NCT05992688 The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
| NCT ID | NCT05992688 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arkansas Children's Hospital Research Institute |
| Condition | Adiposity |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-09-19 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.
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 (≥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
Contact & Investigator
Eva Diaz, M.D.
PRINCIPAL INVESTIGATOR
Arkansas Children's Nutrition Center
Frequently Asked Questions
Who can join the NCT05992688 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Adiposity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05992688 currently recruiting?
Yes, NCT05992688 is actively recruiting participants. Contact the research team at ecdiazfuentes@uams.edu for enrollment information.
Where is the NCT05992688 trial being conducted?
This trial is being conducted at Little Rock, United States, Little Rock, United States.
Who is sponsoring the NCT05992688 clinical trial?
NCT05992688 is sponsored by Arkansas Children's Hospital Research Institute. The principal investigator is Eva Diaz, M.D. at Arkansas Children's Nutrition Center. The trial plans to enroll 150 participants.