Clinical trial NCT05992688: The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
Official title: The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Gain
Adiposity
Insulin Sensitivity
Microbial Colonization
Keywords: Cardiometabolic health
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2023-08-15
Enrollment: 210
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (as with other sweeteners and consistent with prior research in children and adults) 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: The proposed study will be an 8 to14-week three-arm randomized controlled blinded trial in children ages 8 to12 years from the Central, Arkansas region. Children with normal weight (BMI percentile \<85th, n = 90) and excessive weight (BMI percentile ≥85th and \<140% of the 95th, n =120) will consume either:

1. Sucrose-sweetened beverage
2. Stevia-sweetened beverage
3. Calorie free flavored water beverage Participants with excessive weight will complete a 14-week intervention to assess both primary and secondary hypotheses. In parallel, normal weight participants will be enrolled with the objective of monitoring indicators of safety for steviol consumption through assessment of changes in metabolic function (glucoregulation and cardiometabolic) markers as well as assessment of shifts in gut microbial communities and steviol metabolism over 8 weeks

Eligibility criteria: 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 (≥3 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 screening)
* Severe persistent asthma (determined by daily use of inhaler(s) to keep asthma symptoms under control).
* 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).
* Oppositional defiant disorder (ODD).
* Epilepsy.
* Chronic kidney disease.
* Hormonal disease (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.
* Parent/child refusal to have blood drawn.
* Fasting glucose ≥126 mg/dl at enrollment.
* Fasting A1C ≥6.5% at enrollment or follow up visits.
* Less than 2 months since completion of antibiotics

Primary outcomes:
measure: Body mass index (BMI) z-scores
timeFrame: 8 to 14 weeks
measure: Fat mass index z-scores
timeFrame: 8 to 14 weeks
Secondary outcomes:
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: 8 to 14 weeks
measure: Gut microbial communities
timeFrame: 8 to 14 weeks
measure: Mean of all sensor glucose values
timeFrame: 8 to 14 weeks
measure: Glycemic variability index
timeFrame: 8 to 14 weeks
measure: Glucose management index
timeFrame: 8 to 14 weeks
measure: Fasting plasma triglycerides
timeFrame: 8 to 14 weeks
measure: Blood pressure percentiles
timeFrame: 8 to 14 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References: