Last updated: September 19, 2023
Sponsor: Arkansas Children's Hospital Research Institute
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Prevention
Hormone Deficiencies
Obesity
Treatment
Stevia sweetened beverages
Sucrose sweetened beverage
Calorie free flavored water beverage
Clinical Study ID
NCT05992688
275844
Ages 8-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0kg/m2)
- Dislike of experimental beverage taste (assessed at initial screening)
- Severe persistent asthma (determined by daily use of inhaler(s) to keep asthmasymptoms under control).
- Exercise induced asthma.
- Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder,childhood disintegrative disorder, pervasive developmental disorder not otherwisespecified (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 theinvestigators 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
Total Participants: 210
Treatment Group(s): 3
Primary Treatment: Stevia sweetened beverages
Phase:
Study Start date:
September 19, 2023
Estimated Completion Date:
October 31, 2026
Study Description
Connect with a study center
Arkansas Children's Nutrition Center
Little Rock, Arkansas 72202
United StatesActive - Recruiting
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