Stevia for Childhood Obesity
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Arkansas Children's Hospital Research Institute
No Placebo Group
Trial Summary
What is the purpose of this trial?This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.
The main purpose of the study is to evaluate if stevia (as with other sweeteners and consistent with prior research in children and adults) has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if your medications affect the outcomes of interest, you may be excluded from the trial.
Is Stevia a promising treatment for childhood obesity?Yes, Stevia is a promising treatment for childhood obesity because it is a natural, zero-calorie sweetener that can replace sugar in drinks and foods, helping to reduce calorie intake and manage weight.167810
What data supports the idea that Stevia for Childhood Obesity is an effective treatment?The available research shows that substituting sugar-free beverages, like those sweetened with Stevia, for sugar-sweetened ones can help reduce weight gain in children, especially those with a higher body mass index (BMI). This suggests that using Stevia-sweetened drinks instead of sugary ones might be effective in managing childhood obesity. However, there is also a concern about the overuse of non-caloric sweeteners, including Stevia, in children's foods and drinks, which could lead to excessive consumption. While Stevia may help reduce sugar intake, the research advises caution in its prolonged use by children.4791012
What safety data exists for using stevia in treating childhood obesity?Stevia, a low-calorie sweetener, has been affirmed as safe by several food regulatory and safety authorities worldwide. It has been approved in the United States through the Generally Recognized as Safe (GRAS) system, which requires a high level of scientific evidence to ensure safety. The European Food Safety Authority (EFSA) has also evaluated steviol glycosides, concluding that their inclusion in food products is not of safety concern, provided they meet specific purity standards. The acceptable daily intake (ADI) for steviol glycosides is set at 4 mg/kg body weight per day. However, there is limited data on its effects on energy intake, weight management, and the gut microbiome, which are relevant to childhood obesity.235611
Eligibility Criteria
The Sweet Kids Study is for children aged 8-12 who regularly drink sugary beverages and are either of normal weight or overweight, but not severely obese. They should be willing to try new drinks and not have conditions like diabetes, chronic infections, hormonal diseases, severe asthma, bleeding disorders, certain mental health issues or a recent history of antibiotic use.Inclusion Criteria
My BMI is high, between 35 and less than 40, or it's in the top 15% for my age.
I am between 8 and 12 years old.
Exclusion Criteria
I have chronic kidney disease.
My child is classified with class 3 obesity.
I have asthma triggered by exercise.
I have been diagnosed with type 1 or type 2 diabetes.
I do not have chronic infections like HIV or hepatitis.
I have epilepsy.
I have a bleeding disorder like hemophilia.
I have an autoimmune disease like lupus or thyroiditis.
I use my asthma inhaler daily to control my severe asthma.
Treatment Details
This study compares the effects of three types of beverages on children's weight and metabolic function over an 8 to14-week period: water flavored without calories, drinks sweetened with stevia (a no-calorie sweetener), and drinks sweetened with regular sugar (sucrose).
3Treatment groups
Experimental Treatment
Active Control
Group I: Stevia sweetened beverageExperimental Treatment1 Intervention
The stevia-sweetened beverage contains 30.1 mg of steviol equivalents. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.
Group II: Calorie free flavored water beverageActive Control1 Intervention
Flavored water. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.
Group III: Sucrose sweetened beverageActive Control1 Intervention
Sucrose (i.e. sugar): 25 g sugar (100 Kcal per serving). Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.
Calorie free flavored water beverage is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Flavored water for:
- General hydration
- Dietary supplement
🇪🇺 Approved in European Union as Flavored water for:
- General hydration
- Dietary supplement
Find a clinic near you
Research locations nearbySelect from list below to view details:
Arkansas Children's Nutrition CenterLittle Rock, AR
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Who is running the clinical trial?
Arkansas Children's Hospital Research InstituteLead Sponsor
CargillIndustry Sponsor
References
Stevia rebaudiana Bertoni extract supplementation improves lipid and carnitine profiles in C57BL/6J mice fed a high-fat diet. [2015]Stevia (Stevia rebaudiana Bertoni) is a non-caloric natural-source alternative to artificially produced sugar substitutes. This study investigated the effect of stevia extract on lipid profiles in C57BL/6J mice. Forty mice were divided into four groups: N-C (normal diet and distilled water), H-C (high-fat diet and distilled water), H-SC (high fat diet and sucrose, 1 mL kg(-1) per day), and H-SV (high-fat diet and stevia extract, 1 mL kg(-1) per day).
Stevia and saccharin preferences in rats and mice. [2022]Use of natural noncaloric sweeteners in commercial foods and beverages has expanded recently to include compounds from the plant Stevia rebaudiana. Little is known about the responses of rodents, the animal models for many studies of taste systems and food intake, to stevia sweeteners. In the present experiments, preferences of female Sprague-Dawley rats and C57BL/6J mice for different stevia products were compared with those for the artificial sweetener saccharin. The stevia component rebaudioside A has the most sweetness and least off-tastes to human raters. In ascending concentration tests (48-h sweetener vs. water), rats and mice preferred a high-rebaudioside, low-stevioside extract as strongly as saccharin, but the extract stimulated less overdrinking and was much less preferred to saccharin in direct choice tests. Relative to the extract, mice drank more pure rebaudioside A and showed stronger preferences but still less than those for saccharin. Mice also preferred a commercial mixture of rebaudioside A and erythritol (Truvia). Similar tests of sweet receptor T1R3 knockout mice and brief-access licking tests with normal mice suggested that the preferences were based on sweet taste rather than post-oral effects. The preference response of rodents to stevia sweeteners is notable in view of their minimal response to some other noncaloric sweeteners (aspartame and cyclamate).
The safety and regulatory process for low calorie sweeteners in the United States. [2018]Low calorie sweeteners are some of the most thoroughly tested and evaluated of all food additives. Products including aspartame and saccharin, have undergone several rounds of risk assessment by the United States Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA), in relation to a number of potential safety concerns, including carcinogenicity and more recently, effects on body weight gain, glycemic control and effects on the gut microbiome. The majority of the modern day sweeteners; acesulfame K, advantame, aspartame, neotame and sucralose have been approved in the United States through the food additive process, whereas the most recent sweetener approvals for steviol glycosides and lo han guo have occurred through the Generally Recognized as Safe (GRAS) system, based on scientific procedures. While the regulatory process and review time of these two types of sweetener evaluations by the FDA differ, the same level of scientific evidence is required to support safety, so as to ensure a reasonable certainty of no harm.
Impact of Masked Replacement of Sugar-Sweetened with Sugar-Free Beverages on Body Weight Increases with Initial BMI: Secondary Analysis of Data from an 18 Month Double-Blind Trial in Children. [2018]Substituting sugar-free for sugar-sweetened beverages reduces weight gain. This effect may be more pronounced in children with a high body mass index (BMI) because their sensing of kilocalories might be compromised. We investigated the impact of sugar-free versus sugary drinks separately in children with a higher and a lower initial BMI z score, and predicted caloric intakes and degree of compensation in the two groups.
Biological fate of low-calorie sweeteners. [2018]With continued efforts to find solutions to rising rates of obesity and diabetes, there is increased interest in the potential health benefits of the use of low- and no-calorie sweeteners (LNCSs). Concerns about safety often deter the use of LNCSs as a tool in helping control caloric intake, even though the safety of LNCS use has been affirmed by regulatory agencies worldwide. In many cases, an understanding of the biological fate of the different LNSCs can help health professionals to address safety concerns. The objectives of this review are to compare the similarities and differences in the chemistry, regulatory status, and biological fate (including absorption, distribution, metabolism, and excretion) of the commonly used LNCSs: acesulfame potassium, aspartame, saccharin, stevia leaf extract (steviol glycoside), and sucralose. Understanding the biological fate of the different LNCSs is helpful in evaluating whether reports of biological effects in animal studies or in humans are indicative of possible safety concerns. Illustrations of the usefulness of this information to address questions about LNCSs include discussion of systemic exposure to LNCSs, the use of sweetener combinations, and the potential for effects of LNCSs on the gut microflora.
Stevia Leaf to Stevia Sweetener: Exploring Its Science, Benefits, and Future Potential. [2023]Steviol glycoside sweeteners are extracted and purified from the Stevia rebaudiana Bertoni plant, a member of the Asteraceae (Compositae) family that is native to South America, where it has been used for its sweet properties for hundreds of years. With continued increasing rates of obesity, diabetes, and other related comorbidities, in conjunction with global public policies calling for reductions in sugar intake as a means to help curb these issues, low- and no-calorie sweeteners (LNCSs, also known as high-potency sweeteners) such as stevia are gaining interest among consumers and food manufacturers. This appeal is related to stevia being plant-based, zero calorie and with a sweet taste that is 50-350 times sweeter than sugar, making it an excellent choice for use in sugar- and calorie-reduced food and beverage products. Despite the fact that the safety of stevia has been affirmed by several food regulatory and safety authorities around the world, insufficient education about stevia's safety and benefits, including continuing concern with regard to the safety of LNCSs in general, deters health professionals and consumers from recommending or using stevia. Therefore, the aim of this review and the stevia symposium that preceded this review at the ASN's annual conference in 2017 was to examine, in a comprehensive manner, the state of the science for stevia, its safety and potential health benefits, and future research and application. Topics covered included metabolism, safety and acceptable intake, dietary exposure, impact on blood glucose and insulin concentrations, energy intake and weight management, blood pressure, dental caries, naturality and processing, taste and sensory properties, regulatory status, consumer insights, and market trends. Data for stevia are limited in the case of energy intake and weight management as well as for the gut microbiome; therefore, the broader literature on LNCSs was reviewed at the symposium and therefore is also included in this review.
Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association. [2019]In the United States, 32% of beverages consumed by adults and 19% of beverages consumed by children in 2007 to 2010 contained low-calorie sweeteners (LCSs). Among all foods and beverages containing LCSs, beverages represent the largest proportion of LCS consumption worldwide. The term LCS includes the 6 high-intensity sweeteners currently approved by the US Food and Drug Administration and 2 additional high-intensity sweeteners for which the US Food and Drug Administration has issued no objection letters. Because of a lack of data on specific LCSs, this advisory does not distinguish among these LCSs. Furthermore, the advisory does not address foods sweetened with LCSs. This advisory reviews evidence from observational studies and clinical trials assessing the cardiometabolic outcomes of LCS beverages. It summarizes the positions of government agencies and other health organizations on LCS beverages and identifies research needs on the effects of LCS beverages on energy balance and cardiometabolic health. The use of LCS beverages may be an effective strategy to help control energy intake and promote weight loss. Nonetheless, there is a dearth of evidence on the potential adverse effects of LCS beverages relative to potential benefits. On the basis of the available evidence, the writing group concluded that, at this time, it is prudent to advise against prolonged consumption of LCS beverages by children. (Although water is the optimal beverage choice, children with diabetes mellitus who consume a balanced diet and closely monitor their blood glucose may be able to prevent excessive glucose excursions by substituting LCS beverages for sugar-sweetened beverages [SSBs] when needed.) For adults who are habitually high consumers of SSBs, the writing group concluded that LCS beverages may be a useful replacement strategy to reduce intake of SSBs. This approach may be particularly helpful for persons who are habituated to a sweet-tasting beverage and for whom water, at least initially, is an undesirable option. Encouragingly, self-reported consumption of both SSBs and LCS beverages has been declining in the United States, suggesting that it is feasible to reduce SSB intake without necessarily substituting LCS beverages for SSBs. Thus, the use of other alternatives to SSBs, with a focus on water (plain, carbonated, and unsweetened flavored), should be encouraged.
Effect of Steviol Glycosides on Human Health with Emphasis on Type 2 Diabetic Biomarkers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]The natural sweetener from Stevia rebaudiana Bertoni, steviol glycoside (SG), has been proposed to exhibit a range of antidiabetic properties. The objective of this systematic review was to critically evaluate evidence for the effectiveness of SGs on human health, particularly type 2 diabetic (T2D) biomarkers, collecting data from randomized controlled trials (RCTs). Electronic searches were performed in PubMed and EMBASE and the bibliography of retrieved full-texts was hand searched. Using the Cochrane criteria, the reporting quality of included studies was assessed. Seven studies, nine RCTs, including a total of 462 participants were included. A meta-analysis was performed to assess the effect of SGs on following outcomes: BMI, blood pressure (BP), fasting blood glucose (FBG), lipids, and glycated hemoglobin (HbA1c). The meta-analysis revealed an overall significant reduction in systolic BP in favour of SGs between SG and placebo, mean difference (MD): -6.32 mm Hg (-7.69 to 0.46). The overall effect of BMI, diastolic BP, FBG, total cholesterol, and high-density lipoprotein cholesterol (HDL-C) was a non-significant reduction in favour of SGs, and a non-significant increase in low-density lipoprotein cholesterol and triglyceride, while no significant effect of HbA1c was found. Heterogeneity was significant for several analyses. More studies investigating the effect of SGs on human health, particularly T2D biomarkers, are warranted.
Use of Electronic Health Record Data to Study the Association of Sugary Drink Consumption With Child Weight Status. [2021]Sugar-sweetened beverages (SSBs) and, to some extent, fruit juice are modifiable risk factors for childhood obesity. Data on consumption have not been previously systematically collected in the electronic health record (EHR) in a way that could facilitate observational research and population health management.
Overuse of Non-caloric Sweeteners in Foods and Beverages in Chile: A Threat to Consumers' Free Choice? [2020]The prevalence of obesity among Chilean adults and children is one of the highest worldwide. To fight the constant increase of non-communicable diseases and the growing sales of sugar-sweetened beverages, the Chilean government recently enacted a new Law of Food Labeling and Advertising imposing the application of front-of-package warning labels in foodstuffs whose composition exceeds limits for critical nutrients including sugar. Accordingly, food companies have been reformulating their products, incorporating non-caloric sweeteners (NCSs) in partial or total replacement of sucrose. The number of NCS-containing foods and beverages, therefore, has been increasing in the last years. This study aims to identify the NCS-containing products from different food/beverage categories currently available on the Chilean market. Nineteen supermarkets and 13 food web pages were visited by trained dietitians to carry out a systematic search of ingredient information from the different food categories. Overall, 1,489 products were analyzed, of which 815 (55.5%) contained at least one NCS, being this proportion particularly high, compared to other countries. 67.1% of the dairy products, 31.5% of the cereal products, 49% of the processed fruits, 74.3% of the non-alcoholic beverages, and 46.2% of sweets and other desserts contained NCS. Considering the food categories more specifically oriented to children, NCSs were present in 98.8% of powder juices, 98.3% of the flavored milks, 91.2% of jellies, and 79% of the dairy desserts. Sucralose and steviol glycosides were the most widely used NCSs, these sweeteners being present, alone or mixed with other, in 73.5 and 39.7% of the NCS-containing products, respectively, while the use of saccharin and cyclamate was low. In addition, 80 tabletop NCSs were available in the local market, 91.2% of them being sucralose and steviol glycosides (alone or combined). The high number of food products containing steviol glycosides makes very plausible that the daily consumption of this NCS in the pediatric populations could exceed its acceptable daily intake (ADI). The fact that there are no NCS-free foods alternatives for certain food categories, especially for children, is worrying.
Safety of a proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: to expand the list of steviol glycosides to all those identified in the leaves of Stevia Rebaudiana Bertoni. [2020]The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive, in particular to expand the list of steviol glycosides to 60 steviol glycosides identified in the leaves of Stevia Rebaudiana Bertoni. With the existing specifications, the food additive must be comprised of not less than 95% of the 11 named steviol glycosides. The proposed change is to include all 60 steviol glycosides in the same limit value of 95% and this would allow the presence of up to 5% of impurities. FAF Panel considered that all steviol glycosides share the same metabolic fate, and therefore, the safety of 60 identified steviol glycosides can be based on read-across from toxicological data previously evaluated by EFSA and the acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day will apply to all those steviol glycosides. However, according to the proposed change in specifications, there remains a small but not insignificant fraction of the additive that would be undefined and therefore cannot be evaluated by the Panel. The Panel concluded that the inclusion of the 60 steviol glycosides in the proposed specifications for steviol glycoside (E960) would not be of safety concern. However, the Panel cannot conclude on the safety of the proposed amendment to the specifications of steviol glycosides (E 960) as food additive if the purity assay value of not less than 95% for the total content of steviol glycosides is maintained.
Association of Low- and No-Calorie Sweetened Beverages as a Replacement for Sugar-Sweetened Beverages With Body Weight and Cardiometabolic Risk: A Systematic Review and Meta-analysis. [2023]There are concerns that low- and no-calorie sweetened beverages (LNCSBs) do not have established benefits, with major dietary guidelines recommending the use of water and not LNCSBs to replace sugar-sweetened beverages (SSBs). Whether LNCSB as a substitute can yield similar improvements in cardiometabolic risk factors vs water in their intended substitution for SSBs is unclear.