regulating sugar: existing policies, trends, and scientific justification

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Regulating Sugar: Existing Policies, Trends and Scientific Justification William Fisher, IFT John White, White Technical Research Courtney Gaine, ILSI Roger Clemens, USC

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This session will review the history of sugar use, examining the types of sugars functions in foods, metabolic and physiologic function of sugars, intake and health effects and current gaps in related research. Additionally, it will examine the many policy issues facing sugars, specifically looking at the impacts labeling and tax initiatives could have on dietary practices. Both sides of the policy debate will be presented.

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Page 1: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Regulating Sugar: Existing Policies, Trends and Scientific Justification

William Fisher, IFT

John White, White Technical Research

Courtney Gaine, ILSI

Roger Clemens, USC

Page 2: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Objectives

Provide an in depth understanding of

– How the science of sugars has evolved

– What questions still remain– How interpretations of the science contribute to the policy

debate around sugars

– Both sides of the public policy debate on consumption of sugars

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Topics

Examination of types of sugars

– Historical data

– Functional benefits

– Composition

Examination of the Research

– Metabolic and physiologic functions

– Intake and health effects

– Research gaps

Examination of policy issues facing sugars

– Impacts of labeling

– Tax initiatives on dietary practices

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Speakers and Presentations

Regulating Sugar: Existing Policies, Trends and Scientific JustificationModerated by

William Fisher, CFS

Vice President, Science & Policy Initiatives, Institute of Food Technologists

Sugars in Food: History, Composition, Functionality and AvailabilityJohn S. White, PhD President and Founder, White Technical Research

State of the Science: Sugars Intake & HealthP. Courtney Gaine, PhD, RDSenior Science Program Manager, ILSI North America

Sweet Evidence on Dietary Guidelines and Public Health PolicyRoger A. Clemens, DrPH, CFS, CNS, FIFT, FACN, FIAFSTChief Scientific Officer, HornResearch Professor, USC School of Pharmacy

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Page 5: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Thank you

Page 6: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

John S. White, PhD

White Technical Research, LLC

Sugars in Food:History, Composition, Functionality and Availability

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Sugars in food: My perspective

33 years in Food & Beverage Industry Specialization in nutritive (caloric) sweeteners − sugars Misunderstandings abound Useful and safe ingredients when used in moderation

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Sugars in food: What are they?

Honey Sucrose (table sugar) High fructose corn syrup (HFCS) Fruit juice concentrates Agave nectar

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Sugars in food: Road map

History Composition Production Functionality Availability

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History: Honey

Discovery of Honey

Piero de Cosimo, 1462

Worcester Art Museum

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History: Sugar – BC

8,000 Sugarcane domesticated in New Guinea;spread to SE Asia, China and India

800 Early Chinese manuscripts first reference sugar and Indian sugarcane fields

500 Molded, cooled sugar syrup ‘bowls’ developed in India enabled regional transport

300 Alexander the Great brings “the sacred reed which gives honey without bees” on conquest of W Asia

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History: Sugar – AD

400 Granulated sugar developed during Golden Age of India;Sugar becomes a major trade item

500-600 Buddhist monks introduce sugar to China;Indian sailors expand sugar trade with Indian Ocean partners

600s Arabs acquire sugarcane after invading Persia; Sugarcane spreads throughout Mediterranean through further invasions, conquests and increasing trade

700-1200

Indian sugar production adopted during Arab Agricultural Revolution; Returning Crusaders bring “sweet salt”;Venetian merchants produce sugar in Tyre for export to Europe

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History: Sugar – AD

1300s Improved press doubles juice yield; sugar @ $75/lb (current value)

1400-1700

Spanish / Portuguese take sugarcane to Central/South America; Flemish refining/distribution competes with Venetians; Dutch explorers take sugarcane from South America to Caribbean

1700s Widespread cultivation/processing makes sugar more affordable; Caribbean has low-cost production – slave/indentured workforce; Steam powers Jamaican mills and heats extraction kettles

1800-1850

Sugar becomes a ‘necessity’ in beverages, preserves, confections, desserts, processed foods;Cuba is the richest Caribbean country – land, slavery, technology;Closed kettle vacuum pan reduces degradation reactions / energy;Multiple-effect evaporation and centrifugation introduced

1900-2000s Lost 50% of market share in US to HFCS; recovered to 60% >90% of global market: dominant worldwide sweetener

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Page 14: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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History: HFCS – AD

1807 First American wheat starch plant is built (NY); new uses expand global starch industry: textiles, paper, color printing and food thickeners

1811 Russian chemist Gottlieb Kirchoff converts non-sweet starch into sweet glucose via acid hydrolysis

1864 Union Sugar Company (NY) treats cornstarch with enzymes to make corn syrup; half the sweetness of sugar but a good thickener, more reliably available, cheaper than cane sugar and heavily-taxed molasses

1940 Alkaline isomerization of glucose to fructose patented by CPC;lacks commercially viability due to excessive sugar degradation

1957 CPC uses microbial isomerase to convert glucose to fructose; higher quality, domestic U.S. corn is more reliable, but isn’t economical

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History: HFCS – AD

1965-1967 Japanese isolate heat-stable xylose isomerase; make first HFCS (15% fructose) in joint venture with CPC

1968 HFCS-42 made batch-wise with immobilized and liquid enzymes

1974-1976 World shortages spur search for sugar replacement

1978 Moving-bed chromatographic separation of fructose from glucose enables production of HFCS-55

1981-1983 Staley research team identifies trace (ppb) differences in sugar and HFCS;full replacement of sucrose by HFCS in SSB

1984 HFCS approved at 100% sugar replacement level in Coke and Pepsi

1999 Peak year for HFCS use

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Page 16: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Sugars CompositionFRUCTOSE & GLUCOSE CONTENT as % of Total Simple Sugars

HFCS 42 Sugar Honey HFCS 55Grape Juice

Apple Juice Agave NectarPear Juice

0

10

20

30

40

50

60

70

80

16

Page 17: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Sugars Structures

• Sucrose bond broken (inverted) by acid and enzyme

• Post-digestion sugars similarities dictate similarities in functionality and metabolism

White JS. In: Rippe JM (ed) Fructose, High Fructose Corn Syrup, Sucrose and Health

.

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Page 18: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Sugars Production

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Sugars Functionality

• Stability in acid

• Ease of handling

• Flavor enhancement

• Colligative properties

• Fermentable solids

Moisture retention

Resistance to crystallization

Reducing sugars for browning

Sweetness

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Page 20: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Sugars Functionality:Sweetness

SugarsSweetnessIntensity

(crystalline)1

RelativeSweetness(10% ds)2

AbsoluteSweetnes

s(10% ds)3

Fructose 180 117

Sucrose 100 100 100

HFCS-55 99 97

Glucose 74-82 65

1 Schallenberger & Acree. 1971. Sugar Chemistry. AVI Pub. Co., Westport CT.2 White & Parke. 1989. Cereal Foods World. 34(5):392-398.3 Calculated from Schiffman, et al. 2000. Physiology & Behavior. 68:469-481.

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Page 21: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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1970

1971

1972

1973

1974

1975

1976

1977

1978

1979

1980

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

0%

10%

20%

30%

40%

0

50

100

150

200

250

300

350

Calo

ries

per p

erso

n pe

r day

Sugars Availability: HFCS replaced sucrose nearly 1:1

HFCS

Sucrose

21 Data: USDA Economic Research Service (U.S. per capita loss-adjusted food availability: “Total Calories”).

Page 22: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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1970

1971

1972

1973

1974

1975

1976

1977

1978

1979

1980

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

0%

10%

20%

30%

40%

50%

0

50

100

150

200

250

300

350

Perc

enta

ge o

f pop

ulati

on o

bese

Calo

ries

per p

erso

n pe

r day

Obesity

HFCS

22

Sugars Availability: recent data invalidate HFCS-obesity hypothesis

Data: USDA Economic Research Service (U.S. per capita loss-adjusted food availability: “Total Calories”); Flegal et al, JAMA, 2010; Flegal et al, JAMA, 2012.

2013

Page 23: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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1970

1971

1972

1973

1974

1975

1976

1977

1978

1979

1980

1981

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

0%

10%

20%

30%

40%

50%

-50

50

150

250

350

450

550

Total fructose

Obesity

Total added sugars

Obe

sity

– P

erce

nt o

f pop

ulati

on

Calo

ries

per p

erso

n pe

r day

Data: USDA Economic Research Service (U.S. per capita loss-adjusted food availability: “Total Calories”); Flegal et al, JAMA, 2010; Flegal et al, JAMA, 2012.

Sugars Availability: added sugars & fructose also in decline since 1999

2013

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Page 24: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Key Learnings

Sugars part of the diet for millennia, though not in amounts now consumed

Only bona fide challengers to cane sugar – beet sugar and HFCS – developed in response to upsets in supply caused by turmoil of war, weather or politics

Similarities in chemical composition drive similarities in functionality and metabolism

Sucrose is the major U.S. and global sweetener Added sugars, HFCS and fructose have declined since 1999 Correlations with obesity were lost 15 years ago

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Page 25: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Thank you

Page 26: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

P. Courtney Gaine, PhD, RD

ILSI North America

State of the Science: Sugars Intake and Health

Page 27: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Metabolism of Sugars

GlucoseP1

G-6-PaseHK/GK

G-6-P

F-6-PFDPas

ePFK

F-1, 6-bis-P

GAP + DAP

Pyruvate Lactate

Fructose Galactose

F-1-P

DAP

+

glyceraldehyde

Gal-1-P

Fructokinase (liver)

Galactokinase (liver)

+UDPG

G-1-P

+UDP-

Galactose

UDPG

Gal-1-P UDPG transferase

UDPGal-UDPG isomerase

Aldolase B

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Page 28: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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Dietary Sugars Recommendations

Hess, et al. The confusing world of dietary sugars: definitions, intakes, food sources and international dietary recommendations. Food & Function, 2012

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Page 29: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Report Year Recommendation

2002

• Added sugars should comprise no more than 25 percent of total calories consumed.

• Observational data show that intakes of certain nutrients were lower when >25% of calories come from added sugar.

2009

• A prudent upper limit of intake is half of the discretionary calorie allowance, which for most American women is no more than 100 calories per day and for most American men is no more than 150 calories per day from added sugars.

2010

• Reduce the intake of calories from solid fats and added sugars. • USDA Food Pattern (2,000 kcals) – no more than 6% or 32 g is

allowed. These patterns are designed to meet nutrient needs within calorie limits.

European Food Safety Authority 2010

• Not quantified; data not sufficient to set a dietary reference value for sugars

2014*

• WHO recommends reduced intake of free sugars throughout the life-course (strong recommendation).

• In both adults and children, WHO recommends that intake of free sugars not exceed 10% of total energy (strong recommendation).

• WHO suggests further reduction to below 5% of total energy (conditional recommendation).

*proposed 29

Page 30: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

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1999-2000

2001-2002

2003-2004

2005-2006

2007-20080

5

10

15

20

25

18.117.1

15.914.5 14.6

U.S. Trends in Added Sugars Intake (%en)

IOM DRI

WHO Current

WHO Proposed

AHA

Welsh et al. Amer J Clin Nut, 2012

P < 0.001

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Page 31: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Caloric Sweeteners – U.S. Availability Data

1966

1969

1972

1975

1978

1981

1984

1987

1990

1993

1996

1999

2002

2005

2008

2011

100

110

120

130

140

150

160Po

un

ds

pe

r C

ap

ita

http://www.ers.usda.gov/datafiles/Sugar_and_Sweeteners_Yearbook_Tables/US_Consumption_of_Caloric_Sweeteners_/table50.xls (accessed 02 June 2014)

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Percentage Contribution of Various Foods to Added Sugars Intake (2005-2006)

35.7

12.9

10.5

6.6

6.1

3.8

3.5

3.5

2.1

1.9

Soda/energy/sports drinks

Grain-based desserts

Fruit drinks

Dairy desserts

Candy

Ready-to-eat cereals

Sugars/honey

Tea

Yeast breads

Syrups/toppings

http://www.appliedresearch.cancer.gov/diet/foodsources/added_sugars/table5a.html (accessed 03 June 2014)32

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Sugars and Health – The Evidence

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Page 34: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Tweeting? Don’t forget to include our hashtag: #IFTVuilleumier S.. Am J Clin Nutr 1993;58(suppl):733S–6S.

Flegal KM, et al. JAMA 2002;288:1723–7.

Bray GA, et a. Am J Clin Nutr. 2004 Apr;79(4):537-43

Ecological relationship between fructose intake and prevalence of Overweight/Obesity:1961-2000

George Bray

2004

Overweight

Obesity

Total fructose

Free fructose

HCFS

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Calories Have Increased for Most Categories

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http://www.sign.ac.uk/guidelines/fulltext/50/annexb.htmlhttp://www.cnpp.usda.gov/Publications/NutritionInsights/Insight38.pdfhttp://www.nice.org.uk/niceMedia/pdf/GDM_Chapter7_0305.pdf

Hierarchy of evidence in evidence based medicine

Systematic review/

meta-analysis RCTs

RCT

Systematic review/meta-analysis NRCTs

Non-randomized controlled trial (NRCT)

Systematic review/meta-analysis cohort/case-control studies

cohort study/case-control study

Cross-sectional study

Case series/time series

Expert opinion

Decreasing bias

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Evidence-Based Evaluation

“Over time, the process of evaluating the totality of evidence has become more rigorous and, in recent years, more transparent. The principles of evidence-based medicine (EBM) have been adopted, in which a hierarchical approach to the evaluation of evidence is applied, with meta-analyses, systematic reviews, and randomized controlled trials (RCTs) considered the strongest types of evidence.” Maki 2014

Examples:– 2009 FDA EBR System for Health Claim Evaluation– 2005-present – Dietary Guidelines Nutrition Evidence Library

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Page 38: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

TM

Fructose & NAFLD Systematic Review

Sugars & Health Future Research

Needs Assessment

Evidence Map: Sugars & Health

Design Necessary Definitive Trials

Encourage Funding of

Trials

Fund a trial??

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Background: Concerns have been raised about the concurrent temporal trend between simple sugar intakes, especially fructose or HFCS, and rates of nonalcoholic fatty liver disease (NAFLD) in the United States.

Objective: To examine the effect of different levels and forms of dietary fructose on the incidence or prevalence of NAFLD and on indices of liver health in humans.

Fructose, high fructose corn syrup, sucrose, and nonalcoholic fatty liver disease or indices of liver health: A

systematic review

Chung et al., AJCN in press, 2014

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Conclusions Based on indirect comparisons across study findings, the

apparent association between indices of liver health (i.e., liver fat, hepatic DNL, ALT, AST, and GGT) and fructose or sucrose intake appear to be confounded by excessive energy intake.

Overall, the available evidence is not sufficiently robust

to draw conclusions regarding the effects of fructose, HFCS, or sucrose consumption on NAFLD.

Chung et al., AJCN in press, 2014

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Page 41: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

TM

Fructose & NAFLD Systematic Review

Sugars & Health Future Research

Needs Assessment

Evidence Map: Sugars & Health

Design Necessary Definitive Trials

Encourage Funding of

Trials

Fund a trial??

41

Page 42: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Future Research Needs ObjectivesEvaluate the current body of published literature and determine what is and isn’t known (research gaps) regarding the effects of sugar intake on health*

Identify methodological strengths and limitations of previous studies to inform future research designs.

Elaborate and consolidate research gaps and transform the research gaps into research needs**, through an iterative process with stakeholders.

Facilitate the prioritization of research gaps by stakeholders.

Develop and propose recommendations on the key elements to be included in future study designs.

*Scopes are defined by literature search strategy, as well as input from ILSI and stakeholders

**Research needs: The top tier of prioritized research gaps identified through stakeholder engagement.

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Diverse and balancedstakeholder panel

FRN Sugars and Health Stakeholder

Panel

Health Provider

Lay Audience

Research Funder

Policy Maker

Evidence-based MethodologistResearcher

(Intervention)

Researcher (Epidemiology)

Researcher (Statistics)

Product Maker (non-voting)

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Page 44: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

TM

Fructose & NAFLD Systematic Review

Sugars & Health Future Research

Needs Assessment

Evidence Map: Sugars & Health

Design Necessary Definitive Trials

Encourage Funding of

Trials

Fund a trial??

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Page 45: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Email Webinar

Survey Monke

y

In-person Meeting

Building Evidence Map Step 1

Building Evidence Map Step 2

Identifying

Evidence Gaps

Prioritizing

Research Topics

Refine Eligibility Criteria

Refine

Research Questions

Rank Outcome

Importance

Participate in

Manuscript Writing

Literature

Search

Stakeholders’ Role

FRN Assessment: Stakeholder Engagement

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PRISMA Flowchart

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Number of Studies Published per Year (n=213)

Page 48: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

N (%)

Design Randomized (Parallel) Randomized (x-over) Non-randomized Single-arm Undefined trial

47 (23%)95 (47%)25 (12%)25 (12%)10 (5%)

Study Length Acute (<1 day) Chronic (1 day)

72 (36%)123(61%)

Chronic Study Duration 1-14 days 15-30 days 30-60 days 60-90 days 90-120 days +120 days

54 (44%)21 (17%)20 (16%)8 (7%)10 (8%)10 (8%)

Intervention Study Characteristics

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Major Outcome Groups Decided by the Stakeholders

Type II Diabetes Glycemic profile

Glucose tolerance tests

Pre-diabetes

Cardiovascular Disease

Plasma Lipoproteins

Blood Pressure

Cerebrovascular disease

Peripheral Vascular Disease

Body Composition

Fatness

Adipokines

Body Weight BMI

Body Weight

Energy Intake

Energy Expenditure

Mortality All causes

Disease-specific causes

Appetite Appetite

Hunger/Satiety

Diet Quality Nutrient intake

Liver Health Liver enzymes

Liver fat

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148 Trials80 Randomized controlled trials (crossover)28 Randomized controlled trials (parallel) 9 Non-randomized Controlled trials21 Single-arm trials10 Other types of trials

3 CohortsSan Luis ValleyWomen’s Health StudyThe Melbourne Collaborative Cohort Study

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Outcomes # of Studies

Weight 44BMI 12Energy expenditure 8

Carbohydrate oxidation 7Respiratory quotient 3Height 2

52 Trials 18 Randomized controlled trials (crossover)

21 Randomized controlled trials (parallel) 3 Non-randomized Controlled trials

6 Single-arm trials 4 Other types of trials

0 Cohorts

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Outcomes # of Studies

Energy intake 27Fat intake 15Carbohydrate intake 14Protein intake 14Fructose intake 8Fiber intake 5Sucrose intake 5Complex carbohydrate intake 2

Food intake 2Sodium intake 2Added sugar intake 1Calcium intake 1Folate intake 1Glucose intake 1Monounsaturated fat intake 1Polyunsaturated fat intake 1Polyunsaturated/saturated ratio 1

Riboflavin intake 1Saturated fat intake 1Starch intake 1Total 104

32 Trials10 Randomized controlled trials (crossover)12 Randomized controlled trials (parallel) 2 Non-randomized Controlled trials 4 Single-arm trials 4 Other types of trials

0 Cohorts54

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Outcome # of studies

Triglycerides 109Total cholesterol 66LDL 53HDL 49Diastolic BP 17Systolic BP 16VLDL 11Blood pressure 8Cardiovascular Disease 4Lipids 3Oxidized LDL 3Pre beta lipoprotein 3

109 Trials48 Randomized controlled trials (crossover)24 Randomized controlled trials (parallel)18 Non-randomized Controlled trials3 Non-controlled trials12 Single-arm trials4 Other types of trials

4 CohortsPuerto Rico Heart Health ProgramCopenhagen Male StudyNurses’ Health Study 1, Nurses’ Health Study 2, Health Professionals Follow-up Study

European Prospective Investigation into Cancer and Nutrition

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Outcomes # of studies

Satiety 15Ghrelin 8Leptin 8Hunger 5Appetite score 2Caloric compensation 1Prospective consumption 1PYY 1Saliva flow 1Taste 1Total 43

32 Trials15 Randomized controlled trials (crossover) 9 Randomized controlled trials (parallel) 5 Non-randomized Controlled trials 1 Single-arm trials 2 Other types of trials

0 Cohorts

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Outcome # of studies

ALT 8AST 5bilirubin 1DNL 3

GGT 1glutamic oxaloacetic transaminase

2

IHCL 2

liver fat/ectopic lipids 3

Total 26

15 Trials 6 Randomized controlled trials (crossover) 5 Randomized controlled trials (parallel) 1 Non-randomized Controlled trials 1 Single-arm trials 1 Other types of trials

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Page 58: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Top 5 FRN Research Needs IdentifiedAverage

score Group Research Questions

4.20body weight /composition

What is the long-term effect of a reduction in sugars intake on body weight and/or fatness in overweight/obese adults or in children?

4.03body weight /composition

Do dietary sugars impact body fat deposition differently than other energy yielding nutrients?

3.95 Appetite /addiction

What is the effect of sugars intake on satiety and hunger mechanisms? Does sugars intake affect leptin and ghrelin levels, appetite, or fullness? Is there a difference in satiety and appetite between different types of sugar (fructose, sucrose, HFCS, added sugar vs. intrinsic)?

3.83 Diet quality & body weight

Does food source (i.e., food vs. beverage) modify the effect of sugars intake on total caloric intake, and body weight and body composition?

3.69 Appetite /addiction

What are mechanistic pathways in the brain linking sugars consumption to a reward system/insulin and glycemic levels (“addictive behavior” or "sugar addiction)? Does taste play a role in the process?

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Summary

Government and health organizations’ global recommendations for sugars vary significantly and are often derived from differing methodologies and evidence.

– Rationales range from nutrient displacement, to effects on body weight and other chronic diseases.

Sugars intake in the U.S. has decreased over the past 10-15 years.

However, current intakes are still far off of recommendations of sugars intake no greater than 5% of calories.

59

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Summary

Evidence mapping is a tool that is useful for describing the quantity, design, and characteristics of research of a broad field of study. Such a depiction helps to identify research gaps.

The Future Research Needs Assessment is a methodology that engages stakeholders to prioritize research gaps in a field, with the hope that research dollars are diverted toward those questions of greatest public health significance.

With regard to sugars and health, several research gaps remain.

60

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Take Home Messages

When stringent evidence-based methodology is used, there are not enough data to determine an upper level, or recommended level, for sugars intake.

More data from clinical trials are needed before true evidence-based policy and recommendations are made.

Funding of research at realistic levels of intake is critical to understanding the effects of sugars on health.

61

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Future Directions

Fructose & NAFLD

Systematic Review

Sugars & Health Future Research

Needs Assessment

Evidence Map: Sugars & Health

Design Necessary

Definitive Trials

Encourage Funding of

Trials

Fund a trial??

62

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Thank you

Page 64: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Implications of Dietary Guidelines and Public Policy

Roger Clemens, DrPH, CFS, CNS, FIFT, FACN, FIAFSTChief Scientific Officer, [email protected] Professor, Pharmacology & Pharmaceutical Sciences,

USC School of [email protected]

USC Health Center Pharmacy

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Dietary Guidelines for AmericansHistory 1980 – 2010

1980

1985

1990

1995

2000

2005

2010

U.S. Department of AgricultureCenter for Nutrition Policy and Promotion

65

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Quality

Strength of Evidence

Grade I

Good/ Strong

Grade II

Fair

Grade III

Limited/Weak

Grade IV

ExpertOpinion

Grade V

Not Assignable

Scientific rigor/validity

Considers design and execution

Studies of strong design for question

Free from design flaws, bias and execution problems

Studies of strong design for question

With minor methodological concerns,

OR

Only studies of weaker design for question

Studies of weak design for answering question,

OR

Inconclusive findings due to design flaws, bias or execution problems

No research studies available;

Based on usual practice, expert consensus, clinical experience, opinion, or extrapolation from basic research

No evidence that pertains to question being addressed

66

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Consistency

Strength of Evidence

Grade I

Good/ Strong

Grade II

Fair

Grade III

Limited/Weak

Grade IV

ExpertOpinion

Grade V

Not Assignable

Consistencyof findings across studies

Findings generally consistent in direction and size of effect or degree of association, and statistical significance with minor exceptions at most

Inconsistency among results of studies with strong design, ORConsistency with minor exceptions across studies of weaker design

Unexplained inconsistency among results from different studies OR single study unconfirmed by other studies

Conclusion supported solely by statements of informed nutrition or medical commentators

NA

67

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Quantity

Strength of Evidence

Grade I

Good/ Strong

Grade II

Fair

Grade III

Limited/Weak

Grade IV

ExpertOpinion

Grade V

Not Assignable

Number of studies

Number of subjects in studies

One to several good quality studies Large number of subjects studiedStudies with negative results have sufficiently large sample size for adequate statistical power

Several studies by independent investigatorsDoubts about adequacy of sample size to avoid Type I and Type II error

Limited number of studiesLow number of subjects studied and/orinadequate sample size within studies

Unsubstantiated by published research studies

Relevant studies have not been done

68

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Clinical Impact

Strength of Evidence

Grade I

Good/ Strong

Grade II

Fair

Grade III

Limited/Weak

Grade IV

ExpertOpinion

Grade V

Not Assignable

Importance of studied outcomes

Magnitude of effect

Studied outcome relates directly to the questionSize of effect is clinically meaningfulSignificant (statistical) difference is large

Some doubt about the statistical or clinical significance of the effect

Studied outcome is an intermediate outcome or surrogate for the true outcome of interest

OR

Size of effect is small or lacks statistical and/or clinical significance

Objective data unavailable

Indicates area for future research

69

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Strength of Evidence

Grade I

Good/ Strong

Grade II

Fair

Grade III

Limited/Weak

Grade IV

ExpertOpinion

Grade V

Not Assignable

GeneralizableTo population of interest

Studied population, intervention and outcomes are free from serious doubts about generalizability

Minor doubts about generalizability

Serious doubts about generaliz-ability due tonarrow or different study population, intervention or outcomes studied

Generaliz-ability limited to scope of experience

NA

2010 Dietary Guidelines

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2010 Dietary Guidelines

In adults, what are the associations between intake of sugar-sweetened beverages and energy intake and body weight?

– Limited evidence shows that intake of SSB in linked to higher energy intake in adults.

– Moderate body of epidemiologic evidence suggest that greater consumption of SSB is associated with increased body weight in adults.

– Moderate body of evidence suggests that under isocaloric controlled conditions, added sugars, including SSB, are no more likely to cause weight gain than any other source of energy.

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The Concerns

Overnutrition– Energy change dietary patterns and physical activity (lifestyle,

behavior)

– Sodium 1,500 mg/d (at-risk populations)

– Saturated Fatty < 10% total energy (replace with MUFA and

PUFA)

– Added sugars, refined grains contribute excess energy

72

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The Concerns

– Undernutrition

• Shortfall Nutrients

– Vitamins A, C, D, E and K, plus choline, calcium,

magnesium, potassium and dietary fiber

• Public Health Concern

– Vitamin D – many children and majority of adults not

meet AI consume vitamin D-rich foods

– Calcium – many children and majority of adults not meet AI (not

systematic review due to IOM panel)

– Potassium – 3-6% adults meet AI (women & men, respectively)

– Dietary Fiber - < 3% exceed AI

• Selected Population Subgroups

– Folic acid – Adolescent females and women of reproductive capacity

– Iron – Adolescent females and women of reproductive capacity

– Vitamin B12 – Persons over age 50 years73

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2010 Dietary Guidelines Reduce intake of sugar-sweetened beverages:

– Drinking fewer sugar-sweetened beverages and/or consuming smaller portions.

– Strong evidence shows that children and adolescents who consume more sugar-sweetened beverages have higher body weight compared to those who drink less.

– Moderate evidence also supports this relationship in adults.

– SSB provide excess calories and few essential nutrients to the diet and should only be consumed when nutrient needs have been met and without exceeding daily calorie limits.

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Page 75: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

2105 Dietary Guidelines for Americans Update

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http://www.who.int/nutrition/sugars_public_consultation/en/

• The issue: “free sugars” contribute to untoward health effects– Dental caries– Maintain or reduce body weight

• Free sugars– monosaccharides and disaccharides added to

foods by the manufacturer, cook or consumer, and sugars naturally present in honey, syrups, fruit juices and fruit concentrates.

Sugars: The New Dominant Public Health Issue

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http://www.who.int/nutrition/sugars_public_consultation/en/

• Recommendations – Reduce intake of free sugars throughout the life-

course (strong recommendation1).– Intake of free sugars not exceed 10% of total

energy2 (strong recommendation).– Intake of free sugars reduce to below 5% of total

energy (conditional recommendation3).

Sugars: The New Dominant Public Health Issue

77

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http://www.who.int/nutrition/sugars_public_consultation/en/

• Foundational Manuscripts:– Moynihan & Kelly. Effect of caries on restricting

sugars intake. Systematic review to inform WHO guidelines. J Dent Res 2014;93:1:8-18

• There is evidence of moderate quality showing that caries is lower when free-sugars intake is < 10%en.

• With the < 5%en cutoff, a significant relationship was observed, but the evidence was judged to be of very low quality.

Sugars: The New Dominant Public Health Issue

78

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http://www.who.int/nutrition/sugars_public_consultation/en/

Sugars: The New Dominant Public Health Issue• Foundational Manuscripts:

– Te Morenga et al., Dietary sugars and body weight: systematic

review and meta-analysis of randomized controlled trials and

cohort studies. BMJ 2013;346:e7492

• Isoenergetic exchange of dietary sugars with other carbohydrates

showed no change in body weight (0.04 kg, −0.04 to 0.13).

• Hypercaloric ad libitum diets increased sugars intake was

associated with a comparable weight increase

(0.75 kg, 0.30 to 1.19; P=0.001).

• Hypocaloric ad libitum diets reduced intake of

dietary sugars was associated with a decrease

in body weight (0.80 kg, 95% confidence

interval 0.39 to 1.21; P<0.001);79

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Isoenergetic exchange of free sugars with other macronutrients does not affect body weight: WHO-commissioned systematic review and meta-analysis of 13 RCTs (n=144)

Te M

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80

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Te M

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2;3

45

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Addition of excess energy from sugars increases weight in adults: WHO commissioned systematic review and meta-analysis of 30 RCTs

81

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Te M

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201

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7492

Reduction in energy from sugar reduces excess body fatness in adults but not children: WHO commissioned systematic review and meta-analysis of 30 RCTs

Adults

Children

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Page 83: Regulating Sugar: Existing Policies, Trends, and Scientific Justification

Tweeting? Don’t forget to include our hashtag: #IFThttp://www.sign.ac.uk/guidelines/fulltext/50/annexb.html http://www.cnpp.usda.gov/Publications/NutritionInsights/Insight38.pdf http://www.nice.org.uk/niceMedia/pdf/GDM_Chapter7_0305.pdf

Systematic review/

meta-analysis RCTs

RCT

Systematic review/meta-analysis NRCTs

Non-randomized controlled trial (NRCT)

Systematic review/meta-analysis cohort/case-control studies

cohort study/case-control study

Cross-sectional study

Case series/time series

Expert opinion

Decreasing bias

Hierarchy of Evidence

83

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Sugar in ResearchY

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Conclusions:• Increased calories … from added sugar … associated with increased risk of CVD mortality• Consumption of SSB (aka sugar) is associated with elevated CVD mortality

Recommendation:• Limit intake of calories … from added sugar

Headlines: Drink just one 12-ounce

can of sugary soda every day, and you

might be unwittingly increasing your risk of dying from heart disease, suggests

a new study.

84

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Virtual Supermarket RCT

SSB (litre) Light (diet), Bottled Water (litre)

Dairy Drinks(litre)

Coffee/tea(# of items)

AlcoholicDrinks

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Control Taxation

Beve

rage

Pur

chas

es(m

ean

SD

)

Waterlander et al., Appetite 2014;78C:32-9

P=0.09 P=0.67P=0.63P=0.26 P=0.08

Background: Dutch increased VAT from 6% to 19% Study: 102 participants randomized to one of two study groups.

~28% reduction

85

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Unintended Consequences

Chocolate MilkAvailable

Chocolate MilkNot Available

0

50

100

150

200

250

300

350

296.3

267.1

190.4

0

105.9

216.3

0

50.8

Total Milk Purchased

Chocolate MilkPurchased

1% White MilkPurchased

Skim MilkPurchased

Aver

age

Num

ber o

f 8 fl

oz U

nits

So

ld P

er D

ay

Hanks et al., PLOS One 2014;9:e91022

• 68.3% of milk available in schools is flavored

• 61.6% of flavored milk is chocolate• Study from 11

Oregon elementary

schools in the National School Lunch Program

• Chocolate milk remove total decline in milk

sales, 6.8% decrease in

NSLP participation,

increase in food waste

~10%

86

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The Evidence

“…isoenergetic exchange of sugars with other carbohydrates was not associated with weight change.”

Te Morenga et al., BMJ 2012;345:e7492 doi: 10.1136/bmj.e7492

“…observational studies suggest a possible relationship between consumption of SSB and body weight, [however] there is currently insufficient supporting evident from RCTs of sufficient size and duration…”

van Baak and Astrup, Obesity Rev 2009;10(suppl 1):9-23

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What’s Driving Policy?

…strongest evidence for public health and health outcomes is from RCTs; [there] should be cautionwhen communicating recommendations when clinicalevidence or dietary intervention data are not available.

Maki et al., Adv Nutr 2014;5(1):7-15

“epidemiological studies [and statistical modeling from NHANES III] suggest higher intake of added sugar (>10%en) is associated with increased risk for CVD mortality.

Yang et al., JAMA Intern Med 2014; doi: 0.1001/jamainternmed.2013.13563

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Comprehensive Review

Evidence-based resource Written by an international

group of expert authors Up-to-date and

comprehensive resource

2014, XXXI, 379 p, 57 illus, 33 illus in color

89

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International Guidelines and Policies

• Approximately 60 countries recommend limit intake of added sugar

• Recommendations vary: qualitative, quantitative (energy based)

• Primary focus varies: dental caries, CVD, obesity promote healthful lifestyles– Culturally appropriate foods– Sanitation– Clean water

90

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Taxation on SSB

Public health initiative– Effort to reduce obesity and promote weight loss– Effort to decrease financial healthcare burden (1¢/oz $150

MM)

Consumer assessment– Lack political trust (58%)– Oppose intervention (52.5%)– Opinion financial impact on poor (51.2%)– Upset local economy (48.9%)

Jou & Techakehakij. Health Policy 2012;107:83-90Andreyeva et al., Prev Med 2011;52:413-6Barry et al., Am J Prev Med 2013;44:158-63Kotakorpi K. Econ Lett 2008;98:95-9

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Warning Labels

A California bill to require sugary soft drinks to carry labels warning of obesity, diabetes and tooth decay (Bill Monning, D; Central Coast)

Labeling them instead would educate consumers about the dangers of consuming too much sugar without requiring a controversial measure like a tax

Proposed legislation now moves to senate appropriations committee

http://www.reuters.com/article/2014/04/09/us-usa-sodas-california-idUSBREA3824Q20140409Posted April 9, 2014; Accessed April 21, 2014

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Press Release Spin

Spin identified in 40% in scientific article abstract conclusions, and 47% press releases.

RCT-based press releases were overestimated for 27% of reports About 51% combined spin in article conclusions and news releases

Yavchitz A, Boutron I, Bafeta A, Marroun I, Charles aP, et al. (2012) Misrepresentation of Randomized Controlled Trials in Press Releases and News Coverage: A Cohort Study. PLoS Med 9(9): e1001308. doi:10.1371/journal.pmed.1001308

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Medical Reporting Bias?

Newspaper coverage more likely to be observational vs RCT (75% vs 47%, p<0.001) regardless of number of subjects or study length

Observational studies used smaller sample sizes, and more likely to be cross-sectional (71% vs 31%; p<0.001)m while no differences were observed for RCTs.

Selvaraj S, Borkar DS, Prasad V (2014) Media Coverage of Medical Journals: Do the Best Articles Make the News? PLoS ONE 9(1): e85355. doi:10.1371/journal.pone.0085355

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Conclusions

The prevalence of obesity is a global public health burden

No clinical study on SSB and obesity/BMI The global efforts to reduce the prevalence obesity and

overweight include approaches in dietary guidelines, taxation on sugar-sweetened beverages (SSB), and restricted access to these products

Statutory efforts directed to SSB have produced inconsistent results relative to changes in BMI and obesity in targeted populations

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From one peak to another challenge.

Let’s make it happen.

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Thank you for attending.

Questions?