The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedStudy Start
First participant enrolled
September 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
December 22, 2025
December 1, 2025
2.7 years
August 8, 2023
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Body mass index (BMI) z-scores
The change in BMI z-score will be calculated: BMI z-score at completion of the study minus BMI z-score at baseline
Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Fat mass index z-scores
The change in fat mass index (FMI) z-score will be calculated: FMI z-score at completion of the study minus FMI z-score at baseline.
Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR is a unitless estimate of insulin resistance, and it is calculated from fasting glucose and insulin
Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Fasting plasma lipids (Total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol)
Fasting plasma lipids, mg/dl
Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Blood pressure percentiles
Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.
Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Secondary Outcomes (1)
Gut microbial communities
Measurements will be obtained at enrollment (baseline) and again at week 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Study Arms (3)
Sucrose sweetened beverage
ACTIVE COMPARATORSucrose (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.
Stevia sweetened beverage
EXPERIMENTALThe 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.
Calorie free flavored water beverage
ACTIVE COMPARATORFlavored 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.
Interventions
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
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
You may qualify if:
- 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)
You may not qualify if:
- 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).
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arkansas Children's Hospital Research Institutelead
- Cargillcollaborator
Study Sites (2)
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202, United States
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Diaz, M.D.
Arkansas Children's Nutrition Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2023
First Posted
August 15, 2023
Study Start
September 19, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
All study subject materials will be assigned a unique identifying code or number. The key to the code will be kept in a shared network folder with access granted only to study staff who have had appropriate CITI training. Only study investigators/staff will have access to the code and information that identifies the subject in this study. Coded data for all primary and secondary outcomes as well as secondary data analysis will be shared with the Sponsor (Cargill Corporation) using an approved shared folder .