Recruiting

Stevia

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT05992688

Conditions

Adiposity

Insulin Sensitivity

Weight Gain

Blood Pressure

Lipoproteins

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Interventions

Sucrose sweetened beverage

Stevia sweetened beverages

Calorie free flavored water beverage

Study Details

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.

Conditions

Adiposity

Insulin Sensitivity

Weight Gain

Blood Pressure

Lipoproteins

Study ID

NCT05992688

Start date

Sep 19, 2023

Status verified date

Dec, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

Primary outcome measure

  • Body mass index (BMI) z-scores [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Eva C Diaz, M.D.

5013643056ecdiazfuentes@uams.edu

Mario Ferruzzi, Ph.D.

5013642781MFerruzzi@uams.edu

Locations

Arkansas Children's Nutrition Center

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Tonja Nolen

501-364-2853NolenTC@archildrens.org

Eva Diaz, MD

501-364-3056ecdiazfuentes@uams.edu

Arkansas Children's Nutrition Center

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Eva C Diaz, MD

501-364-3056ecdiazfuentes@uams.edu

Mario Ferruzzi, PhD

5402314152mferruzzi@vt.edu

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • Cardiometabolic health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2025-12-22.