Show Me the Evidence! Busting the Top Three Myths about Aspartame
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1 Show Me the Evidence! Busting the Top Three Myths about Aspartame Supported by: Ajinomoto North America Inc. 1
2 MYTH # 1 MYTH: Low calorie sweeteners, such as aspartame, cause weight gain. FACT: Trial after trial consistently demonstrates that substituting aspartame and other low cal sweeteners for caloric sweeteners are associated with modest weight loss. Examples of supporting data refuting Myth 1: HUMAN CLINICAL TRIALS -- Modest weight loss with substitution of diet products/beverages Blackburn et al, AJCN, 1997! Landmark study (RCT), n=163 obese women (Harvard Med. School)! Randomly assigned to consume vs. abstain from aspartame! Research question: Does the addition of aspartame to a multidisciplinary weight-control program improve weight loss and long-term control of body weight? Aspartame group lost significantly more weight overall and regained significantly less weight during maintenance [1-yr] and follow-up [2-yrs] than non-aspartame group. These data suggest that participation in a multidisciplinary weight-control program that includes aspartame may facilitate the long-term maintenance of reduced body weight. Peters et al, Obesity, 2014! 12-week Prospective Study, (RCT); two sites (N=303) (Univ. CO, Temple Univ.)! Comparison of water vs. NNS beverages (including aspartame) on weight loss! Diet Beverage group 13 lbs! Water group 9 lbs These results strongly suggest that NNS beverages can be part of an effective weight loss strategy and individuals who desire to consume them should not be discouraged from doing so because of concerns that they will undermine short-term weight loss efforts. Tate et al. AJCN, 2012 ( CHOICE RCT)! 6 month, n= 318 (UNC/Chapel Hill)! Research question: Will substituting diet beverages or water for caloric beverages aid in weight loss comparable to a basic weight loss support program? (LCS not defined)! Answer: Yes! Average weight losses: Counseling (AC) group lost ~1.75% bw Water (WA) substitution group -- lost ~2% bw Diet beverage (DB) substitution lost ~2.5% bw! Water or diet beverage group doubled their odds of achieving a 5% weight loss. Preference for sweet foods/beverages did NOT increase. This strategy could have public health significance and is a simple, straightforward message. de Ruyter et al, NEJM, 2012! 18-month Double-Blind, Placebo Control, (RCT) (Univ. Amsterdam)! (n=641, normal weight children, 4.8 years 11.9 years of age)! Replaced sugar-containing beverages w/ LCS beverages (including sucralose + Ace K)! BMI, body weight, skin-fold thickness, waist-to-hip ratio, and fat mass increased significantly less in the sugar-free group. Masked replacement of sugar-containing beverages with non-caloric beverages reduced weight gain and fat accumulation in normal-weight children. 2
3 Ebbeling et al, NEJM, 2012! One-year intervention (RCT) to assess the effect on weight gain by overweight and obese adolescents (Multi-center, Boston)! Substituted non-caloric beverages and reduce consumption of sugar-sweetened beverages (LCS not specified).! Smaller increase in BMI and greater decrease body weight at 1 year intervention with substitution of water or diet beverage.! Effect was neutral at year 2 (1 year post intervention) Replacement of sugar-sweetened beverages with non-caloric beverages did not improve body weight over a 2-year period, but group differences in dietary quality and body weight were observed at the end of the 1-year intervention period. LITERATURE REVIEWS Body of human trials confirm potential benefit Question statement (Grade 1) Findings Zheng et al, JAND 2015 Systematic review of prospective cohort and RCT s examining effects of substituting beverage alternatives for SSBs on long-term health outcomes in children and adults. The overall consensus of our review was that SSB substitution with beverage alternatives such as water and low-calorie beverages may have beneficial effects on long-term body weight management. Academy of Nutrition and Dietetics EAL 2009; Reiterated JAND Position Paper 2012 In adults, does using foods or beverages with aspartame in an energy restricted or ad libitum diet affect energy balance (weight)? Use of aspartame and aspartame-sweetened products as part of a comprehensive weight loss or maintenance program by individuals may be associated with greater weight loss and may assist individuals with weight maintenance over time. Miller & Perez, AJCN, 2014 Meta-analysis of 15 RCT and 9 prospective cohort studies examined the relation between low-calorie sweeteners (from foods, beverages, or table top sweeteners) and body weight and composition.! In RCTs, LCS modestly, but significantly reduced all outcomes examined, including body weight, BMI, fat mass and waist circumference.! Observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI. Data from RCT s, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss, and may be a useful dietary tool to improve compliance with weight loss or weight maintenance plans. Mattes and Popkin, AJCN, 2009 Comprehensive review on appetite, food intake and related mechanisms. (224 research studies referenced)! Nonnutritive sweeteners were not found to heighten appetite when ingested in conjunction with other energy sources.! Addition of NNS to diets poses no benefit for weight loss/ reduced weight gain w/out energy restriction.! Mechanisms by which NNS are purported to promote energy intake and contribute to obesity are not supported by the available evidence.... if nonnutritive sweeteners are used as substitutes for higher-energy-yielding sweeteners, they have the potential to aid in weight management. De la Hunty et al, Brit Nutr J, 2006 Meta-analysis (16 studies) on the effect of aspartame on weight loss, weight maintenance and energy intakes in adults; addresses the question of energy compensation and whether the use of aspartamesweetened foods and drinks is an effective way to lose weight. The meta-analysis demonstrates that using foods and drinks sweetened with aspartame instead of sucrose results in a significant reduction in both energy intakes and bodyweight. This review has shown that using foods and drinks sweetened with aspartame instead of those sweetened with sucrose is an effective way to maintain and lose weight without reducing the palatability of the diet. 3
4 OBSERVATIONAL Mozaffarian et al, NEJM, 2011! Prospective investigations, 3 separate cohorts (n=120,877 women and men free of chronic disease and not obese at baseline): Nurses Health Study ( ) and NHS 11 ( ), Health Professionals Follow-up Study ( )! The relationships between lifestyle factors and weight change were evaluated at 4-year intervals! Large scale epidemiological studies that controlled for reverse causality; showed neutral to beneficial effect of diet soda on body weight. OTHER National Weight Control Registry Our findings suggest that both individual and population-based strategies to help people consume fewer calories may be most effective when particular foods and beverages are targeted for decreased (or increased) consumption. Catenacci et al, Obesity J, 2014! Cross-sectional study to evaluate prevalence of and strategies behind low/no calorie sweetened beverage consumption in successful weight loss maintainers.! Online survey administered to 434 members of the National Weight Control Registry individuals who had lost > 13.6 kg (6 lbs) and maintained weight loss for > 1 year! Regular consumption of low/no calorie sweetened beverages is common in successful weight loss maintainers for various reasons including helping individuals to limit total energy intake. Changing beverage consumption patterns was felt to be very important for weight loss and maintenance by a substantial percentage of successful weight loss maintainers in the National Weight Control Registry. 4
5 Myth #2 MYTH: Low calorie sweeteners, such as aspartame, increase desire for sweets, promote hunger, and decrease satiety. CLAIM: By confusing our taste preferences, leading to altered taste perception and a preference for high- calorie, sweet- tasting foods and beverages. FACT: Studies on humans (as opposed to rats) show that including low calorie sweeteners like aspartame have no impact on satiety and do not increase desire for sweets. Examples of supporting data refuting Myth 2: HUMAN CLINICAL TRIALS CHOICE RCT Piernas et al, AJCN, 2013! 6 month, 3-arm study (RCT), n=318 (UNC/Chapel Hill)! Investigated whether energy intakes and dietary patterns were different in subjects who were randomly assigned to substitute caloric beverages with either water or diet beverages (included aspartame) Findings! The diet beverage group showed decreases in most caloric beverages and specifically reduced more desserts than the water group did. Our study does not provide evidence to suggest that a short-term consumption of diet beverages, compared with water, increases preferences for sweet foods and beverages. LITERATURE REVIEWS Academy of Nutrition and Dietetics EAL 2009, Reaffirmed JAND 2012 Question Grade 1 In adults, does aspartame affect appetite or food intake? There is good evidence that aspartame does not affect appetite or food intake. Bellisle, Curr Obes Rep, 2015 Findings Reviewed specific effects of LCS use on appetite for sweet products; included observational studies, experimental laboratory studies, randomized controlled trials, and brain imaging studies. (38 studies included)! Use of LCS showed no consistent association with a heightened appetite for sugar or sweet products.! In many instances, the use of LCS is associated with a lower intake of sweet tasting substances. Recent intervention studies in children and adults confirm that LCS use tends to reduce rather than increase the intake of sugar-containing foods and facilitate, rather than impair weight loss. 5
6 Myth#3 MYTH: Low calorie sweeteners, such as aspartame, promote Metabolic Syndrome, glucose intolerance, and increased risk of diabetes. FACT: Aspartame has no effect on blood sugar levels, or on risk of Metabolic Syndrome or diabetes. Examples of supporting data refuting Myth 3: Human Clinical Trials Maersk et al, AJCN, 2012! 6-month intervention, (RCT), n=47 overweight subjects (Multi-center, Denmark)! Assigned to 4 different test drinks: regular soda, isocaloric semi-skim milk, aspartamesweetened diet cola, and water! Objective to compare the effects of sugar-sweetened soft drinks (SSSD) with those of isocaloric milk and noncaloric soft drink on changes in total fat mass and ectopic fat deposition (in liver and muscle tissue).! Daily intake of SSDs for 6 months increased ectopic fat accumulation and lipids compared with milk, diet cola, and water.! The effect of diet cola is mainly neutral and very similar to that of water. The suggestions from observational studies that intake of diet cola can result in obesity, type 2 diabetes, and the metabolic syndrome are not supported by the findings of our current intervention, i.e., that the effect of diet cola on fatness, ectopic fat, and metabolic factors is mainly neutral and very similar to that of water. Also, diet cola was found to have effects nearly similar to milk in reducing blood pressure. Bryant et al, Eur J Clin Nutr, 2014! Randomized study design, n=10, healthy, normal weight individuals, mean age 21, studied on 4 separate days (Multi-center, UK and New York)! To determine the effect of a panel of non-nutritive sweeteners: aspartame, saccharin, and acesulfame-k, delivered in doses that would be consumed in normal usage! Given in combination with glucose, assessing effect on glycemic responses and appetite! No additional effect of aspartame or saccharin on the blood glucose response to oral glucose at any time point! Ace-K exerted a small effect! None had an effect on perceptions of huger or fullness We conclude that there is no consistent evidence that non-nutrient sweeteners, when acutely consumed with glucose in dietetically relevant doses, have a class effect in modulating blood glucose in healthy human subjects. However, acesulfame-k may require further exploration. Abdalleh et al, AJCN, 1997! Double-blind placebo randomized trial, n=12 normal weight men (France)! Investigated the effect of oral sensation of sweetness on cephalic-phase insulin release (CPIR) and other indexes associated with glucose metabolism using nutritive and nonnutritive sweetened tablets (aspartame/polydextrose) as stimuli. No change in plasma glucose, insulin or glucagon after aspartame consumption. This study suggested that oral stimulation provided by sweet non-flavored tablets is not sufficient for inducing CPIR. 6
7 LITERATURE REVIEWS Magnuson et al, Crit Rev Tox, 2007 Convene an independent international panel of experts* to review all scientific studies and assess the safety of current consumption of aspartame.! Panel spent 11 months reviewing > 500 scientific articles and reports on aspartame from past 30 years! *Experts: Food toxicology, metabolism, carcinogenesis, pathology, neurotoxicology, epidemiology, toxicology of methanol & formaldehyde The weight of existing evidence is that aspartame is safe at current levels of consumption as a nonnutritive sweetener.... Aspartame does not affect glycemic response in normal or diabetic individuals, and does not affect metabolic control or insulin release. Pereira, Nutrition Reviews, 2013 To provide a synthesis of the literature on the effects of non-nutritive or artificial sweeteners (ASBs) on body weight, cardiovascular disease, and type 2 diabetes. (review of 34 studies)! Prospective observational studies have revealed mixed results, and it appears that reverse causality is a particular problem, since individuals who are at higher risk for weight gain may choose to consume ASBs in an attempt to control their weight or reduce disease risk.! For experimental studies, the evidence currently suggests that obesity risk may be lower when low calorie sweetened beverages replace sugar-sweetened beverages (SSB) in the diet.! It appears that the association between low calorie sweetened beverage intake and type 2 diabetes is likely an artifact of reverse causality. In terms of general public health recommendations or clinical advice, the scientific evidence does not presently support a blanket recommendation to either consume or avoid <low calorie sweetener> consumption in and of itself. However, for individuals who are frequent (several times per week or more) consumers of SSB and are overweight or at risk for weight gain and obesity, it seems reasonable, based on the evidence, to recommend replacing SSBs with either <low calorie sweetened beverages>, water, or other unsweetened low-calorie beverages, such as plain tea or coffee. Renwick & Molinary, Br J Nutr, 2010 To explore the interactions between sweeteners and enteroendocrine cells and consequences for glucose absorption and insulin release. (33 studies reviewed) Data from numerous publications on the effects of low-energy sweeteners on appetite, insulin and glucose levels, food intake and body weight have shown that there is no consistent evidence that low energy sweeteners increase appetite or subsequent food intake, cause insulin release or affect blood pressure in normal subjects. The data from extensive in vivo studies in human subjects show that low-energy sweeteners do not have any of the adverse effects predicted by in vitro, in situ or knockout studies in animals. More about Aspartame Aspartame is a low calorie sweetener that, when used on its own to sweeten foods and drinks, tastes just like sugar. The discovery of aspartame was a breakthrough in low calorie sweeteners because of its likeness to sugar, and because it has no lingering or metallic aftertaste. Taste tests show that the same holds true today: most people prefer the taste of low calorie foods and drinks sweetened with aspartame. Aspartame has been used by millions of consumers in countries around the world for more than 30 years. For more information, visit: aboutaspartame.com, aspartame.net, or aspartame.org. 7
8 More about Aspartame Aspartame is a low calorie sweetener that, when used on its own to sweeten foods and drinks, tastes just like sugar. The discovery of aspartame was a breakthrough in low calorie sweeteners because of its likeness to sugar, and because it has no lingering or metallic aftertaste. Taste tests show that the same holds true today: most people prefer the taste of low calorie foods and drinks sweetened with aspartame. Aspartame has been used by millions of consumers in countries around the world for more than 30 years. For more information, visit: aboutaspartame.com, aspartame.net, or aspartame.org. 8
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