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

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

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.

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

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

Connect with a study center

  • Arkansas Children's Nutrition Center

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

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