Evaluating the effects of stevia on weight and metabolic health in children
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
This study is testing whether drinks sweetened with stevia can help children aged 8 to 12 with excess weight manage their weight and improve their metabolic health compared to regular sugary drinks and flavored water.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Locations | 2 sites (Little Rock, Arkansas and 1 other locations) |
| Trial ID | NCT05992688 on ClinicalTrials.gov |
What this trial studies
This study is a randomized controlled trial involving children aged 8 to 12 years, conducted over 8 to 14 weeks. Participants will be assigned to consume either a sucrose-sweetened beverage, a stevia-sweetened beverage, or calorie-free flavored water. The primary aim is to assess the impact of these beverages on weight control and metabolic function, particularly in children with excessive weight. Additionally, the study will monitor safety indicators related to steviol consumption and changes in gut microbial communities.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 12 years with either normal weight or excessive weight who regularly consume sugar-sweetened beverages.
Not a fit: Children with class 3 obesity, severe asthma, autism spectrum disorders, ADHD, ODD, epilepsy, or chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective dietary interventions for weight management and metabolic health in children.
How similar studies have performed: Previous studies have shown promising results regarding the use of non-caloric sweeteners like stevia for weight management, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age 8-12 years * Normal weight: BMI percentile ≥5th to \<85th * Excessive weight: BMI percentile ≥ 85th and \<140% of the 95th percentile or BMI ≥35 to \<40 kg/m2 * Current consumption of sugar sweetened beverages (≥2 times /wk) * Low consumption of non-nutritive sweeteners (≤ 3 time/wk) * Willingness to consume experimental products Exclusion Criteria * Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg/m2) * Dislike of experimental beverage taste (assessed at initial visit) * Asthma that requires daily use of inhalers to keep symptoms under control. * Asthma that requires use of rescue inhalers (e.g., albuterol) \>2 days per week * Exercise induced asthma. * Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS). * Attention deficit hyperactivity disorder (ADHD) currently under medication. * Oppositional defiant disorder (ODD). * Epilepsy. * Cancer. * Chronic kidney disease. * Endocrine disorder (e.g., hypothyroidism and growth hormone deficiency). * Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis) * Bleeding disorders (e.g., hemophilia) * Chronic infections (e.g., HIV, hepatitis B, hepatitis C). * Mental health disorders (e.g., depression and anxiety). * Type 2 and type 1 diabetes mellitus. * Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest. * If, during the screening or consent process, the parent or child expresses refusal to have blood drawn. However, participants may remain in the study if after initially agreeing to the blood draw and enrolling they change their minds and choose not to allow blood draws or if blood draws are unsuccessful. * Dislike of study products assessed at initial visit. * Fasting glucose ≥126 mg/dl at enrollment. * Fasting A1C ≥6.5% at enrollment * Less than 2 months since completion of antibiotics
Where this trial is running
Little Rock, Arkansas and 1 other locations
- Arkansas Children's Nutrition Center — Little Rock, Arkansas, United States (Recruiting)
- Arkansas Children's Nutrition Center — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Eva Diaz, M.D. — Arkansas Children's Nutrition Center
- Study coordinator: Eva C Diaz, M.D.
- Email: ecdiazfuentes@uams.edu
- Phone: 5013643056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.