Insulin Sensitivity Clinical Trial
Official title:
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | October 31, 2026 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Nutrition Center | Little Rock | Arkansas |
United States | Arkansas Children's Nutrition Center | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute | Cargill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Gut microbial communities | Shift in gut microbial communities will be assessed using 16S analyses | 8 to 14 weeks | |
Secondary | Mean of all sensor glucose values | The average of all glucose in mg/dl values measured using continuous glucose monitor | 8 to 14 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Fasting plasma triglycerides | Fasting triglycerides measured from fasting plasma (mg/dL) | 8 to 14 weeks | |
Secondary | Blood pressure percentiles | Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics. | 8 to 14 weeks |
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