Below is a list of important clinical studies, evaluating the effects of different low-calorie sweeteners on body weight and other related outcomes. Not surprisingly, FDA-permitted low- and no-calorie sugar substitutes do not cause weight gain. This finding is well-supported by long-term studies in laboratory species. The lack of ability of sucralose to increase body weight is also found when daily intakes are much greater than what could be expected in human use. The findings are not surprising. Most FDA-permitted low-calorie sweeteners, including sucralose, contain zero or negligible calories.
A systematic review, including meta-analyses, of the evidence from human and animal studies
This systematic review by Rogers et al., conducted on behalf of the European branch of the International Life Sciences Institute (ILSI), covers a large and lengthy body of evidence which includes numerous animal studies and several types of human studies including observational prospective cohort studies, short term studies (1 day or less), and sustained intervention studies (1 day or longer). Studies reviewed covered a broad range of non-nutritive sweeteners (NNS) types, NNS approved by the U.S. Food and Drug Administration (FDA) and others that are either not currently available in the U.S. or approved to date. Consistent with other recent systematic reviews of NNS research, this review concludes that use of NNS in place of added sugar can help with decreasing both energy intake and body weight. The data do not support NNS having an ability to increase energy intake. Use of beverages sweetened with NNS in place of beverages with added sugar was also found to generally lead to small decreases in body weight, even when compared to use of water as a means to help lower added sugar intake. The authors noted that this benefit was supported mainly by studies with the most reliable type of study design, i.e., human intervention studies, which offer stronger evidence than observational prospective cohort studies. At the conclusion of this systematic review, the authors suggest that the discussion about NNS shift from efficacy to how they can best be used to help reach public health goals, such as reducing added sugars and calories.View full article Back to top
A randomized controlled trial
The randomized control trial (RCT) by Campos, et al., compared the impact of Artificially Sweetened Beverages (ASB) with Sugar-Sweetened Beverages (SSB) on intrahepatic fat among men and women with a BMI >25 who usually consumed two or more 22-oz. SSB (carbonated soft drinks and sugar-sweetened tea) daily. Study participants were randomly assigned to consume their habitual SSB intake (control group) or replace their habitual SSB intake with ASB for 12 weeks (intervention group) with a 4 week run-in period. Thirty-one subjects began the study and 27 completed it.
Study participants were provided with all beverages. Compliance, which was reported to be 90%, was assessed at bi-weekly follow up visits by a count of returned empty packages. Bi-weekly visits included weight, body composition, blood pressure, metabolic markers and several other measurements completed in a fasting state. At weeks 10 and 16 food intake, physical activity, body composition, and daily urinary fructose and sucrose excretion were measured. At week 16, the conclusion of the study, intrahepatocellular lipid concentrations (IHCL), and visceral adipose tissue volume (VAT) was measured.
Results showed that among participants consuming ASB, total energy, carbohydrate, and sugar intakes were significantly decreased while the subjects continuing to consume SSB showed no differences in intake. These dietary changes were accompanied by a significant, 26% on average, decrease in IHCL. This decrease was greater in the participants with IHCL higher than 60 mmol/l than in subjects with low IHCL. Subjects with IHCL greater than 60 mmol/l also had significantly higher BMI, visceral adipose tissue volume (VAT), triglycerides, uric acid, liver enzymes, lower insulin sensitivity and HDL-cholesterol. There was no significant effect of ASB on body weight, VAT or metabolic markers.View full article Back to top
This research paper by Bellisle analyzes several types of studies including observational, experimental laboratory, randomized controlled trials and brain imaging for specific effects of Low Calorie Sweeteners (LCS) on appetite for and consumption of sweet tasting products. The paper draws several conclusions: 1) there is no consistent relationship demonstrating a heightened appetite for sweet foods among LCS users, 2) some research demonstrates that people who use LCS consume fewer sweets, 3) a growing group of intervention studies in children and adults demonstrate that LCS use within a calorie-controlled eating pattern can help people reduce the intake of caloric sweeteners and support weight loss efforts. Two important caveats about the research are noted: 1) LCS represent a diverse group of products that vary in their chemical origins, composition, metabolism and excretion, 2) a wide variety of research methods are used and studies are conducted on a wide gamut of populations. However, the author notes, research conclusions are largely convergent.View full article Back to top
is associated with higher healthy eating index (HEI) scores and more physical activity
This study, which examined a decade of data collected from over 22,000 people by the National Health and Nutrition Examination Survey (NHANES), suggests that those who consume foods and beverages made with no-, low- and reduced-calorie sweeteners (LCS) have better quality diets and are more likely to be physically active. Statements made in a 24-hour food and activity recall interview were used to identify people who consumed LCS products, including beverages, foods and tabletop sweeteners. Diet quality was assessed using the Healthy Eating Index 2005 (HEI 2005), a tool developed by the U.S. Department of Agriculture (USDA) which looks at individual compliance to dietary recommendations. Physical activity, tobacco and alcohol use were self-reported by the participants.
According to the researchers, the present analysis suggests that LCS consumers may differ in several, previously unobserved ways from non-consumers in terms of their health behaviors. In particular, LCS consumers were more physically active and had higher HEI scores than non-consumers and were less likely to smoke or consume alcohol.View full article Back to top
The aim of this cross-sectional study was to evaluate prevalence of and strategies behind low/no calorie sweetened beverage (LNCSB) consumption in successful weight loss maintainers. An online survey was administered to 434 members of the National Weight Control Registry (NWCR), individuals who have lost more than or equal to 13.6 kg (about 30 pounds) and maintained weight loss for more than 1 year. The results showed that regular consumption of LNCSB 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 NWCR. Moreover, several interventional studies have shown low/no calorie sweeteners can be a useful tool in weight loss and weight loss maintenance programs.Back to top
A meta-analysis of randomized controlled trials and prospective cohort studies
A new meta-analysis of research spanning 35 years finds that replacing sugar with low calorie sweeteners (LCS) results in a modest weight loss and may be a useful dietary tool to improve compliance with weight loss or weight maintenance plans. Importantly, the analysis also shows that low calorie sweeteners do not cause weight gain. Vanessa Perez, Ph.D., and her colleague, Paige E. Miller, Ph.D., M.P.H., conducted a meta-analysis of published studies dating back to 1976. Fifteen randomized controlled trials and nine prospective observational cohort studies were examined. Data from the randomized controlled trials indicate that substituting low calorie sweeteners in place of sugar does not cause weight gain and may be a useful tool in helping people stick to weight loss and weight management strategies. The researchers noted that there have been hypotheses that low calorie sweeteners might cause weight gain for various reasons, such as decreasing satiety, and increasing appetite, hunger, or sweets cravings. The results of the meta-analysis, however, showed, instead, that substituting low-calorie sweeteners for sugar can result in modest weight losses. In turn, this argues against the hypothesis that no-calorie sweeteners increase sweet cravings or appetite to lead to weight gain.View full article Back to top
This study was designed to compare the efficacy of non-nutritive sweetened beverages (NNS) or water for weight loss during a 12-week behavioral weight loss treatment program. An equivalence trial design with water or NNS beverages as the principal factor in a prospective randomized trial among 303 men and women was employed. All participants participated in a behavioral weight loss treatment program. The results of the weight loss phase (12 weeks) of an ongoing trial (1 year) that is also evaluating the effects of these two treatments on weight loss maintenance were reported.
The results showed that the participants who consumed NNS beverages lost significantly more weight compared to the group who consumed water after 12 weeks. The results show that water is not more effective than NNS beverages for weight loss during a comprehensive behavioral weight loss program.View full article Back to top
In the discussion of the study design, the authors note: "The intent of this study was to evaluate whether small changes in diet and physical activity, as promoted by the America on the Move® initiative, could prevent excessive weight gain in overweight children." They conclude that, "The small-changes approach advocated by America on the Move® could be useful for addressing childhood obesity by preventing excess weight gain in families."View full article Back to top
Study abstract: "Replacement of caloric beverages with noncaloric beverages may be a simple strategy for promoting modest weight reduction; however, the effectiveness of this strategy is not known. We compared the replacement of caloric beverages with water or diet beverages (DBs) as a method of weight loss over 6 mo in adults and attention controls (ACs). Overweight and obese adults [n = 318; BMI (in kg/m(2)): 36.3 ± 5.9; 84% female; age (mean ± SD): 42 ± 10.7 y; 54% black] substituted noncaloric beverages (water or DBs) for caloric beverages (=200 kcal/d) or made dietary changes of their choosing (AC) for 6 mo. In an intent-to-treat analysis, a significant reduction in weight and waist circumference and an improvement in systolic blood pressure were observed from 0 to 6 mo. Mean (±SEM) weight losses at 6 mo were -2.5 ± 0.45% in the DB group, -2.03 ± 0.40% in the Water group, and -1.76 ± 0.35% in the AC group; there were no significant differences between groups. The chance of achieving a 5% weight loss at 6 mo was greater in the DB group than in the AC group (OR: 2.29; 95% CI: 1.05, 5.01; P = 0.04). A significant reduction in fasting glucose at 6 mo (P = 0.019) and improved hydration at 3 (P = 0.0017) and 6 (P = 0.049) mo was observed in the Water group relative to the AC group. In a combined analysis, participants assigned to beverage replacement were 2 times as likely to have achieved a 5% weight loss (OR: 2.07; 95% CI: 1.02, 4.22; P = 0.04) than were the AC participants. Replacement of caloric beverages with noncaloric beverages as a weight-loss strategy resulted in average weight losses of 2% to 2.5%. This strategy could have public health significance and is a simple, straightforward message. This trial was registered at clinicaltrials.gov as NCT01017783."Back to top
De la Hunty et al. conducted a meta-analysis of numerous studies investigating weight management with aspartame used as a means to control calorie intake from sugar. Excerpt from the paper: "This report reviews the evidence for the effect of aspartame on weight loss, weight maintenance and energy intakes in adults and addresses the question of how much energy is compensated for and whether the use of aspartame-sweetened foods and drinks is an effective way to lose weight...The meta-analyses [conducted] demonstrate that using foods and drinks sweetened with aspartame instead of sucrose results in a significant reduction in both energy intakes and bodyweight."Back to top
From the study abstract: "Aspartame has not been found to increase food intake; indeed, both short-term and long-term studies have shown that consumption of aspartame-sweetened foods or drinks is associated with either no change or reduction in food intake." Preliminary clinical trials suggest that aspartame may be a useful aid in a complete diet and exercise program or in weight maintenance. Intense low-calorie sweeteners have never been found to cause weight gain in humans.Back to top
Mattes and Popkin reported their findings following a review of available literature on low-calorie sweetener use and utility in weight management strategies. Their review describes recent trends in the use of non-nutritive sweeteners and current knowledge of their effects on short-term appetite and food intake as well as longer-term energy balance and body weight. The authors report that the evidence suggests that, when non-nutritive sweeteners are used as substitutes for higher energy yielding sweeteners, they have the potential to aid in weight management. They also report that, with respect to energy intake, there is no substantive evidence that inherent liking for sweetness or non-nutritive sweetener– activation of reward systems is problematic.Back to top
Research supports the role of no-calorie sweeteners in weight management. Sugar added to foods and beverages provides calories, but no additional nutrients, and so calories from sugar are often referred to as "empty calories." SPLENDA® Brand Sweetener can help decrease the empty calories consumed from using sugar. Together with a plan for healthy physical activity, no calorie sweeteners can help with managing body weight.
While it has been suggested by some that no calorie sweeteners may cause weight gain, these claims are not backed by the collective scientific data. Often these claims are typically based on studies that were not designed to understand actual effects on weight management or the studies were of a very short duration, involving only a small numbers of animals. This includes, for example, a recent study in male rats funded by the Sugar Association that was found subsequently by recognized experts in nutrition and public health to have serious design flaws and conclusions that are unreliable and unsupported by the study data. The Expert Panel that investigated this study published their findings in the journal, Regulatory Toxicology and Pharmacology. They concluded that the results of the study in question cannot be viewed as evidence that either SPLENDA® No Calorie Sweetener or sucralose cause any adverse effects.
In contrast, studies in people for up to 3 years support that no calorie sweeteners can be useful in weight management strategies. Additionally, rigorous, large studies in rats that received sucralose at doses equal in sweetness to over 40 pounds of sugar per day over a lifetime showed that sucralose does not cause increases in body weight. There are a lot of data that support that sucralose and other no-calorie sweeteners can be a useful in strategies for weight management.
A 2007 study published in Pediatrics®, the official journal of the American Academy of Pediatrics, demonstrated that by making 2 simple changes daily - using SPLENDA® Brand Sweetener as part of a program to reduce calorie intake and increasing activity levels - families can help overweight children slow their rate of weight gain.
A recent article in The New York Times (J. Brody, February 17, 2009) points out that when used properly, no-calorie sweeteners can aid in weight management. The article states, "Small changes in caloric intake can result in small but meaningful healthier weights."Back to top
*America On the Move® is a study funded by McNeil Nutritionals, LLC and a grant from the National Institutes of Health.
America On the Move® is a national initiative promoting people to lead a healthy lifestyle. America On the Move® is a trademark of America On the Move Foundation, Inc.
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