The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)

Launched by ARKANSAS CHILDREN'S HOSPITAL RESEARCH INSTITUTE · Aug 8, 2023

Keywords

ClinConnect Summary

The Sweet Kids Study is a clinical trial aimed at understanding whether stevia, a natural sweetener, can help control weight and improve metabolic health in children aged 8 to 12. The study compares the effects of stevia with regular sugary drinks and water over a period of 8 to 14 weeks. Researchers want to see if using stevia instead of sugar can help kids maintain a healthy weight and support better health outcomes.

To participate, children should have a normal weight or be slightly overweight but not extremely so. They should also be drinking sugary beverages regularly but not using non-nutritive sweeteners often. Unfortunately, children with certain health conditions, like severe asthma or diabetes, or those taking specific medications, cannot join the study. Participants will be asked to try new beverages during the trial and will have their health monitored regularly. This study could be a great opportunity for kids who are looking to manage their weight while enjoying sweet flavors in a healthier way.

Gender

ALL

Eligibility 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 (≥3 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 screening)
• • Severe persistent asthma (determined by daily use of inhaler(s) to keep asthma symptoms under control).
• • 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).
• • Oppositional defiant disorder (ODD).
• • Epilepsy.
• • Chronic kidney disease.
• • Hormonal disease (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.
• • Parent/child refusal to have blood drawn.
• • Fasting glucose ≥126 mg/dl at enrollment.
• • Fasting A1C ≥6.5% at enrollment or follow up visits.
• • Less than 2 months since completion of antibiotics