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

Arkansas Children's Hospital Research Institute

Status: Enrolling

Conditions: Weight Gain; Adiposity; Blood Pressure; Insulin Sensitivity; Lipoproteins

Treatments: Other: Calorie free flavored water beverage; Other: Stevia sweetened beverages; Other: Sucrose sweetened beverage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05992688

275844

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 (≥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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Sucrose sweetened beverage

Active Comparator group

Description:

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.

Treatment:

Other: Sucrose sweetened beverage

Stevia sweetened beverage

Experimental group

Description:

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.

Treatment:

Other: Stevia sweetened beverages

Calorie free flavored water beverage

Active Comparator group

Description:

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.

Treatment:

Other: Calorie free flavored water beverage