Straight Talk about Low Calorie Sweeteners for People with ... · Achieved mean wt loss: 34.2 +...

Straight Talk about Low Calorie Sweeteners for People with Diabetes

Diabetes SistersJune 15, 2016

Disclosures*

Consultant, Heartland Food Products Group, manufacturer of SPLENDA® Sweetener Products

*Related to this presentation

LCS: Rationale for Use

Replace added sugars

Offer sweet, good tasting lower calorie foods, beverages, sweeteners to satisfy innate desire for sweetness

Added sugars: 270 kcals/day (13% total calories/day) 1

1. Scientific Report of the 2015 Dietary Guidelines Advisory Committee. Part D. Chapter 6: Cross-Cutting Topics of Public Health Importance. http://www.health.gov/dietaryguidelines/2015-scientific-report/11-chapter-6/d6-3.asp

2. Dietary Guidelines for Americans 2015-2020, 8th ed: http://health.gov/dietaryguidelines/2015/guidelines/

Dietary Guidelines: Reduce Added Sugars

Dietary Guidelines 2015-2020: reduce/limit added sugars1,2

Growing evidence health concerns:1

Strong: Risk of overweight/obesity, type 2 diabetes (adults)

Moderate: high blood pressure, stroke, heart disease, high triglycerides

DG Advisory Committee recommendations (2/15):1

Reduce added sugars < 10% of total calories1

Revise Nutrition Facts label:

Include added sugars (total g), % Daily Value2


2. Dietary Guidelines for Americans 2015-2020, 8th ed: http://health.gov/dietaryguidelines/2015/guidelines/3. Changes to the Nutrition Facts Label: (final regulations, published 5/20/16)

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm

Final Regulations for NEW Nutrition Facts Label1,2

1. Changes to the Nutrition Facts Label: (final regulations, published 5/20/16) http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm


When can you expect to see the

new label?2018 - 2019

Topics

• Safety regulations, review

• Benefits: weight control, diet quality

• Practical advice for use

Approval of Low Calorie Sweeteners by U.S. FDA

U.S. FDA regulates, approves ingredients as food additive or Generally Recognized As Safe (GRAS)1,2

Follows established rigorous protocols for safety/safety review2

Standard of safety: “…reasonable certainty of no harm…”

Approved for entire population

1. Rulis, AM, Levitt JA: FDA’s food ingredient approval process. Safety assurance based on scientific assessment. Regulatory Toxicology and Pharmacology. 2009; 53:20-31.

2. Guidance for industry and other stakeholders toxicological principles for the safety assessment of food ingredients see http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodingredientsandpackaging/redbook/default/htm

Major LCS in Use in U.S. Today1

NNS Name Initial Approval/Use+ FDA Approval Route

Saccharin U.S. use in early 1900’s GRAS2

Aspartame 1981 Food additive

Acesulfame-K 1988 Food additive

Sucralose 1998 Food additive

Neotame 2002 Food additive

Stevia extracts 2008 - 2015 GRAS2,3

Monkfruit extract (luo han guo)

2009 GRAS 2,4,5

Allulose (psicose) 2015 GRAS6

1. Academy Nutrition and Dietetics. Use of nutritive and nonnutritive sweeteners (position paper). J Acad Nutr Diet. 2012; 112(5):739-757. 2. GRAS notices are submitted to FDA under its proposed rule of April 17, 1997, published in the Federal Register at 62 FR 18938-18964. 3. What refined Stevia preparations have been evaluated by FDA to be used as a sweetener? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm214865.htm4. GRAS notice no. GRN 000301 (self-affirmation notification to FDA)

http://www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000301.pdf 7/23/20095. FDA. Agency response letter GRAS notice no. GRN 000301.

http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm253511.htm, 4/11/20116. Agency Response Letter GRAS Notice No. GRN 000498 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm406210.htm

+Listed in chronological order of availability in U.S. marketplace.

FDA has found all of these LCS to be safe for their intended and permitted uses.

FDA’s Definition of “Natural”, Changes?

“From a food science perspective, it is difficult to define a food product that is 'natural' because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.1”

Update 5/9/16: “Because of the changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term “natural,” the agency asked the public [11/15] to provide information and comments on the use of this term in the labeling of human food products.”2

1. What is the meaning of ‘Natural’ on the label of food: http://www.fda.gov/aboutfda/transparency/basics/ucm214868.htm2. “Natural” on Food Labeling:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm

Organizations’ Statements Support Safety

American Cancer Society1

Nat’l Cancer Institute2

American Diabetes Association/American Heart Association3

Academy Nutrition & Dietetics4

American Diabetes Association5

American Academy of Pediatrics6

1. American Cancer Society: http://www.cancer.org/healthy/eathealthygetactive/acsguidelinesonnutritionphysicalactivityforcancerprevention/acs-guidelines-on-nutrition-and-physical-activity-for-cancer-prevention-common-questions, last revised 2016

2. National Cancer Institute: http://www.cancer.gov/about-cancer/causes-prevention/risk/myths, last revised 2014 3. Nonnutritive Sweeteners: Current Use and Health Perspectives. Scientific statement from American Diabetes Association (ADA) in Diabetes Care:

http://care.diabetesjournals.org/content/early/2012/07/06/dc12-9002.full.pdf+html) and American Heart Association in Circulation: http://circ.ahajournals.org/content/early/2012/07/09/CIR.0b013e31825c42ee. (Published simultaneously)

4. Academy of Nutrition and Dietetics. Use of nutritive and nonnutritive sweeteners (position paper). J Acad Nutr Diet. 2012; 112(5):739-757.5. Evert A, Boucher J, et al. Nutrition therapy recommendations for the management of adults with diabetes (position statement). Diabetes Care:

2013;36(11):3821-3842.6. American Academy of Pediatrics Policy Statement. Snacks, Sweetened Beverages, Added Sugars, and Schools. Pediatrics. 2015;135(3):575-583.

ADA: Nutrition Therapy for Adults: 20121

“Use of nonnutritive sweeteners (NNSs) has the potential to reduce overall calorie and carbohydrate intake if substituted for caloric sweeteners without compensation by intake of additional calories from other sources.”

Safety: statement refers to the reviews and approvals by FDA.

Glycemic effect: statement concludes research supports that NNS [LCS] do not produce a glycemic effect unless other calorie containing ingredients are in the product.

1. Evert A, Boucher J, et al. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care: 2013;36(11):3821-3842.

Please Don’t Eat the Media Headlines*

Which studies do or don’t YOU hear about?

The third-party trademarks used herein are registered trademarks of their respective owners.

*Slide title adopted from David Katz, MD, MPH, Director of Yale University’s Yale-Griffin Prevention Research Center

Original research, go beyond press releases, spin and media headlines

On new research. Consider within existing body of evidence, government regulatory review, association recommendations and position papers

On the vast body of scientific research, not just one new study

1. Read…

2. Reflect…

3. Rely…

Don’t Eat the Media Headlines: Read, Reflect, Rely

Topics


• Benefits: weight control, diet quality


LCS Use and Weight Control1

Summary: Randomized control studies done in humans consistently show that

simple behavior changes made to control weight can overcome any proposed mechanism that might

promote an increase in calories and weight gain.

1. Peters JC, Beck J: LCS use and energy balance. Physiology & Behavior. 2016. http://dx.doi.org/ 10.1016/j.physbeh.2016.03.024

LCS for Successful Weight Control: NWCR

National Weight Control Registry: largest and longest study observing the experiences of successful wt losers1

Entry: >30 lbs and kept off >1 yr

Random sample (N=434) NWCR participants Achieved mean wt loss: 34.2 + 18.5 kg maintained for 7.8 + 5.2 yrs Responded to online survey about consumption of low/no calorie

beverages

1. Thomas J. Graham, Dale S. Bond, Suzanne Phelan, et al. Weight-loss maintenance for 10 yrs in NWCR. Am J Prev Med. 2014;46(1):17-23.2. Catenacci VA, Pan Z, et al: Low/No Calorie Sweetened Beverage Consumption in National Weight Control Registry. Obesity.

2014;22(10):2244-2251.

Results:

53% regularly consume low-and no-calorie sweetened beverages daily

78% of low- and no-calorie sweetened beverage drinkers say diet beverages help them control total calorie intake

Top 5 reasons:

1. taste (54%)2. thirst (40%)3. part of routine (27%)4. reduce calories (22%)5. go with meals (21%)

LCS and Diet Quality/Healthy Eating

Drewnowski1: 5 cycles NHANES data (1999-2008), diet quality assessed* LCS consumers ate more vegetables, whole grains and low-fat dairy

Piernas2: Secondary analysis of CHOICE, 3 groups (control, water and diet beverage), 6 mos Both study groups (diet beverage, water) reduced total energy, carbohydrates, total sugar,

added sugars and other calorie containing nutrients (protein, fat)

DB: > reduction of desserts compared to water drinkers

Gibson3: Adults in UK National Diet and Nutrition Survey, 4 groups: SSB, LCS-B, non-consumers of soft drinks (NC) and consumers BB LCS-B and NC consumed less calories and sugars than consumers of SSB or BB

NC and LCS-B consumers had higher quality diets compared to SSB and BB consumers

*HEI/Healthy Eating Index was developed by USDA to measure compliance with U.S. dietary recommendations and guidelines.**Solid Fats, Alcoholic Beverages and Added Sugars. 1. Drewnowski A, Rehm CD: Consumption of LCS among U.S. adults Is associated with higher healthy eating index (HEI 2005) scores and more physical

activity. Nutrients. 2014;6:4389-4403. Infographic: http://depts.washington.edu/uwcphn/reports/lcs_infographic.pdf 2. Piernas C, et al. Dietary Consumption Patterns? Results from the Choose Healthy Options Consciously Everyday (CHOICE) Randomized Clinical Trial.

Am J Clin Nutr. 2013;97:604-611. 3. Gibson SA, et al. Low Calorie Beverage Consumption Is Associated with Energy and Nutrient Intakes and Diet Quality in British Adults. Nutrients.

2016; http://www.mdpi.com/2072-6643/8/1/9

Topics

• Trends in use


• Efficacy: metabolic and weight control, diet quality


LCS: Not a Magic Bullet to Achieve Diabetes/Health Goals in the Face of Overeating and/or Unhealthy Eating

LCS: A Tool in Your Toolbox to Ease, Improve Adherence, Potentially Achieve Your Nutrition, Diabetes Goals

Weight Control3

BP Control

Lipid Control3

Glycemic Control

Diet Quality

LCS Use within Healthy Eating Plan1,2,3

1. 2015-2020 Dietary Guidelines: http://health.gov/dietaryguidelines/20152. Fernstrom JD: Nonnutritive Sweeteners and Obesity. Ann Rev Food Sci Technol. 2015;6:119-136.3. Peters JC, Beck J: LCS use and energy balance. Physiology & Behavior. 2016. http://dx.doi.org/ 10.1016/j.physbeh.2016.03.024

“Think Before You Drink”

Reduce added sugars from sugar-sweetened beverages1 (47% of added sugars from beverages2)

Water is the preferred beverage choice1

Drink sparkling water, flavored seltzer, club soda

Flavor water/seltzer with juice, lemon, lime, vegetables, dry powder mix without sugar

Choose diet soda over regular soda

Select other zero calorie beverages made with LCS

Sweeten hot or cold drinks with preferred LCS

Make your own ice tea, fruit punch, drinks with dry powder mix without sugar with preferred LCS

1. Dietary Guidelines for Americans 2015-2020, 8th ed: http://health.gov/dietaryguidelines/2015/guidelines/2. Scientific Report of the 2015 Dietary Guidelines Advisory Committee. Part D. Chapter 6: Cross-Cutting Topics of Public Health Importance.

http://www.health.gov/dietaryguidelines/2015-scientific-report/11-chapter-6/d6-3.asp

Reduce Added Sugars, Satisfy Desire for Sweet Taste/Sweets

Sugar-free means added sugars free, not calorie-free

Review “natural” term

Clarify agave, honey contain calories, raise BG

Product categories: Diet soda/beverages = 0 calories

Tabletop sweeteners = negligible calories*

Sugar-free foods/beverages with calorie-containing ingredients**

Learn to cook and bake with LCS

How to replace LCS, save calories, carbohydrate and NOT compensate (replace calories) from other foods

*Calories from bulking ingredients dextrin, maltodextrin; ADA define free food <20 cal/svg**Glycemic effect: statement concludes research supports that NNS [LCS] do not produce a glycemic effect unless other calorie containing ingredients are in the product.

Straight Talk about Low Calorie Sweeteners for People with Diabetes

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Straight Talk about Low Calorie Sweeteners for People with ... · Achieved mean wt loss: 34.2 +...

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