NCT05992688

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

Up to 150 children will be enrolled in the study to achieve a final sample of 90 completers (30 per group). The proposed study will be an 8 to 14-week, three-arm, randomized, controlled, blinded trial in children ages 8 to 12 years from the Central Arkansas region. Children will be randomized to consume one of three beverages: 1) sucrose-sweetened beverage, 2) stevia-sweetened beverage, or 3) calorie-free flavored water beverage. Participants with excessive weight (BMI percentile ≥85th and \<140 percent of the 95th percentile) will complete a 14-week intervention whereas normal-weight (BMI percentile \<85th) participants will complete an 8-week intervention in parallel.

Conditions

• Adiposity
• Insulin Sensitivity
• Weight Gain
• Blood Pressure
• Lipoproteins

Interventions

Type	Name	Description
OTHER	Sucrose sweetened beverage	Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
OTHER	Stevia sweetened beverages	Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
OTHER	Calorie free flavored water beverage	Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.

Timeline

• Start date: 2023-09-19
• Primary completion: 2026-05-31
• Completion: 2026-11-30
• First posted: 2023-08-15
• Last updated: 2025-12-22

Locations

2 sites across 1 country: United States