 Apr;91(4):1102S-1108S

Harvard Study

n FFQs from ~110,000 men and women

n NuVal scores assigned to every food

n NuVal scores were aggregated to the level of total diet, dividedinto quintiles

n Multivariate models adjusted for: q age, calories, smoking, BMI, aspirin use, exercise, vitamin E

supplementation, menopausal status, menopausal hormone use, family history of MI or cancer, and history of high cholesterol or blood pressure

Nurses Health Study: NuVal vs. HEI-2005; n = ~70,000

NuVal, Quintile 5

HEI-2005, Quintile 5

RR of chronic disease 0.86 (0.82-0.90) 0.88 (0.83-0.92)

RR of CVD 0.77 (0.69-0.86) 0.83 (0.75-0.93)

RR of diabetes 0.79 (0.71-0.87) 0.90 (0.81-1.00)

Chiuve S, Willett WC et al. Harvard School of Public Health

HPFS: NuVal vs. HEI-2005; n = ~40,000

NuVal, Quintile 5

HEI-2005, Quintile 5

RR of chronic disease 0.85 (0.81-0.90) 0.86 (0.81-0.92)

RR of CVD 0.77 (0.69-0.85) 0.80 (0.72-0.89)

RR of diabetes 0.77 (0.67-0.88) 0.94 (0.82-1.08)

Chiuve S, Willett WC et al. Harvard School of Public Health

NuVal & mortality, n = 110,000

n RR of all-cause mortality, top vs. bottom quintile of NuVal scores

q NHS: RR = 0.88; p<0.001 (n ~ = 70,000)q HPFS: RR = 0.87; p = 0.001 (n ~ = 40,000)

Chiuve S, Willett WC et al. Harvard School of Public Health

Q3

n What factors were involved in determining any food categories that are used in the system and the definition of these categories? If categories are not used, why?

A3n Initial Considerations: Convention & Theoryq The supermarket ‘aisle’q Nielsen IRIq Fundamental nutritional distinctions: e.g., direct-from-

nature vs. processed/fortified; ‘artificially’ sweetened

n Final Decisions: Empiricism

q Katz DL, Njike VY, Faridi Z, Rhee LQ, Reeves RS, Jenkins DJ, Ayoob KT. The stratification of foods on the basis of overall nutritional quality: the overall nutritional quality index. Am J Health Promot. 2009 Nov-Dec;24(2):133-43

q Katz DL, Njike VY, Rhee LQ, Reingold A, Ayoob KT. Performance characteristics of NuVal and the Overall Nutritional Quality Index (ONQI). Am J Clin Nutr. 2010 Apr;91(4):1102S-1108S

Q4

n How does the system deal with fortification?

A4n Unrestricted credit for nutrients in pure, direct-

from-nature foodsn Capping applied* to nutrient credit in fortified

foodsq TS capped at 4 following range testing / sensitivity analysisq ‘functional food’ exceptions, e.g., vitamin D in dairy

n Empirical confirmation

q Katz DL, Njike VY, Faridi Z, Rhee LQ, Reeves RS, Jenkins DJ, Ayoob KT. The stratification of foods on the basis of overall nutritional quality: the overall nutritional quality index. Am J Health Promot. 2009 Nov-Dec;24(2):133-43

q Katz DL, Njike VY, Rhee LQ, Reingold A, Ayoob KT. Performance characteristics of NuVal and the Overall Nutritional Quality Index (ONQI). Am J Clin Nutr. 2010 Apr;91(4):1102S-1108S

Q5

n In cases where nutrients are included that are not part of the Nutrition Facts Panel (e.g., added sugars), what factored into the decision to include these nutrients, and how is compliance measured?

A5n Derivation from dietary guidelines

q e.g., added sugar

n Translation of ‘food level’ guidance into quantifiable, algorithm entryq e.g., whole grains; ‘brightly colored’ fruits and vegetables

n Food supply reality checks:q diet soda vs. waterq salmon vs. chickenq dark chocolate vs. milk chocolate

n Empirical confirmationq Katz DL, Njike VY, Faridi Z, Rhee LQ, Reeves RS, Jenkins DJ, Ayoob KT. The stratification of

foods on the basis of overall nutritional quality: the overall nutritional quality index. Am J Health Promot. 2009 Nov-Dec;24(2):133-43

q Katz DL, Njike VY, Rhee LQ, Reingold A, Ayoob KT. Performance characteristics of NuVal and the Overall Nutritional Quality Index (ONQI). Am J Clin Nutr. 2010 Apr;91(4):1102S-1108S

WHEAT FLOURNIACINREDUCED IRONTHIAMINERIBOFLAVINFOLIC ACIDSOYBEAN OILSUGARCOTTONSEED OILSALTBAKING SODAHF CORN SYRUPSOY LECITHINNATURAL FLAVORCORNSTARCH

10 g1 mg2 mg1 mg

.5 mg24 mg1 g

.75 g.5 g

135 mg120 mg100 mg

70 mg40 mg10 mg

INGREDIENTS: ENRICHED FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE [VITAMIN B1], RIBOFLAVIN [VITAMIN B2], FOLIC ACID), SOYBEAN OIL, SUGAR, PARTIALLY HYDROGENATED COTTONSEED OIL, SALT, LEAVENING (BAKING SODA AND/OR CALCIUM PHOSPHATE), HIGH FRUCTOSE CORN SYRUP, SOY LECITHIN (EMULSIFIER), NATURAL FLAVOR, CORNSTARCH.

“Recipe”Development(imputation)

NutrientProfile

A5, cont.NuVal Nutrient String Generation-GCRC, Massachusetts Institute of TechnologyImputational Software: NCC, U Minn

RECIPE

Q6

n How will the system be updated with advances in science and changes in authoritative statements/guidance?

2010 Dietary

Guidelines

2010 Dietary

Guidelines

SAB Suggested

Topics from on-going lit review

SAB Suggested

Topics from on-going lit review

Finalize Review Areas

Finalize Review Areas

Assign ResearchAssign

ResearchPresent FindingsPresent Findings

DeterminePotential Changes

DeterminePotential Changes

Modify AlgorithmModify

Algorithm

Review Scores;

validation testing

Review Scores;

validation testing

Approve version 2.0Approve

version 2.0Update

ONQI DocUpdate

ONQI Doc

22Repeat as neededRepeat as needed

SAB / PRC ProcessSAB / PRC Process

1 of 3

Develop Comm. Plan

Develop Comm. Plan

Retailer Notification

Retailer Notification Develop PlanDevelop Plan Execute PlanExecute Plan

22Develop

Consumer Communication

Develop Consumer

Communication

Influencer Communication

Influencer Communication

Store Communication

Store Communication Execute PlanExecute Plan

Social Media CommunicationSocial Media

Communication Execute PlanExecute Plan

Develop PlanDevelop Plan Execute PlanExecute Plan

NuVal ProcessNuVal Process

2 of 3

Time Line & ConstraintsTime Line & ConstraintsRelative Calendar

SAB / PRCSAB / PRC NuValNuVal

NuValNuVal RetailerRetailer

Blackout Times – Retailer Rollout

Typical Blackout Period

3 of 3

ONQI Scientific Advisory Board

q Dr. David Katz, Ex Officio, Yale University

n Dr. Keith Ayoob, Chair, Albert Einstein College of Medicine

n Dr. Leonard Epstein, University of Buffalo; inventor, Traffic Light Dietn Dr. David Jenkins, University of Toronto; inventor, Glycemic Indexn Dr. Sonia Caprio, Yale Universityn Dr. Rebecca Reeves, Past President, American Dietetic Associationn Dr. Gail Frank, California State Universityn Dr. Eric Decker, University of Massachusetts; food science

NuVal conclusions:

n Uniquely independent, at inception & forevern We trusted (the SEP), but verified

q Founded in convention & theoryq Proven empirically:

n NuVal scores better predicted total chronic disease & all-cause mortality in 110,000 people over 20 yrs than the HEI-2005

n Early returns from PoP: the needle is movingn Designed to evolven Not hypothetical: >45,000 foods scored, matched to UPCs,

more dailyn Rapidly increasing uptake indicative of appeal/utility

Thank you!

David L. Katz, MD, MPH, FACPM, FACPDirector, Yale Prevention Research CenterPresident, Turn the Tide Foundation, Inc.

130 Division St.Derby, CT 06418(203) 732-1265

David.katz@yale.eduwww.davidkatzmd.com

www.nuval.com