ClinicalTrials.gg
CompletedNCT05992688Updated Oct 15, 2026

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

An interventional study of Sucrose sweetened beverage and Stevia sweetened beverages in Adiposity, Insulin Sensitivity and Weight Gain, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Prevention

Updated Oct 15, 2026Now CompletedStart date moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Obesity by Arkansas Children's Hospital Research Institute — 3 open to participants now, 5 under way, none of them phase 3. Obesity · Arkansas Children's Hospital Research Institute.

Started
2023
the only one that year
No phase
9 of 12
3 open now
Registered
8th of 12
by date

Among the 12 studies in Obesity by Arkansas Children's Hospital Research Institute, this one is the only one that started in 2023, is one of 9 with no phase, and was the 8th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phasethis study9 · 3 open
Observational3 · 0 open

By the year they started

First in 2012; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 106 across the 9 interventional studies, 82 across the 3 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Obesity by Arkansas Children's Hospital Research Institute, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Adiposity
  • Insulin Sensitivity
  • Weight Gain
  • Blood Pressure
  • Lipoproteins

Keywords

  • Cardiometabolic health
04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria

  • Age 8-12 years
  • Normal weight: 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).
  • diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)
  • Bleeding disorders (e.g., hemophilia)
  • Chronic infections (e.g., , , ).
  • 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 ≥6.5% at enrollment
  • Less than 2 months since completion of antibiotics
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
106 participants (actual)

Study 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.

    Other: Sucrose sweetened beverage

  • 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

  • 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

Interventions

  • OtherSucrose 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.

  • OtherStevia 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.

  • OtherCalorie 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.

06

What researchers measure

Primary outcomes

  1. 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

    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.

  2. 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.

    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.

  3. 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

    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.

  4. Fasting plasma lipids (Total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol)

    Fasting plasma lipids, mg/dl

    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.

  5. Blood pressure percentiles

    Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.

    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.

Secondary outcomes

  1. Gut microbial communities

    Shift in gut microbial communities will be assessed using 16S analyses

    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.

07

Study locations

1 site
  • Arkansas Children's Nutrition Center
    Little Rock, Arkansas 72202, United States
08

References and documents

Individual participant data

Plan to share: 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 .

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2023 to primary completion in Mar 2026, 27 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 27 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: start Sep 2023 → Dec 2023, primary completion May 2026 → Mar 2026 and completion Nov 2026 → Mar 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2023
First posted
Aug 15, 2023
StartActual
Dec 20, 2023was Sep 2023
Primary completionActual
Mar 23, 2026was May 2026
CompletionActual
Mar 23, 2026was Nov 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 15, 2026
Sites
1 site removed
Show 1 removed
  • Arkansas Children's Nutrition Center · Little Rock, United States
Oct 15, 2026
Start date
Sep 19, 2023→Dec 20, 2023
Oct 15, 2026
Primary completion
May 31, 2026→Mar 23, 2026 (actual)
Oct 15, 2026
Study completion
Nov 30, 2026→Mar 23, 2026 (actual)
Oct 15, 2026
Enrollment
150 (estimated)→106 (actual)
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Recruiting→Completed
    1 site removed
    Show 1 removed
    • Arkansas Children's Nutrition Center · Little Rock, United States
    Start date Sep 19, 2023→Dec 20, 2023
    Primary completion May 31, 2026→Mar 23, 2026 (now actual)
    Study completion Nov 30, 2026→Mar 23, 2026 (now actual)
    Enrollment 150 (estimated)→106 (actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05992688
Collaborators
Cargill
Responsible party
Sponsor
First posted
Aug 15, 2023
Start date
Dec 20, 2023
Primary completion
Mar 23, 2026
Completion
Mar 23, 2026
Last update
Oct 15, 2026

Study contacts

Eva Diaz, M.D.
principal investigator · Arkansas Children's Nutrition Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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