Health Care Professionals Archives - Calorie Control Council Healthy Eating & Exercise for Life Fri, 12 Apr 2024 18:41:59 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 References: The Gut Microbiome http://www.boxiang.co/?fat=references-the-gut-microbiome/ Fri, 12 Apr 2024 18:34:42 +0000 http://www.boxiang.co/?fat=?page_id=18780

References:   1.  Rostgaard-Hansen, et al. 2024 Temporal gut microbiota variability and association with dietary patterns: From the one-year observational Diet, Cancer, and Health – Next Generations MAX study. https://doi.org/10.1016/j.ajcnut.2024.01.027 David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh […]

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References:

 

1.  Rostgaard-Hansen, et al. 2024 Temporal gut microbiota variability and association with dietary patterns: From the one-year observational Diet, Cancer, and Health – Next Generations MAX study. https://doi.org/10.1016/j.ajcnut.2024.01.027

David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11. PMID: 24336217; PMCID: PMC3957428.

Wu GD, et al. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011;334:105–108.

Muegge BD, et al. Diet drives convergence in gut microbiome functions across mammalian phylogeny and within humans.

 

2.  Thomson P, Santibañez R, Aguirre C, Galgani JE, Garrido D. Short-term impact of sucralose consumption on the metabolic response and gut microbiome of healthy adults. British Journal of Nutrition. 2019;122(8):856-862. doi:10.1017/S0007114519001570

Ahmad SY, Friel J, Mackay D. The Effects of Non-Nutritive Artificial Sweeteners, Aspartame and Sucralose, on the Gut Microbiome in Healthy Adults: Secondary Outcomes of a Randomized Double-Blinded Crossover Clinical Trial. Nutrients. 2020; 12(11):3408. https://doi.org/10.3390/nu12113408 

Serrano, J., Smith, K.R., Crouch, A.L. et al. High-dose saccharin supplementation does not induce gut microbiota changes or glucose intolerance in healthy humans and mice. Microbiome 9, 11 (2021). https://doi.org/10.1186/s40168-020-00976-w

 

3.  Lobach AR, Roberts A, Rowland IR. Assessing the in vivo data on low/no-calorie sweeteners and the gut microbiota. Food Chem Toxicol. 2019 Feb;124:385-399. doi: 10.1016/j.fct.2018.12.005. Epub 2018 Dec 14. PMID: 30557670. https://pubmed.ncbi.nlm.nih.gov/30557670/ 

 

 

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LNCS:  Safety, Efficacy, & Role in the Diet http://www.boxiang.co/?fat=safety-efficacy-role-in-the-diet/ Tue, 23 Jan 2024 20:26:31 +0000 http://www.boxiang.co/?fat=?page_id=18768

Proven Safety of Low and No-Calorie Sweeteners The world’s most highly regarded global scientific and regulatory food agencies, including the Food & Drug Administration and The World Health Organization maintain that low- and no-calorie sweeteners are safe for consumption. Resources on the benefits and proven safety of low- and no- calorie sweeteners: WHO Joins Global […]

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Proven Safety of Low and No-Calorie Sweeteners

The world’s most highly regarded global scientific and regulatory food agencies, including the Food & Drug Administration and The World Health Organization maintain that low- and no-calorie sweeteners are safe for consumption.

Resources on the benefits and proven safety of low- and no- calorie sweeteners:

 

Findings from the SWITCH Study 52-Week Active Weight Management Phase

A new study, Non-Nutritive Sweetened Beverages Versus Water After a 52-week Weight Management Program: A Randomized Controlled Trial,” set out to compare the effects of non-nutritive sweetened (NNS) beverages and water on body weight. As part of the larger SWITCH study, the current study was published in the Obesity Journal, and reports results following both the 12-week active weight loss and 40-week weight maintenance phases. The results were recently presented at The Obesity Society’s Obesity Week conference. READ MORE.

 

Managing Sugar Intake Through Low and No-Calorie Sweeteners:  Georgetown University Whitepaper

Business for Impact at Georgetown University’s McDonough School of Business developed this whitepaper to evaluate the role low- and no-calorie sweeteners (LNCS) can play in achieving public health recommendations to reduce added sugars in the diet. This new paper increases understanding about the use, purpose, safety and benefits of LNCS in the food supply, demonstrates LNCS are a beneficial tool to help individuals achieve public health recommendations, and will help guide more effective policy decisions, better dietary guidance, and enlightened industry actions to enhance consumer health.

LNCS are commonly used in the food supply to help reduce caloric and sugar ‎intake. This whitepaper sponsored by the Calorie Control Council examines the current state of LNCS usage, the benefits and safety of LNCS consumption, consumer ‎perspectives regarding the utilization and labeling of sugar and LNCS, and projections for how much sugar and ‎calories can be removed from the food supply by increasing the incorporation of LNCS into foods and ‎beverages. Among the key findings of this paper are:

  • Three-quarters of consumers want ‎to limit or avoid their sugar intake, and LNCS are a viable option to help them achieve this goal.
  • The preponderance of evidence shows that LNCS can be consumed safely, and the most rigorous studies (randomized control trials) have repeatedly demonstrated their utility in weight management.
  • The number of food ‎products containing LNCS is currently low; LNCS alone or in combination with added sugars are contained in only 8% and 5%, respectively, of products in the marketplace.‎

According to the current analyses, increasing the incorporation of LNCS within permitted regulatory limits can ‎contribute to the potential reduction of seventy billion grams of added sugar and ‎two hundred twenty-five billion calories in the diet. Government and public health officials are urged to prioritize consumer and media ‎education about the benefits of LNCS in mitigating the obesity crisis.‎

Read the whitepaper

Watch the on-demand panel discussion:

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Low- and No-Calorie Sweetener Whitepaper http://www.boxiang.co/?fat=low-and-no-calorie-sweetener-whitepaper/ Thu, 19 Oct 2023 16:42:40 +0000 http://www.boxiang.co/?fat=?page_id=18737

Managing U.S. Sugar Intake Through Low and No-Calorie Sweeteners Business for Impact at Georgetown University’s McDonough School of Business developed this whitepaper to evaluate the role low- and no-calorie sweeteners (LNCS) can play in achieving public health recommendations to reduce added sugars in the diet. This new paper increases understanding about the use, purpose, safety and benefits […]

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Managing U.S. Sugar Intake Through Low and No-Calorie Sweeteners

Business for Impact at Georgetown University’s McDonough School of Business developed this whitepaper to evaluate the role low- and no-calorie sweeteners (LNCS) can play in achieving public health recommendations to reduce added sugars in the diet. This new paper increases understanding about the use, purpose, safety and benefits of LNCS in the food supply, demonstrates LNCS are a beneficial tool to help individuals achieve public health recommendations, and will help guide more effective policy decisions, better dietary guidance, and enlightened industry actions to enhance consumer health.

LNCS are commonly used in the food supply to help reduce caloric and sugar ‎intake. This whitepaper sponsored by the Calorie Control Council examines the current state of LNCS usage, the benefits and safety of LNCS consumption, consumer ‎perspectives regarding the utilization and labeling of sugar and LNCS, and projections for how much sugar and ‎calories can be removed from the food supply by increasing the incorporation of LNCS into foods and ‎beverages. Among the key findings of this paper are:

  • Three-quarters of consumers want ‎to limit or avoid their sugar intake, and LNCS are a viable option to help them achieve this goal.
  • The preponderance of evidence shows that LNCS can be consumed safely, and the most rigorous studies (randomized control trials) have repeatedly demonstrated their utility in weight management.
  • The number of food ‎products containing LNCS is currently low; LNCS alone or in combination with added sugars are contained in only 8% and 5%, respectively, of products in the marketplace.‎

According to the current analyses, increasing the incorporation of LNCS within permitted regulatory limits can ‎contribute to the potential reduction of seventy billion grams of added sugar and ‎two hundred twenty-five billion calories in the diet. Government and public health officials are urged to prioritize consumer and media ‎education about the benefits of LNCS in mitigating the obesity crisis.‎

Additional resources on the benefits and proven safety of low- and no- calorie sweeteners can be found below:

Read the whitepaper

Watch the on-demand panel discussion

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Findings from the SWITCH Study 52-Week Active Weight Management Phase http://www.boxiang.co/?fat=findings-from-the-switch-study-52-week-active-weight-management-phase/ Mon, 16 Oct 2023 23:31:55 +0000 http://www.boxiang.co/?fat=?p=18731

A new study, “Non-Nutritive Sweetened Beverages Versus Water After a 52-week Weight Management Program: A Randomized Controlled Trial,” set out to compare the effects of non-nutritive sweetened (NNS) beverages and water on body weight. As part of the larger SWITCH study, the current study was published in the Obesity Journal, and reports results following both the 12-week active weight loss and […]

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A new study, Non-Nutritive Sweetened Beverages Versus Water After a 52-week Weight Management Program: A Randomized Controlled Trial,” set out to compare the effects of non-nutritive sweetened (NNS) beverages and water on body weight. As part of the larger SWITCH study, the current study was published in the Obesity Journal, and reports results following both the 12-week active weight loss and 40-week weight maintenance phases. The results were recently presented at The Obesity Society’s Obesity Week conference.

Key findings from the study include:

  • Weight loss was consistently greater with the NNS beverages group compared to water.
  • The maximum weight loss was reached at week 36 with NNS beverages and week 44 with water.
  • Both groups started regaining weight after these timepoints, but the NNS beverage group regained weight at a slower rate than the water group.
  • Activity levels increased from baseline with the non- nutritive sweetened beverages group.

In the study, the authors report that the greatest rate of weight loss occurred during the first 12 weeks of the trial in both groups. Weight loss appeared to be greater with non-nutritive sweetened (NNS) beverages compared with water from the beginning of the trial. Maximum weight loss was reached at week 44 with water and week 36 with NNS beverages. Both groups started to regain weight after these timepoints, with a slower rate of increase in the NNS beverages group compared with the water group.

At week 52, both groups had significant reductions in body weight from baseline, with a mean weight change of –6.1 kg (-13.4 lbs.) with water versus –7.5 kg (-16.5 lbs.) with NNS beverages for the primary analysis using the complete cases data set. There was a significant difference in the changes from baseline between the groups, as the weight loss with NNS beverages was significantly greater than weight loss with water.

In primary analyses using the complete cases data set, baseline waist circumference had a significant effect on week-52 waist measurement, while both baseline hip circumference and assigned NNS beverages had a significant effect on week-52 hip measurements. There was a significant difference between groups in the changes in high-density lipoprotein cholesterol, driven by a modest increase from baseline in the NNS beverages group (0.0 vs. 0.1 mmol/l). There were no significant differences between groups for the changes in the other biomarkers assessed.

There were no significant changes in hunger consumption from baseline in either treatment group, while sweetener consumption (caloric or non-caloric) was significantly reduced from baseline in the water group, but not the NNS beverages group (–13.1 vs. +1.2 score points), resulting in a statistically significant difference between them, as expected. Sugar consumption was significantly reduced from baseline to a similar extent in both groups. Activity levels, measured as the average number of steps taken per day over 1 week, decreased with water but increased significantly from baseline with NNS beverages at week 52; however, the difference between the groups was not significant.

Overall, the authors concluded that the difference in body weight between water and NNS beverages at the end of this phase was non-equivalent. In next steps, the final voluntary 52-week period of unassisted weight maintenance in this trial will assess whether the discontinuation of routine nutrition awareness visits will have an impact on further maintaining weight loss or preventing weight gain in both groups.

This publication was presented by Jason Halford on October 16, 2023 at Obesity Week in Dallas, Texas.

Conclusion: During a 52-week behavioral weight management program, water and NNS beverages were non-equivalent, with weight loss maintained to a statistically greater extent with NNS beverages compared with water.

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Statement from CCC on “Artificial Sweeteners and Risk of Cardiovascular Diseases: Results from the Prospective NutriNet-‎Santé Cohort” http://www.boxiang.co/?fat=flaws-with-artificial-sweeteners-and-risk-of-cardiovascular-diseases-results-from-the-prospective-nutrinet-sante-cohort/ Fri, 09 Sep 2022 13:43:55 +0000 http://www.boxiang.co/?fat=?p=18387

A study published in the British Medical Journal entitled, “Artificial Sweeteners and Risk of Cardiovascular Diseases: Results from the Prospective NutriNet-‎Santé Cohort” sought to evaluate the association between low- and no-calorie sweetener intake and cardiovascular ‎disease risk. The study authors report an association between sweetener intake and increased risk of cardiovascular and cerebrovascular disease. Further, […]

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A study published in the British Medical Journal entitled, “Artificial Sweeteners and Risk of Cardiovascular Diseases: Results from the Prospective NutriNet-‎Santé Cohort” sought to evaluate the association between low- and no-calorie sweetener intake and cardiovascular ‎disease risk. The study authors report an association between sweetener intake and increased risk of cardiovascular and cerebrovascular disease. Further, they report an increased risk of cerebrovascular events with aspartame intake, as well as an association between acesulfame potassium and sucralose consumption with increased coronary heart disease risk. Like the previous study conducted by this group, which investigated associations between low- and no-calorie sweeteners and cancer, these allegations are contrary to decades of scientific research showing these sweeteners are safe, as evidenced by global regulatory permissions for their use.

Due to the sample utilized in this study, the results of this study cannot and should not be extrapolated to the general population, as ‎those who volunteer to participate in such research activities often exhibit unique ‎characteristics (i.e., lifestyle and socioeconomic factors, etc.) not typical of the broader ‎population. ‎These individuals also self-reported their intake data, which subjects the ‎current study to recall bias, misreporting and under-reporting. Lastly, the observational nature of this study inhibits the ability to establish causality and the ‎likelihood of residual confounding bias must be considered when interpreting ‎these results.‎ ‎

Consumers want options when it comes to sugar reduction and low- and no-calorie sweeteners have are a proven safe and effective choice for sugar and calorie reduction. Along with exercise and a healthy diet, low- and no-calorie sweeteners are a critical tool that can help consumers manage body weight and reduce the risk of non-communicable diseases, such as cardiovascular disease and diabetes.

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CCC Statement: “Health effects of the use of non-sugar sweeteners – A systematic review and meta-analysis” http://www.boxiang.co/?fat=ccc-statement-health-effects-of-the-use-of-non-sugar-sweeteners-a-systematic-review-and-meta-analysis/ Thu, 21 Apr 2022 14:34:27 +0000 http://www.boxiang.co/?fat=?p=18333

The recent publication by Rios-Leyvraz and Montez, entitled “Health effects of the use of non-sugar sweeteners – a systemic review and met-analysis,” serves as an update to the 2019 systematic review by Toews, et al. and attempts to address inherent health effects of non-sugar sweeteners (NSS) as well as those effects compared to sugar or […]

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The recent publication by Rios-Leyvraz and Montez, entitled “Health effects of the use of non-sugar sweeteners – a systemic review and met-analysis,” serves as an update to the 2019 systematic review by Toews, et al. and attempts to address inherent health effects of non-sugar sweeteners (NSS) as well as those effects compared to sugar or water, when consumed at safe levels as established by authoritative bodies.

The review reports favorable findings regarding NSS intake and weight management outcomes, without significant effects on other measures of adiposity or cardiometabolic health, including ‎fasting glucose, insulin, blood lipids and blood ‎pressure (very low to high certainty evidence).‎

Although long-term cohort studies suggested less favorable outcomes, the evidence certainty is very low to low. The authors note that these findings may be due to reverse causation and/or residual confounding.

Based on the lack of significant data from studies involving children, as well as largely inconclusive results in those that exist, and very low to low certainty of evidence regarding pregnant women, it is recommended more research is necessary to investigate consumption among these two population groups.

The review concluded that NSS consumption may be associated with short-term weight loss when used to reduce total energy intake. These results are largely in agreement with the findings of other systemic reviews and the current body of evidence. 

Additionally, numerous health and regulatory organizations from around the world maintain their confirmation of the safety of low- and no-calorie sweeteners for consumption by the general population. The unified position of worldwide food safety authorities is supported by robust evidence and extensive research, which contradict the recent review’s conclusions regarding long-term effects.

Given the totality of evidence and official assessments in support of low- and no-calorie sweeteners, CCC maintains that these ingredients are safe and valuable tools to aid in sugar reduction, weight management, blood glucose management and other positive outcomes.

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Weaknesses of “Artificial sweeteners and cancer risk: Results from the NutriNet-Sante’ ‎population-based cohort study” http://www.boxiang.co/?fat=ccc-staff-summary-of-artificial-sweeteners-and-cancer-risk-results-from-the-nutrinet-sante-population-based-cohort-study/ Thu, 24 Mar 2022 19:19:31 +0000 http://www.boxiang.co/?fat=?p=18315

The study entitled, “Artificial Sweeteners and Cancer Risk: Results from the NutriNet-Sante´ Population-Based Cohort ‎Study,” attempted to evaluate any association between low- and no-calorie sweetener (LNCS) intake and cancer risk. However, the reported findings of this study are in contradiction to the totality of evidence and the numerous global health organizations who have regarded each […]

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The study entitled, “Artificial Sweeteners and Cancer Risk: Results from the NutriNet-Sante´ Population-Based Cohort ‎Study,” attempted to evaluate any association between low- and no-calorie sweetener (LNCS) intake and cancer risk. However, the reported findings of this study are in contradiction to the totality of evidence and the numerous global health organizations who have regarded each of the named sweeteners as safe, following rigorous assessments.  

Despite its longitudinal design and large sample size, the current study has several weaknesses. Self-reported intake data subjects the study to recall bias, misreporting and under-reporting. Further, given the observational nature of this study design, causal links cannot be established and the likelihood of residual confounding bias must be considered when interpreting ‎these results.‎ Lastly, the results of this study cannot and should not be extrapolated to the general population, as ‎those who volunteer to participate in such research activities often exhibit unique ‎characteristics (i.e., lifestyle and socioeconomic factors, etc.) not typical of the broader ‎population. ‎All of these considerations significantly limit the strength of the reported findings.

In conclusion, CCC emphasizes LNCS remain safe and effective tools in weight management, sugar reduction and blood glucose management.

For more information on the safety of low- and no- calorie sweeteners, review the frequently asked questions below:

Is there any evidence that low- and no-calorie sweeteners cause cancer?
The overall body of scientific evidence regarding low-and no-calorie sweeteners (LNCS) does not support an association between consumption and cancer risk. Global scientific authorities and food safety agencies have assessed the totality of available evidence and have concluded that each of the approved sweeteners are safe.
Is aspartame safe?
Regulatory agencies in more than 100 countries have all affirmed aspartame’s safety. The scientific evidence overwhelmingly supports the safety of aspartame even in amounts far greater than people typically consume.

With more than 200 studies attesting to its safety, aspartame is one of the most researched food additives in the world and has a long history of safe use. A thorough review of the research by The European Food Safety Authority released in 2013 concluded that aspartame is safe for the general population including infants, children and pregnant women. Scientists from the U.S. Food & Drug Administration (FDA) have also reviewed the scientific data regarding the safety of aspartame in food and concluded that it is safe for the general population. According to the U.S. Department of Agriculture, aspartame is one of the most exhaustively studied substances in the human food supply.

Since aspartame contains phenylalanine, aspartame is not recommended for individuals with phenylketonuria (PKU), a rare hereditary disease, who have difficulty in metabolizing phenylalanine.

In 2012 Academy of Nutrition and Dietetics (AND) stated, “Consumers can safely enjoy a range of nutritive sweeteners and nonnutritive sweeteners (NNS) when consumed within an eating plan that is guided by current federal nutrition recommendations, such as the Dietary Guidelines for Americans and the Dietary Reference Intakes, as well as individual health goals and personal preference.” In reference to any adverse effects aspartame related to aspartame consumption, AND concluded, “Aspartame consumption is not associated with adverse effects in the general population.”

Does Ace-K cause cancer?
No. All substances that are intended to be added to food must undergo extensive tests to ensure their safety. At the center of these studies are tests to determine whether the substances have any carcinogenic or cancer-promoting effect. Only substances not suspected of having such an effect are approved for use in food by the relevant agencies.
What are some of the lifestyle and socioeconomic factors that make this study inapplicable to the general population?
In general, individuals who participate in volunteer-based cohorts tend to be women, have higher educational and socio-professional levels, and tend to exhibit more health-conscious lifestyle behaviors.

What is residual confounding bias, and why does it apply to the results of this study?
“Residual confounding” is a term that refers to the relationship between exposure (in this case, LNCS consumption) and an outcome (i.e., cancer risk). Whereas typically, exposure proceeds an outcome, in some cases, this is reversed. In observational studies, conclusions regarding causality are not possible.
Why should I use an low or no-calorie sweetener instead of regular sugar?
Low-calorie products provide consumers with many benefits. Whether by choice or necessity, millions of Americans restrict their intake of calories, carbohydrates and fats. According to opinion research, most people consume low-calorie products to stay in better overall health, eat or drink healthier foods and beverages, maintain weight, reduce weight or maintain an attractive physical appearance. Most people use low-calorie products as part of an overall healthy lifestyle. Research also shows that health professionals believe low-calorie sweeteners are especially beneficial to obese individuals and those with diabetes. Low-calorie sweeteners also do not promote dental cavities.

For more aspartame FAQs, click here.

For more Ace-K FAQs, click here.

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Network Analysis Reinforces Benefits of Low- And No- Calorie Sweetened Beverages http://www.boxiang.co/?fat=network-analysis-reinforces-benefits-of-low-and-no-calorie-sweetened-beverages/ Mon, 14 Mar 2022 21:24:55 +0000 http://www.boxiang.co/?fat=?p=18311

(Download) McGlynn ND, Khan TA, Wang L, et al. JAMA Network Open. 2022;5(3):e222092. doi:10.1001/jamanetworkopen.2022.2092 A recent review published in JAMA Network Open examined the association of low- and no-calorie sweetened beverages (LNCSBs) with body weight and cardiometabolic risk factors in adults with and without diabetes. Recent trials and reviews have reported inconsistent findings regarding these […]

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(Download)

McGlynn ND, Khan TA, Wang L, et al.

JAMA Network Open. 2022;5(3):e222092. doi:10.1001/jamanetworkopen.2022.2092

A recent review published in JAMA Network Open examined the association of low- and no-calorie sweetened beverages (LNCSBs) with body weight and cardiometabolic risk factors in adults with and without diabetes. Recent trials and reviews have reported inconsistent findings regarding these outcomes, and methodological considerations limit the conclusions that can be drawn from their reported results. For example, the authors note that the syntheses of randomized controlled trials (RCTs) do not fully account for the calories available to be displaced by LNCSBs, leading to an underestimation of the outcome of LNCSBs. In an effort to update the recommendations of the European Association for the Study of Diabetes, the Diabetes and Nutrition Study Group commissioned this new systematic review and meta-analysis to summarize evidence regarding the association of LNCSBs with intermediate cardiometabolic outcomes, including:

  • Adiposity
  • Glycemic Control
  • Blood Lipids
  • Blood Pressure
  • Measures of Non-Alcoholic Fatty Liver Disease
  • Uric Acid

Medline, Embase and the Cochrane Central Register of Controlled Trials were utilized to search RCTs with at least 2 weeks of interventions comparing LNCSBs, sugar-sweetened beverages (SSBs), and/or water (the standard of care substitution) from inception through December 2021. In contrast with the standard pairwise approach, researchers conducted a network meta-analysis, which allowed for the simultaneous assessment of three pre-specified substitutions (i.e., LNCSBs for SSBs, water for SSBs, and LNCSBs for water). This approach leverages direct and indirect comparisons with a common comparator to increase the information size, allowing for more precise estimates and the comparison of interventions that have not been previously compared.

Seventeen RCTs with twenty-four trial comparisons were included in the network meta-analysis. In total, the sample included 1733 adults with an average age of 33 years. The majority of included individuals (77.4%) were women who were overweight or obese and at-risk for or diagnosed with diabetes. In 12 of the RCTs included, LNCSBs were a substitute for SSBs, while 3 RCTs used water was a substitute for SSBs. LNCSBs were a substitute for water in 9 RCTs.

Network analyses of the prespecified substitutions yielded the following results:

  • Substitution of LNCSBs for SSBs (intended substitution with caloric displacement) was associated with reduced body weight body mass index, percentage of body fat, and intrahepatocellular lipid.
  • Substitution of water for SSBs (standard-of-care substitution with caloric displacement) was not associated with any outcome, although the direction of association favored water for most of the outcomes.
  • Substitution of LNCSBs for water (reference substitution without caloric displacement) was associated with lower-level glycated hemoglobin A1C seen with water and decreased body weight and systolic blood pressure with LNCSBs.

Certainty of the evidence assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Network estimates of RCTs and the direct and indirect estimates that composed these network estimates started at a high certainty of evidence but were downgraded by established criteria for risk of bias, inconsistency (incoherence), indirectness, imprecision, and publication bias. As a result, for the body weight outcome, the certainty of the evidence was rated as “moderate” for the substitution of LNCSBs for SSBs, and “low” for substitutions of water for SSBs and LNCSBs for water. The certainty of evidence was generally moderate for all other outcomes across all substitutions.

The findings in this study are in agreement with those reported in other systematic reviews and meta-analyses, which have allowed for the interpretation of results by comparator. Previous analyses have also reported reduced body weight, BMI, and body fat associated with the use LNCSBs as a substitute for SSBs with caloric displacement, which is consistent with the utility of LNCSBs in reducing net energy intake. Neutral outcomes associated with the use of LNCSBs as a substitute for water without caloric displacement were reported in previous analyses. The authors note, “Although water is considered to be the standard-of-care substitution for SSBs by authoritative bodies, with many health organizations recommending against the use of LNCSBs, the existing evidence confirms the intended benefits of LNCSBs as a substitute for SSBs over the moderate term.”

In conclusion, the authors state, “There is a need for high-quality RCTs that focus on quantifying the outcome of LNCSBs using different LNCS blends as substitutes for SSBs compared with the outcome of water (the standard-of care substitution).” They note that their findings provide a good indication of the benefits of LNCSBs as an alternative replacement strategy over the moderate term for SSBs in adults with overweight or obesity who are at risk for or have diabetes. Future research using a range of designs is warranted to confirm whether the intended benefits of using LNCSBs as a substitute for SSBs are durable and extend to hard clinical outcomes.

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Recent Research Strengthens Body of Evidence for Latin American Sweetener Intake Estimates http://www.boxiang.co/?fat=recent-research-strengthens-body-of-evidence-for-latin-american-sweetener-intake-estimates/ Mon, 14 Mar 2022 19:04:55 +0000 http://www.boxiang.co/?fat=?p=18308

A manuscript entitled, “Low- and No-Calorie Sweetener Intakes in the Brazilian Population Estimated Using Added Sugar Substitution Modelling” has been published in the Food Additives & Contaminants: Part A journal. Given the lack of data available on replacing added sugars with low- and no-calorie sweeteners (LNCS) in foods and beverages for many regions globally, the […]

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A manuscript entitled, “Low- and No-Calorie Sweetener Intakes in the Brazilian Population Estimated Using Added Sugar Substitution Modelling” has been published in the Food Additives & Contaminants: Part A journal. Given the lack of data available on replacing added sugars with low- and no-calorie sweeteners (LNCS) in foods and beverages for many regions globally, the aim of this assessment was two-fold:

  • Estimating daily intakes six LNCS (acesulfame-K, aspartame, cyclamate, saccharin, steviol ‎glycosides, and sucralose) within ‎the Brazilian population; and
  • Examining alternative models for ‎assessing intakes of these sweeteners which do not involve use-level information (i.e., utilizing an added sugar substitution approach).

Each intake estimate was derived from documented added sugar intakes in the Brazilian population ‎and reported levels of added sugar in food, in conjunction with sucrose sweetness ‎equivalence data for each LNCS and usage patterns in the Brazilian market. The resulting intake estimate was then ‎compared to the sweetener’s Acceptable Daily Intake (ADI), a conservative calculation of the amount of a substance a person can consume on a daily basis for their lifetime without adverse effects established by the Joint FAO/WHO Expert Committee on Food ‎Additives (JECFA) for all population groups.‎

In both replacement models, researchers found that the intakes of all LNCS included in the study, except for cyclamate, were below the ADI by average (mean) and ‎heavy LNCS consumers (90th and 95th percentiles) for all population groups over 10 years of age.‎ However, it was noted that the assessment does not represent realistic patterns of replacement based on actual usage patterns of LNCS, which would vary by product type, and is not the most suitable for LNCS that have a high sucrose sweetness equivalence, such as cyclamate.

This work contributes to the body of evidence for intake estimates for Latin America, and Brazil specifically, which were previously quite limited. Additional research is needed for younger age groups to confirm whether these findings are applicable to the entire Brazilian population.

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Commentary on the Recent Review by Lea (2021) ‎Concluding Overall Lack of Genotoxic Activity for LNCS http://www.boxiang.co/?fat=commentary-on-the-recent-review-by-lea-2021-%e2%80%8econcluding-overall-lack-of-genotoxic-activity-for-lncs/ Thu, 03 Feb 2022 23:02:04 +0000 http://www.boxiang.co/?fat=?p=18285

By Dr. Berna Magnuson Introduction  Low- and no-calorie sweeteners (LNCS) are widely approved for use in foods and beverages to provide sweetness with no or few calories and no increase in blood glucose levels. The safety of these ingredients has been intensively investigated and assessed by authoritative bodies globally. When new toxicological assessment tools and […]

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By Dr. Berna Magnuson

Introduction 

Low- and no-calorie sweeteners (LNCS) are widely approved for use in foods and beverages to provide sweetness with no or few calories and no increase in blood glucose levels. The safety of these ingredients has been intensively investigated and assessed by authoritative bodies globally. When new toxicological assessment tools and new studies are generated, re-evaluation of safety by considering the totality of the database becomes warranted. Recently, Lea and colleagues (2021) focused on one aspect of food additive safety, the genotoxic potential of five LNCS. Their review of the literature, evaluation of the potential for genotoxic activity of these ingredients using a weight-of-evidence approach, and conclusions are reported here.  

This article provides a brief background to genotoxicity and testing methods, how quality and reliability of studies are determined, and why weight-of-evidence evaluations for overall safety assessment are conducted and are necessary.

What is genotoxicity and how is it measured?

Briefly, genotoxicity is damage to the genetic material of cells. There are different types of genotoxicity and over 100 different genotoxicity tests.  The 3 categories of genotoxicity tests are: 1) tests that measure mutations to DNA; 2) tests that measure clastogenicity (disruption or breakage of chromosomes) and/or aneugenicity (change in number of chromosomes); and 3) indicator tests that provide indirect measures of DNA damage such as single strand breaks, DNA repair response or changes in gene expression. Lea and colleagues summarize the assays used to evaluate these genotoxic effects in Table 1. Additionally, as DNA mutations are considered initiating events in cancer development, the absence of carcinogenic response in tumor studies in animals can be considered additional evidence of lack of genotoxicity potential of a compound.

How are quality and reliability of studies evaluated?

Many hundreds of various genotoxicity and carcinogenicity studies have been conducted on the 5 LNCS. If they do not all agree, how do evaluators determine which ones are providing the correct answers?

The different test protocols used to evaluate the genotoxicity of LNCS are not considered equal in their relevance for risk assessment. For example, only specific tests conducted according to internationally accepted testing guidelines are accepted by regulatory agencies for safety evaluation and approval of food ingredients. These are referred to as “guideline” studies (OECD website) and are globally recognized and accepted by regulatory agencies. Such tests are conducted according to protocols specified in the guidelines, with appropriate negative and positive controls, background control incidence and historical data on controls, and sufficient documentation of conditions and results. These guideline studies have been shown to be highly reliable, robust, and relevant for the endpoint being measured. Examples of factors that determine if a test is considered high quality and reliable include: (1) a correct test outcome for known positive and negative agents, with dose-response for positive agents; (2) the reproducibility and extent of within-test variability among laboratories (i.e. what is frequency of false positives and false negatives?); and (3) established limitations and confounders of the test  (such as cytotoxicity, apoptosis, DNA fragmentation). For further examples and discussion, visit the National Institute of Environmental Health Sciences (NIEHS) website.

What is a weight-of-evidence (WoE) approach for risk assessment and why is it used?

The results and conclusions of genotoxicity and other toxicology studies that are not conducted according to approved guidelines can be and are published in the scientific literature, often with much publicity.  Multiple reports with conflicting conclusions can pose a very confusing picture for health professionals and scientists who are not familiar with the limitations and lack of reliability of some of the studies.

WoE is a decision-making method in risk assessment that involves compiling a database of toxicology studies and assigning “weight” to each study based on the reliability of the study. Thus, the findings of those studies considered most reliable would be “weighed” more heavily in the overall assessment than findings from studies with lower or questionable reliability due to specified reasons or limitations (no dose-response, insufficient controls or replications, etc.). Thus, WoE assessments are used to review all the available data, provide clear rationales for reliability differences and weighing of results from various sources, and provide overall conclusions.

Summary of Lea et al (2021)

Lea and colleagues (2021) conducted a WoE assessment of the genotoxicity potential of each LNCS by compiling (1) reviews of genotoxicity studies by regulatory agencies, (2) recently published genotoxicity tests, (3) EPA Toxicity Forecaster database of results from high-throughput screening (HTS) for indirect measures of genotoxicity such as DNA damage and gene expression, and (4) conclusions from recent assessments of carcinogenic potential of the LNCS using Key Characteristics of Carcinogens (KCC). Overall summaries of the results from mutagenicity assays, chromosomal change assays, other DNA damage, and regulatory agency reviews are presented in very brief tables for clarity.

The overwhelming evidence from the majority of the various studies shows a lack of genotoxicity of the LNCS, with occasional reports of positive, genotoxic responses. This pattern of random “misleading” or “irrelevant” positive results among databases for non-genotoxic compounds is not uncommon, as described by an Expert Panel on the evaluation of new genotoxicity assays (Kirkland et al, 2016). To address this issue for LNCS, Lea et al. (2021) provided detailed explanations of the limitations or concerns for the studies with conflicting results. Justification is explained in detail for giving less weight in the overall genotoxicity assessment to results from unreliable studies compared to those from other high-quality guideline studies. Lea and colleagues (2021) offer further support for their conclusions regarding the non-genotoxicity of LNCS with additional and novel incorporation of mechanistic data from the emerging field of toxicology (ToxCast/Tox21) using high-throughput screening (HTS). In addition, they describe findings from the mechanistic framework using KCC that demonstrate lack of carcinogenic potential for LNCS.

Conclusion

In conclusion, the review by Lea and colleagues (2021) is a comprehensive assessment of genotoxicity potential of LNCS, using both historical and recent laboratory studies, and supported by mechanistic analyses.

Their conclusions of an overall lack of mutagenic and genotoxic activity based on the growing body of evidence further support of the safety of use of approved LNCS.

References

Kirkland D, Kasper P, Martus H-J, Müller L, van Bentheme J, Madiaf F, Corvif R (2016) Updated recommended lists of genotoxic and non-genotoxic chemicals for assessment of the performance of new or improved genotoxicity tests. Mutat Res 795:7-30.

Lea, Isabel & Chappell, Grace & Wikoff, Daniele. (2021). Overall lack of genotoxic activity among five common low- and no-calorie sweeteners: A contemporary review of the collective evidence. Mutation Research/Genetic Toxicology and Environmental Mutagenesis. 868-869. 503389. 10.1016/j.mrgentox.2021.503389.

NIEHS (National Institute of Environmental Health Sciences), Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods, NIH Publication No. 97-3981, NIEHS, Research Triangle Park, North Carolina, U.S.A., 1997.

https://ntp.niehs.nih.gov/iccvam/docs/about_docs/validate.pdf

OECD Test Guidelines Programme

https://www.oecd.org/chemicalsafety/testing/oecd-guidelines-testing-chemicals-related-documents.htm

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