The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorArkansas Children's Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sucrose sweetened beverage
Other interventionChildren 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
Other interventionChildren 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
Other interventionChildren who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Sucrose sweetened beverageActive comparator 1 intervention
Group B: Stevia sweetened beverageExperimental treatment 1 intervention
Group C: Calorie free flavored water beverageActive comparator 1 intervention
Trial outcomes
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.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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arkansas Children's Hospital Research Institute
Lead sponsor
Cargill
Collaborator
Source ClinicalTrials.gov