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

December 16, 2025 updated by: Arkansas Children's Hospital Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Nutrition Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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)
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.
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)
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, 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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbial communities
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arkansas Children's Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cargill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva Diaz, M.D., Arkansas Children's Nutrition Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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