Stevia for Childhood Obesity
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Arkansas Children's Hospital Research Institute
Must not be taking: Antibiotics, Inhalers
Disqualifiers: Obesity, Asthma, Autism, Diabetes, others
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have certain medical conditions or are on medications that might affect the study's outcomes, you may not be eligible to participate.
What data supports the effectiveness of the treatment Stevia for Childhood Obesity?
Is stevia safe for human consumption?
Stevia, a low-calorie sweetener, has been affirmed as safe by several food regulatory and safety authorities worldwide. It is generally recognized as safe (GRAS) by the FDA, and the European Food Safety Authority (EFSA) has also evaluated its safety, setting an acceptable daily intake of 4 mg/kg body weight per day. While there are some concerns about impurities, the overall safety of stevia is not considered to be of concern.678910
How does the treatment using stevia-sweetened beverages differ from other treatments for childhood obesity?
The treatment using stevia-sweetened beverages is unique because it offers a plant-based, zero-calorie alternative to sugar, which is significantly sweeter than regular sugar, making it an appealing option for reducing calorie intake in children. Unlike traditional sugar, stevia does not contribute to weight gain and may help manage energy intake, which is crucial in addressing childhood obesity.15101112
Research Team
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
You have a body mass index (BMI) between the 5th and 85th percentile for your age and gender.
You rarely use artificial sweeteners (less than 3 times per week).
My BMI is high, between 35 and less than 40, or it's in the top 15% for my age.
See 3 more
Exclusion Criteria
I have chronic kidney disease.
My child is classified with class 3 obesity.
I have asthma triggered by exercise.
See 17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants consume either a sucrose-sweetened beverage, a stevia-sweetened beverage, or a calorie-free flavored water beverage once a day
8 to 14 weeks
Weekly check-ins (virtual or in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of metabolic function and gut microbial communities
4 weeks
Treatment Details
Interventions
- Calorie free flavored water beverage (Other)
- Stevia sweetened beverages (Other)
- Sucrose sweetened beverage (Other)
Trial OverviewThis 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).
Participant Groups
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.
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 Institute
Lead Sponsor
Trials
141
Patients Recruited
5,025,000+
Cargill
Industry Sponsor
Trials
28
Patients Recruited
3,200+
Findings from Research
Low-calorie sweeteners (LCSs) are commonly found in beverages, with 32% of adult and 19% of child beverage consumption in the U.S. containing them, but there is limited evidence on their long-term effects on health.
While LCS beverages may help adults reduce sugar-sweetened beverage intake and manage weight, prolonged consumption by children is not recommended due to potential adverse effects, and water remains the best beverage choice.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association.Johnson, RK., Lichtenstein, AH., Anderson, CAM., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.Katan, MB., de Ruyter, JC., Kuijper, LD., et al.[2018]
Substituting low- and no-calorie sweetened beverages (LNCSBs) for sugar-sweetened beverages (SSBs) was associated with a small but significant reduction in body weight and improvements in cardiometabolic risk factors, based on a systematic review of 17 randomized clinical trials involving 1733 adults.
In contrast, substituting water for SSBs did not show any significant benefits, suggesting that LNCSBs can be a viable alternative for reducing body weight and improving health outcomes in adults with overweight or obesity, particularly those at risk for diabetes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.McGlynn, ND., Khan, TA., Wang, L., et al.[2023]
In a study involving 89 children aged 5 to 12, only 24% could distinguish between non-nutritively sweetened and sugar-sweetened beverages, indicating that many children may not notice a difference in taste.
The children showed no preference between non-nutritively sweetened and sugar-sweetened beverages, both scoring similarly on a liking scale, suggesting that non-nutritively sweetened drinks could be a viable alternative to reduce sugar intake.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Can children discriminate sugar-sweetened from non-nutritively sweetened beverages and how do they like them?de Ruyter, JC., Katan, MB., Kas, R., et al.[2019]
In Chile, over half (55.5%) of the analyzed food products contained non-caloric sweeteners (NCSs), with particularly high prevalence in dairy (67.1%) and non-alcoholic beverages (74.3%), indicating a significant shift in product formulation due to new food labeling laws.
The widespread use of NCSs, especially sucralose and steviol glycosides, raises concerns about children's consumption potentially exceeding the acceptable daily intake, as many products targeted at children contain these sweeteners, and there are few NCS-free alternatives available.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Overuse of Non-caloric Sweeteners in Foods and Beverages in Chile: A Threat to Consumers' Free Choice?Sambra, V., López-Arana, S., Cáceres, P., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Biological fate of low-calorie sweeteners.Magnuson, BA., Carakostas, MC., Moore, NH., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The safety and regulatory process for low calorie sweeteners in the United States.Roberts, A.[2018]
The EFSA Panel concluded that expanding the specifications for steviol glycosides (E 960) to include 60 identified glycosides is not a safety concern, as they share similar metabolic pathways and can be evaluated based on existing toxicological data.
The acceptable daily intake (ADI) of 4 mg/kg body weight per day applies to all steviol glycosides, but the Panel noted that the presence of up to 5% impurities in the additive could not be fully evaluated, leaving some uncertainty regarding safety if purity is not maintained.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.Younes, M., Aquilina, G., Engel, KH., et al.[2020]
Female Sprague-Dawley rats and C57BL/6J mice showed a strong preference for a high-rebaudioside, low-stevioside extract from stevia, comparable to saccharin, but with less tendency to overdrink, indicating a favorable response to stevia sweeteners.
Mice preferred pure rebaudioside A and a commercial mixture of rebaudioside A and erythritol (Truvia) over other noncaloric sweeteners, suggesting that the sweet taste of stevia is appealing to rodents, unlike some other sweeteners like aspartame.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Stevia and saccharin preferences in rats and mice.Sclafani, A., Bahrani, M., Zukerman, S., et al.[2022]
Steviol glycoside sweeteners from the Stevia plant are gaining popularity as low- and no-calorie sweeteners due to their plant-based origin, zero calories, and sweetness that is 50-350 times greater than sugar, making them suitable for reducing sugar intake in food and beverages.
Despite being affirmed as safe by various food regulatory authorities, there is still a lack of education about stevia's safety and benefits, which affects its acceptance among health professionals and consumers.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Stevia Leaf to Stevia Sweetener: Exploring Its Science, Benefits, and Future Potential.Samuel, P., Ayoob, KT., Magnuson, BA., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effect of Steviol Glycosides on Human Health with Emphasis on Type 2 Diabetic Biomarkers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Bundgaard Anker, CC., Rafiq, S., Jeppesen, PB.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Stevia rebaudiana Bertoni extract supplementation improves lipid and carnitine profiles in C57BL/6J mice fed a high-fat diet.Park, JE., Cha, YS.[2015]
References
Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association. [2019]
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]
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]
Can children discriminate sugar-sweetened from non-nutritively sweetened beverages and how do they like them? [2019]
Overuse of Non-caloric Sweeteners in Foods and Beverages in Chile: A Threat to Consumers' Free Choice? [2020]
Biological fate of low-calorie sweeteners. [2018]
The safety and regulatory process for low calorie sweeteners in the United States. [2018]
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]
Stevia and saccharin preferences in rats and mice. [2022]
Stevia Leaf to Stevia Sweetener: Exploring Its Science, Benefits, and Future Potential. [2023]
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]
Stevia rebaudiana Bertoni extract supplementation improves lipid and carnitine profiles in C57BL/6J mice fed a high-fat diet. [2015]