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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Arkansas Children's Hospital Research Institute
Study ID
NCT05992688
Status
Recruiting
Apply to this trial

Conditions

  • Adiposity
  • Blood Pressure
  • Insulin Sensitivity
  • Lipoproteins
  • Weight Gain

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Sucrose sweetened beverage — OTHER
    Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
  • Stevia sweetened beverages — OTHER
    Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
  • Calorie free flavored water beverage — OTHER
    Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.

Study Details

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 has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.

Key Dates

Start date
Sep 19, 2023
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Sucrose sweetened beverage
    Sucrose (i.e. sugar): 31.2 g sugar (124.8 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.
  • Experimental: Stevia sweetened beverage
    The stevia-sweetened beverage contains 48.6 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.
  • 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.

Primary Outcome Measure

Body mass index (BMI) z-scores [ Time Frame: Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arkansas Children's Nutrition CenterLittle RockArkansas72202
Tonja Nolen
[email protected]
501-364-2853
Eva Diaz, MD
[email protected]
501-364-3056
Arkansas Children's Nutrition CenterLittle RockArkansas72202
Eva C Diaz, MD
[email protected]
501-364-3056
Mario Ferruzzi, PhD
[email protected]
5402314152

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By research site
Arkansas Children's Nutrition Center· Little Rock, AR

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