The Sweet Kids Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Sucrose-sweetened beverage
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Stevia-sweetened beverage
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Other: Sucrose sweetened beverage
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
|
| Experimental: Stevia sweetened beverage 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
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
|
| Active Comparator: 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. |
Other: Calorie free flavored water beverage
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- BMI z-scores [8 to 14 weeks]
Change in BMI z-scores
- Fat mass index z-scores [8 to 14 weeks]
Change in fat mass index z-scores measured using DXA
Secondary Outcome Measures
- Cardiometabolic health status [8 to 14 weeks]
A comprehensive composite score will be used to assess cardiometabolic health status of children
- Gut microbial communities [8 to 14 weeks]
Shift in gut microbial communities will be assessed using 16S analyses
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 8-12 years
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Normal weight: BMI percentile ≥5th to <85th
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Excessive weight: BMI percentile ≥ 85th and <140% of the 95th percentile or BMI ≥35 to <40 kg/m2
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Current consumption of sugar sweetened beverages (≥3 times /wk)
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Low consumption of non-nutritive sweeteners (≤ 3 time/wk)
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Willingness to consume experimental products
Exclusion Criteria:
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Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg/m2)
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Dislike of experimental beverage taste (assessed at initial screening)
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Severe persistent asthma (determined by daily use of inhaler(s) to keep asthma symptoms under control).
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Exercise induced asthma.
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Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
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Attention deficit hyperactivity disorder (ADHD).
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Oppositional defiant disorder (ODD).
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Epilepsy.
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Chronic kidney disease.
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Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).
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Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)
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Bleeding disorders (e.g., hemophilia)
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Chronic infections (e.g., HIV, hepatitis B, hepatitis C).
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Mental health disorders (e.g., depression and anxiety).
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Type 2 and type 1 diabetes mellitus.
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Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
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Parent/child refusal to have blood drawn.
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Fasting glucose ≥126 mg/dl at enrollment.
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Fasting A1C ≥6.5% at enrollment or follow up visits.
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Less than 2 months since completion of antibiotics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Children's Nutrition Center | Little Rock | Arkansas | United States | 72202 |
Sponsors and Collaborators
- Arkansas Children's Hospital Research Institute
- Cargill
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 275844