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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Weight Gain; Adiposity; Insulin Sensitivity; Lipoproteins
• Intervention / Treatment: Other: Sucrose sweetened beverage; Other: Stevia sweetened beverages; Other: Calorie free flavored water beverage

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva C Diaz, M.D.; Phone Number: 5013643056; Email: ecdiazfuentes@uams.edu
• Study Contact Backup: Name: Mario Ferruzzi, Ph.D.; Phone Number: 5013642781; Email: MFerruzzi@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Children's Nutrition Center
      • Contact: Eva C Diaz, MD; Phone Number: 501-364-3056; Email: ecdiazfuentes@uams.edu
      • Contact: Mario Ferruzzi, PhD; Phone Number: 5402314152; Email: mferruzzi@vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbial communities	Shift in gut microbial communities will be assessed using 16S analyses	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.

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: Cargill
• Investigators: Principal Investigator: Eva Diaz, M.D., Arkansas Children's Nutrition Center

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiometabolic health
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Insulin Resistance; Weight Gain
• Other Study ID Numbers: 275844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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 .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No