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

Study Overview
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Brief Summary
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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
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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: Sucrose-sweetened beverage Stevia-sweetened beverage 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

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

Conditions
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Weight Gain, Adiposity, Insulin Sensitivity, Microbial Colonization

Intervention / Treatment
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* Other: Sucrose sweetened beverage
* Other: Stevia sweetened beverages
* Other: Calorie free flavored water beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sucrose sweetened beverage<br>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. | Other: Sucrose sweetened beverage<br>* Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.<br>|
| Experimental: Stevia sweetened beverage<br>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. | Other: Stevia sweetened beverages<br>* Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.<br>|
| Active Comparator: Calorie free flavored water beverage<br>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<br>* Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 to 14 weeks | 
| 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. | 8 to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | 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). | 8 to 14 weeks | 
| Gut microbial communities | Shift in gut microbial communities will be assessed using 16S analyses | 8 to 14 weeks | 
| Mean of all sensor glucose values | The average of all glucose in mg/dl values measured using continuous glucose monitor | 8 to 14 weeks | 
| Glycemic variability index | Measured using continuous glucose monitoring and is defined as coefficient of variation of all sensor glucose values (Standard Deviation/mean) | 8 to 14 weeks | 
| Glucose management index | Measured using continuous glucose monitoring based on the equation: 3.31 + (0.02392 × average glucose in mg/dL) | 8 to 14 weeks | 
| Fasting plasma triglycerides | Fasting triglycerides measured from fasting plasma (mg/dL) | 8 to 14 weeks | 
| Blood pressure percentiles | Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics. | 8 to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiometabolic health