The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
NCT ID: NCT05992688
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-09-19
2026-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Sucrose sweetened beverage
Sucrose (i.e. sugar): 31.2 g sugar (124.8 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.
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.
Stevia sweetened beverage
The stevia-sweetened beverage contains 48.6 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.
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.
Calorie free flavored water beverage
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
8 Years
12 Years
ALL
Yes
Sponsors
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Cargill
INDUSTRY
Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Eva Diaz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Nutrition Center
Locations
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Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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Tonja Nolen
Role: primary
Eva Diaz, MD
Role: backup
Eva C Diaz, MD
Role: primary
Mario Ferruzzi, PhD
Role: backup
Other Identifiers
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275844
Identifier Type: -
Identifier Source: org_study_id