a more effective national food and nutrition policy

More Effective National Food and Nutrition Policy:

Balancing the Role of Research, Nutrition Science, and Public Health

© 2015 Institute of Food Technologists

Presenters:

Joanne Slavin, PhD, RD, University of MinnesotaThe Widespread Effects of Food and Nutrition Policy on Public Health► Segment takes a look back at the history of the Dietary Guidelines

for Americans and how they have progressed over the past 35 years

Today we will hear from…

Moderator: Elizabeth CrawfordSenior Correspondent, Food Navigator-USA

2


Connie M. Weaver, PhD, Purdue UniversityThe Importance and Deficiencies of Consistent, Systematic Evaluation Processes in Policymaking► Examination of the evaluation processes used by policymakers and

provided examples of how differences among these processes can lead to varying results

Roger Clemens, DrPH, University of Southern CaliforniaThe Role of Scientific Research in Food and Nutrition Policy► An exploration of the different types of research used to set nutrition

policy and how varying strengths of this research often lead scientists to presume outcomes that may not hold true after stronger research emerges

3

Joanne Slavin, PhD, RDProfessor

Department of Food Science and NutritionUniversity of Minnesota

[email protected]

The Widespread Effects of Food and Nutrition Policy on Public Health

Disclosures for Joanne Slavin

AFFILIATION/FINANCIAL INTERESTS

(past 12 months)

CORPORATE ORGANIZATION

Grants/Research Support: American Pulse Association

Scientific Advisory Board/Consultant:

Tate and Lyle, Atkins, Kelloggs

Speakers Bureau:

Stock Shareholder:

Other

© 2015 Institute of Food Technologists 5

From Science to Me

The Science Policy Me


http://www.nap.edu/catalog/9810.html







There is no perfect diet!

► Humans are omnivores, like pigs, and are adaptable to a wide range of foods

► Humans have survived and prospered on all kinds of diets, mostly reflecting access to food supply

• Traditional Arctic diet: 80% of kcals from fat

• Traditional African diet: 80% of kcals from carbohydrate

► Because of concerns with fat and cardiovascular disease, U.S. diet has moved from higher fat (42% of kcal in 1972) to lower fat (32% of kcal in 2000) – but more calories


Dietary Guidance—A Historical Perspective

1894 - Dr. W.O. Atwater specified amount of protein and total calories in a good diet,

but left unspecified the division of calories between fats and carbohydrates

1902 - “evils of overeating may not be felt at once, but sooner or later they are sure

to appear – perhaps in general debility, perhaps in actual disease”

1902 - “ordinary food materials…make a fitting diet, and the main question is to use

them in the kinds and proportions fitted to the actual needs of the body”

Recommended variety, proportionality and moderation, measuring calories,

and an affordable diet focused on nutrient-rich foods, less fat, sugar and

starch.


Nutritional science – nutrients to prevent deficiency diseases

1941: National Academy of Sciences began issuing “Recommended

Dietary Allowances” – quantity of nutrients a person needed to

consume daily to ensure basic good health, proper growth and

reproductive success, and to prevent nutrient deficiency diseases. Nutritional deficiency diseases have been virtually eliminated in

the U.S., thanks to enrichment of refined grains and other

fortification strategies.


Nutrient Adequacy

Meet nutrient needs without exceeding calorie needsDietary Reference Intakes (DRIs)

• Acceptable Macronutrient Distribution Ranges (AMDR) - Protein: 10 - 35% of kcal

- Carbohydrates: 45 - 65% of kcal

- Fat: 20 - 35% of kcal

• Recommended Dietary Allowance (RDA)

• Adequate Intake (AI)

• Tolerable Upper Level Intake (UL)


Senate Select Committee on Nutrition and Human Needs – Dietary Goals the United States (1977)

► Increase carbohydrates to 55%–60% of energy► Reduce fat to 30% of energy► SF, MF, PUFAs – 10%/10%/10%► Reduce cholesterol to 300 mg/day► Reduce sugar consumption by 40%► Reduce salt consumption to 3 g/day – 1200 mg

sodium


Toward Healthful Diets, FNB, 1980

“The Board expresses its concern over excessive hopes

and fears in many current attitudes toward food and

nutrition. Sound nutrition is not a panacea. Good food that

provides appropriate proportions of nutrients should not be

regarded as a poison, a medicine, or a talisman. It should

be eaten and enjoyed.”


Dietary Guidelines for Americans 1980 - 2010

1980

1985

1990

1995

2000

2005

2010


DGAC Advisory Report submitted to the

Secretaries of USDA & HHS

USDA & HHS write the

Policy Document

DGAC is chartered DG’s

implemented through Federal

programs

DGAC Charter

DGAC Public Meetings:

Review of the Science

Evidence-based Methodology Used to Review the Science

Public comments encouraged/collected

Dietary Guidelines for Americans,

2010

(TBD)

U.S. Department of AgricultureU.S. Department of Health and

Human Serviceswww.dietaryguidelines.gov

The New

“Pyramid”

Development of Dietary Guidelines Policy


Total Diet 2010 DGAC Conclusions: Not Evidence-Based

Key Topics: Overweight/obese nation Develop healthy dietary patterns in childhood and

adolescence Maintain energy intake within calorie needs Maximize nutrient density by emphasizing whole grains,

vegetables, fruits, milk/milk products, and oils Reduce solid fats and added sugars and sodium Flexible eating patterns


Chapter 3Foods and Food Components to Reduce


Chapter 4Foods and Nutrients to Increase


Comparison of Consumption to Recommendations


DGAC 2015

► “Settled science” – may not see much change on nutrient levels

► Movement to whole foods and away from nutrients► Topics such as sustainability, gluten, vegan diets,

and food processing have been discussed and may be included in 2015 DGA


2015 DGAC – Dietary patterns, foods and nutrition, and health outcomes

► The US population should consume dietary patterns that are:• Rich in vegetables, fruits, whole grains, fish/seafood,

legumes, and nuts

• Moderate in dairy products (e.g. low and non-fat dairy) and alcohol and

• Lower in red and processed meat and

• Low in sugar-sweetened foods and beverages and refined grains


2015 DGAC – Food and nutrient intakes, and health: Current status and trends

► The US population has low intakes of certain key nutrients – vitamin D, potassium, fiber, calcium, and for females also iron. These low intakes are a public health concern because inadequate intakes are linked to health problems

► The US population over consumes sodium and saturated fat. Excess intakes of these nutrients are also linked to health problems

► Many of the food groups that are good sources of under consumed nutrients are consumed in low amounts by the US population

► Many of the food groups and food categories that have high levels of sodium, saturated fat, and added sugars are consumed in high amounts


1943: Basic Seven

Margaret Mead: “People don’t eat nutrition – they eat food”

Basic 7 did not specify the number of servings of each food group needed daily


1940s1950s-1960s

1970s1992

Food for Young

Children

1916

2005

Food advice: Evolution of USDA’s Food Guidance – Moderation and Variety


MyPlate.gov (6/2/11)


Key Takeaways

► Evidence-based reviews are limited in our ability to define “healthy foods”

► Recommendations for less added sugar and solid fats are based on empty calories, not health outcomes – USDA modeling

► Since nutrition research does not support that vegetarian diets are healthier than animal based diets, there is a movement to “sustainability” as the reason to support plant-based diets

► Solving important nutrition problems will require partnerships based on trust among academics, the government, commodity groups, and food companies


Connie M. Weaver, Ph.D.Purdue UniversityWest Lafayette, IN

[email protected]

The Importance and Deficiencies of Consistent, Systematic Evaluation

Processes in Policymaking

Disclosures for Connie Weaver


(past 12 months)


Grants/Research Support: NIH, DRI, Nestle, Tate & Lyle


NOF, ILSI, Showalter, Pharmavite

Speakers Bureau:

Stock Shareholder:

Other


Outline

► Evidence-based approach

► Difficulties encountered with evidence-based approach in nutrition

Consensus Development for

Public Health Guidelines

Science has produced unbiased, evidence-based

assessments of controversial medical issues important

to researchers, healthcare providers, policymakers,

patients, and the general public. The consensus

statements interpreting the available evidence and has

identified research gaps to guide future research. The

consensus statements have been used by numerous

professional organizations to develop guidelines.


























The Philosophy Behind an Evidence-based System

► Rules are set “up front” then followed, rather than having a preconceived idea and then finding the papers to support the idea.

► If one follows the rules, any trained scientist should come to the same conclusion.


Hierarchy of Evidence

RCT

Double Blinded RCT

Cohort Study Case Control Case Series Case Report

Expert Opinion

Weaker Evidence

Stronger Evidence

Evidence-based Medicine Hierarchy

Consistency ends here!


No Consistent Literature Retrieval or Grading Systems

► NIH-AHRQ

► FDA-own system for health claims

► Various other approaches

Slavin Nutr J 14:15, 2015


Nutrition Evidence Library (NEL) Process

Define Research Recommendations

Dietary Guidelines Advisory Committee Since 2010:

Summarize and Synthesize

the Evidence• Assess quality

of individual studies

• Assess applicability

• Summarize and synthesize

evidence

Develop and Grade ConclusionStatements

Formulate Systematic

Review Questions• Exploratory

searches• Public comment

• Dialogue with experts

• AnalyticalFramework

• PICO

Literature Search and

Sort• Identify study eligibility criteria

• Determine search strategy

• Search for relevant studies• List included

studies• List excluded

studies and rationale

ExtractEvidence

From Studies

Create evidence

worksheets


Grade Strength of Evidence► Quality

• Scientific rigor and validity

• Consider study design and execution

► Quantity

• Number of studies/sample sizes

► Consistency of findings across studies ► Impact

• Importance of studied outcomes/magnitude of effect

• Magnitude of effect

► Generalizability

Grades: 1.STRONG; 2. MODERATE; 3. LIMITED


Search term + bone + child + adolescence Excluded: reviews, animal studies, non-English Subcommittees reviewed abstracts and

excluded• If not RCT or observational study

• No bone outcomes

• Interventions <6 mo.

• Drug trials of disease states

ASN Scientific StatementsExample of Development of Peak Bone Mass

PubMed search of scientific literature Jan 2000-Dec 2014


Level of Evidence DescriptionA: Strong One large, well-conducted, generalizable, RCT

ORMultiple RCTs or trials with few limitations

B: Moderate Multiple prospective cohort studies.ORMeta-analysis of prospective cohort studies.

C: Limited Multiple prospective cohort studies from diverse populations that have limitations.OROne well-designed prospective study.ORMultiple cross-sectional or case-controlled studies with few limitations.ORMeta-analysis with design limitations.

D: Inadequate Methodologic flaws ORInsufficient data.

Evidence Grade


35

Differences in process for evaluating scientific evidence can

lead to different conclusions

Example: Choosing different end points concern over salt


2010 Dietary Guidelines Advisory Committee Conclusions

► A strong body of evidence has documented that in adults, as sodium intake decreases, so does blood pressure.

► A moderate body of evidence has documented that as sodium intake decreases, so does blood pressure in children, birth to 18 years of age.

► The reduction from 2,300 mg to 1,500 mg per day should occur gradually over time. [about 750 mg/1000kcal]


IOM Committee on Consequences of Sodium Reduction in Populations

– Released May 14, 2013

Calls for national action to reduce sodium content of foods - average intake 3400 mg Na/d

Evidence weak to strive for less than 2300 mg Na/d – need more studies between 1500 and 2300 mg/d

Focused on disease outcomes beyond blood pressure


2015 DGAC

Sodium Recommendations<2300 mg/day


There is NO guarantee of consensus conclusions even if you use same process and end

points


What is the Relationship Between Calcium and Vitamin D and Hip Fracture?

Women’s Health Initiative RCT of CaD(n=68,719 postmenopausal women)

Prentice et al., Osteopor Int 24:567, 2013

• All subjects including those taking own supplements

• >5 Year CaD Intervention-related Health Outcomes in Subjects Adherent & Not Taking Baseline Supplements

No relationship

Large benefit


Difficulties of Applying Evidence-Based Medicine

Approach to Nutrition


Ranking of Study Type

► The RCT is given greatest weight because it is the only design that permits strong causal inference

► But for nutrition, that often means sacrificing control of the independent variable (nutrient diet) in favor of the dependent variable (health outcome)


RCT Trials are Designed for a Compound That:

Works quickly

Usually pinpointed to 1 pathway or 1 mechanism of action

That is: a drug


Features of RCTs for Drugs

► Tested in or applied to sick people► Test agent is contrasted with its absence

compared to a nutrient where there can be no nutrient-free state

► Sharply defined primary outcome measure► Effect size usually large compared to a nutrient► Response characteristic is usually monotonic

across plausible intakes


Contrasts

► Drug – drug-added state is contrasted with drug-free state

► Nutrient – “high” intake is contrasted with “low” intake


Effect Size

► Drug- usually large

► Nutrient – usually small, but•public health impact may nevertheless be large•aggregate effect across multiple •systems is itself often large


Consequence

► When changes are small, testing for isolated nutrient effects requires large, expensive, lengthy studies if effects in isolated systems are to be found statistically significant.


INTAKE

EFFE

CT

Study Design & the Threshold

the control group must be

deficient


The Ethical Problem

► Placing the control group on a clearly inadequate intake

Ethically acceptable?


Underreporting error for energy intake in overweight boys and girls was 35+18%E

I as

% o

f TE

E

Girls Boys

Reported EIWeight adjusted MEITEE by DLW

Singh, 89(6):1744-1750, 2009

Concern with Diet Assessment for Observational Studies


Controlled Feeding Studies

► Historically ranked highest for evidence for nutrients/diet

► Minimizes confounders and allows study of range of known intakes


Animal Studies

► Can have controlled diet and sufficiently long duration for cancer outcome measures.

•But relevance to humans?

► Invasive procedures► Mechanistic


Future Needs

► Good biomarkers are the most needed tool in research related to diet and health. Current biomarkers for intake and health outcome measures range from weak to moderately good. Even the better ones need validation.


Kinds of Evidence

Basic Research

Translational Research

EfficacyStudies

Effectiveness Research

How does it work?

Can it be studied in people?

Specific effects?

How good is the

translation?


Best recommendations use the totality of

evidence with liberal doses of critical thinking

and LOGIC!


The Role of Scientific Research in Food and Nutrition PolicyRoger Clemens, DrPH, CFS, CNS, FACN, FIFT, FIAFST

Adjunct Professor, Pharmacology and Pharmaceutical Sciences USC School of Pharmacy, Los Angeles

[email protected]

The Role of Scientific Research in Food and Nutrition Policy

Disclosures for Roger Clemens


(past 12 months)


Grants/Research Support: None


Spherix Consulting, Mushroom Council, Almond Board of California, California Walnut Commission, Abbott Nutrition,

FMC, Numerous Law Firms

Speakers Bureau: IFT, ASN

Stock Shareholder: None

Other Daedalus Humanitarian/Foundation


► Improve health through food

► Provide food that is safe, nutritious, affordable and accessible

► Implement consistent policy

► Establish dietary clear guidelines

Dietary Guidelines and Global Imperatives

• Need health literacy• Need developmental

approach to dietary guidelines

• Need to recognize nutrition needs

throughout life cycle• Need applied research

based on food• Need public/private

partnerships • Need to shift cultures of

health


► Over 35 years, increased prevalence of NCD

► Medical expenses associated with obesity: $200-300B

► > $100B spent on nutrition assistance programs~ 70% of SNAP support families with children

► ~24MM people in low income

► ~20% children are food insecure

► Food and inactivity leading contributors of death in the USA

J. Michael McGinnis, M.D., M.A., M.P.P., IOM Senior Scholar, May 21, 2015

► Agriculture is responsible for much of the progress humanity has made against hunger. The only way that the world can keep up with food production is by the improvement of science and technology.

Norman Borlaug, Nobel Laureate, 1970

Health Today


► Examine the Dietary Guidelines for Americans, 2010 and determine topics for which new scientific evidence is likely to be available that may inform revisions to the current guidance or suggest new guidance.

► Place its primary focus on the systematic review and analysis of the evidence published since the last DGAC deliberations.

► Place its primary emphasis on the development of food-based recommendations that are of public health importance for Americans ages 2 years and older.

► Prepare and submit to the Secretary of Health and Human Services and the Secretary of Agriculture a report of technical recommendations, with rationales, to inform the development of the 2015 Dietary Guidelines for Americans. DGAC responsibilities include providing authorship for this report; however, responsibilities do not include translating the recommendations into policy or into communication and outreach documents or programs.

Charge to the 2015 DGAC

http://www.health.gov/dietaryguidelines/2015-binder/2015/chargeCommittee.aspx June 2013 © 2015 Institute of Food Technologists 62

http://www.health.gov/dietaryguidelines/2015-binder/2015/chargeCommittee.aspx

http://www.health.gov/dietaryguidelines/2015-binder/2015/chargeCommittee.aspx

Assessing the Evidence

► Observational claims are not necessarily validated via clinical trials.

► Clinical studies among small populations do not necessarily translate to total population (think public policy)

► Common words like “association,” “related,” and “relative risk” imply strength, yet upon review the work is generally quite weak

► “Definitive solution will not come from another million observational papers or a few small randomized trials”

Ioannidis JPA BMJ 2013;347: doi: 10.1136/bmj.f6698© 2015 Institute of Food Technologists 63

► Systematic reviews and meta-analyses

• Different inclusion/exclusion criteria impact results

• Different statistical approaches and choices of

covariates impact results

• Dietary exposures are not accurate

• Associations Causes

• Reflect the perspectives of others

Research Bias

Nicklas et al., J Nutr 2014; doi: 10.3945/jn.114.194068


It is…important to not be distracted by questions that we have not been asked to address.

What was Asked?

What’s missing in many [meta analysis and systematic review] studies published since 2010 DGAC?

Undefined and inconsistent outcomes

Intention to treat analysis Complete case analysis

Unexplained discontinuances Imputed baseline data extended

beyond current analysis Multiple imputations in analyses


Kaiser et al. Obes Rev 2013; doi: 10.1111/obr.12048.

Ecological Relation of Water Intake with Prevalence of Overweight/Obesity: 1961-2000

Rise in obesity rates (round markers) and bottled water consumption (square markers). USA


Consumer Confusion

ConfidenceConfusion

IFIC 2012:• Three out of four consumers feel that changes in nutritional

guidance makes it hard to know what to believe

• Half believe it is easier to do their own taxes than to figure out how to eat healthfully

International Food Information Council Foundation 2012 Food & Health Survey . Consumer Attitudes Toward Food Safety, Nutrition & Health http://www.foodinsight.org/Content/3840/2012%20IFIC%20Food%20and%20Health%20Survey%20Report%20of%20Findings%20(for%20website).pdf


Do Scripted Diets Work for Policy?What about Low-fat Diets?

2015 DGAC Meeting 5, September 16, 2014© 2015 Institute of Food Technologists 68

Comments► Chowdhury: “My take on this would be that it’s not saturated fat that

we should worry about” in our diets.

► Hu: The findings should not be taken as “a green light” to eat more steak, butter and other foods rich in saturated fat. … looking at individual fats and other nutrient groups in isolation could be misleading, because when people cut down on fats they tend to eat more bread, cold cereal and other refined carbohydrates that can also be bad for cardiovascular health.

► Hu: “The single macronutrient approach is outdated. I think future dietary guidelines will put more and more emphasis on real food rather than giving an absolute upper limit or cutoff point for certain macronutrients.”

► Hu: People should try to eat foods that are typical of the Mediterranean diet, like nuts, fish, avocado, high-fiber grains and olive oil.

Rajiv Chowdhury, PhD

Cardiovascular Epidemiologist

University of Cambridge

Frank Hu, MD, PhDProfessor of Nutrition and

EpidemiologyHarvard University

http://acsh.org/2014/03/huge-new-re-evaluation-saturated-fat-heart-risk-finds-link/March 18, 2014


► Cholesterol is not a nutrient of concern for overconsumption.

► Saturated fat is still a nutrient of concern for overconsumption, particularly for those older than the age of 50 years.

Dietary Cholesterol and Saturated Fat


► There is insufficient evidence that an exchange of sugar for non-sugar carbohydrates results in lower body weights (a calorie = a calorie)

► Observational (cross-sectional) studies suggest a possible relationship between consumption of sugar-sweetened beverages (SSB) and body weight; no supporting RCTs

► Insufficient evidence to support a difference between liquid and solid sugar intake and body weight control

Added Sugars and Body Weight

Key reference: van Baak & Astrup. Obes Rev 2009; 10 Suppl 1:9-23


Agency Statement2010 DGAC RCTs report that added sugars are not different from

other calories in increasing energy intake or body weight. Systematic reviews in this area are also inconsistent.

EFSA 2012 …a cause and effect relationship has not been established between total sugar intake and body weight gain

WHO 2015 (Te Morenga et al, 2014)

‘Trials in children, which involved recommendations to reduce intake of sugar sweetened foods and beverages, had low participant compliance to dietary advice; these trials showed no overall change in body weight.’

German Nutrition Society 2012

In general, meta-analyses are inconsistent. The most recent meta-analysis concludes that the risk-increasing effect is limited to individuals with initially already increased BMI or existing overweight, respectively

Sugar in Context


Food, Nutrition & Health

► Secondary Education Challenge

► Community Food Projects► Higher Education Challenge► 1890 Capacity► Food Safety, AFRI► Climate Variability and Change,

AFRI► Food Security, AFRI► Foundational Program, AFRI► Alaska Native & Native

Hawaiian Institutions

► Federally Recognized Tribes Extension Program

► Hispanic-Serving Institutions Education

► Multicultural Scholars► National Needs Graduate

Fellowships► New Technologies for Ag

Extension► Rural and Community

Development, SBIR► Tribal Colleges Education

Equity► Tribal Colleges Extension► Tribal Colleges Research


► FDA Investment• Further scientific knowledge about

potential food hazards

• Expand on best safety practices• Better understand how consumers access,

prepare, and use the foods they serve and eat

► CFSAN Research Strategic Plan• Globalization of the food supply chain• Changing industry processes• Consumer preferences for fresh and

minimally processed foods

Science & Research (Food)

Where’s Food Science and Nutrition?

Where’s Agriculture?


►Criteria for NNMAC representation (Title II)– At least two representatives selected solely on basis of

established record of distinguished service and eminence in many disciplines and fields (>20)• Various geographical areas• Private sector• Academia• Scientific and professional societies• Agriculture• Minority organizations• Public interest organizations, and• State or local government employee with a specialized

interest in nutrition monitoring

1990 National Nutrition Monitoring and Related Research Act, Title III (P.L. 101-445)


Immediacy

Sustainability Resource management

(land, water, energy) Cultivars compatible with

climate dynamics Biodiversity Supply chain (e.g., grains,

fish price stability) Globalization of food

supply

R&D investment New technology and innovation

Political tension unstable food supply

Food security policy Poverty Inadequate food

Decline physical and mental development

Rural development hunger


► Urgency for public and personal health► Urgency for collaborative funding► Urgency for the next generation

Call to Action

“A coordinated strategic plan that includes all sectors of society, including individuals, families, educators, communities, physicians

and allied health professionals, public health advocates, policy makers, scientists, and small and large businesses (e.g., farmers,

agricultural producers, food scientists, food manufacturers, and food retailers of all kinds), should be engaged in the development and

ultimate implementation of a plan to help all Americans eat well, be physically active, and maintain good health and function.

It is important that any strategic plan is evidence-informed, action-oriented, and focused on changes in systems in these sectors” USDA


► Must interconnect in policymaking that extends beyond nutrition.

► Must leverage interdisciplinary expertise that embraces knowledge, technology and innovation plus sections outside of the food system to achieve a more encompassing food system

► Develop a strong evidence-based approach to decision making

► Engage global harmonization guidelines in regionally, culturally appropriate practices in food supply

Going Forward


► Need a White House conference: greater attention to consumers

► Need to consider food forms beyond fruits and vegetables

► Need to understand everyone has a role in promoting better food choices, while being sensitive to culture and tradition

► Need to provide safe, nutritious, affordable and accessible foods for everyone

► Need to encourage research funding that includes agriculture, applied community nutrition, human behavior across demographics, and consumer education

Going Forward


While Diet Is Linked to Health, Much Confusion Exists About What to Eat and Under What

Circumstances!!


Today’s session was organized by the Corn Refiners Association.

Thank you.


Any Questions?