AdiposityNCT05992688
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
A study testing Sucrose sweetened beverage, Stevia sweetened beverages and Calorie free flavored water beverage in people with Adiposity and Insulin Sensitivity, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Insulin Sensitivity, Weight Gain
- What is being tested?
- Sucrose sweetened beverage, Stevia sweetened beverages and Calorie free flavored water beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 29Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
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.
Read the 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.
- Conditions
- Adiposity, Insulin Sensitivity, Weight Gain, Blood Pressure, Lipoproteins
- Being tested
- Sucrose sweetened beverage, Stevia sweetened beverages, Calorie free flavored water beverage
- Keywords
- Cardiometabolic health
- Medical subject headings
- Obesity, Insulin Resistance, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrose sweetened beverageOther
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 beveragesOther
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 beverageOther
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose sweetened beverage | Active comparator | 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. Receives: Other: Sucrose sweetened beverage |
| Stevia sweetened beverage | Experimental | 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. Receives: Other: Stevia sweetened beverages |
| Calorie free flavored water beverage | Active comparator | 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. Receives: Other: Calorie free flavored water beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Shift in gut microbial communities will be assessed using 16S analyses
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start20 Dec 2023
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Eva Diaz, M.D., Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992688
- Sponsor's protocol ID
- 275844
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 .
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
- ClinicalTrials.gov ID
- NCT05992688
- Acronym / sponsor ID
- 275844
- Conditions
- Adiposity, Insulin Sensitivity, Weight Gain, Blood Pressure, Lipoproteins
- Keywords
- Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sucrose sweetened beverage | Active comparator | Other: Sucrose sweetened beverageSucrose (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 | Experimental | Other: Stevia sweetened beveragesThe 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 comparator | Other: Calorie free flavored water beverageFlavored 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (29 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrose sweetened beverageChildren who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks. | Other | Sucrose sweetened beverage |
| Stevia sweetened beveragesChildren who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks. | Other | Stevia sweetened beverage |
| Calorie free flavored water beverageChildren who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks. | Other | Calorie free flavored water beverage |
Primary outcome
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
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.
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
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
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Diaz, M.D. principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose sweetened beverage, Stevia sweetened beverages and Calorie free flavored water beverage in people with Adiposity and Insulin Sensitivity, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.