The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
- Conditions
- Weight GainAdiposityInsulin SensitivityMicrobial Colonization
- Interventions
- Other: Sucrose sweetened beverageOther: Stevia sweetened beveragesOther: Calorie free flavored water beverage
- Registration Number
- NCT05992688
- Lead Sponsor
- Arkansas Children's Hospital Research Institute
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sucrose sweetened beverage Sucrose sweetened beverage Sucrose (i.e. sugar): 25 g sugar (100 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 Stevia sweetened beverages The stevia-sweetened beverage contains 30.1 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 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.
- Primary Outcome Measures
Name Time Method Fat mass index z-scores 8 to 14 weeks 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.
Body mass index (BMI) z-scores 8 to 14 weeks The change in BMI z-score will be calculated: BMI z-score at completion of the study minus BMI z-score at baseline
- Secondary Outcome Measures
Name Time Method Fasting plasma triglycerides 8 to 14 weeks Fasting triglycerides measured from fasting plasma (mg/dL)
Blood pressure percentiles 8 to 14 weeks Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) 8 to 14 weeks HOMA-IR is a unitless estimate of insulin resistance, and it is calculated from fasting glucose (nmol/L) and fasting insulin (microU/L) or C-peptide (nmol/L).
Gut microbial communities 8 to 14 weeks Shift in gut microbial communities will be assessed using 16S analyses
Mean of all sensor glucose values 8 to 14 weeks The average of all glucose in mg/dl values measured using continuous glucose monitor
Glycemic variability index 8 to 14 weeks Measured using continuous glucose monitoring and is defined as coefficient of variation of all sensor glucose values (Standard Deviation/mean)
Glucose management index 8 to 14 weeks Measured using continuous glucose monitoring based on the equation: 3.31 + (0.02392 × average glucose in mg/dL)
Trial Locations
- Locations (1)
Arkansas Children's Nutrition Center
🇺🇸Little Rock, Arkansas, United States