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.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization; Weight Gain; Adiposity; Insulin Sensitivity
• Intervention / Treatment: Other: Sucrose sweetened beverage; Other: Stevia sweetened beverages; Other: Calorie free flavored water beverage

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:

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

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva C Diaz, M.D.; Phone Number: 5013643056; Email: ecdiazfuentes@uams.edu
• Study Contact Backup: Name: Mario Ferruzzi, Ph.D.; Phone Number: 5013642781; Email: MFerruzzi@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Children's Nutrition Center
      • Contact: Eva C Diaz, MD; Phone Number: 501-364-3056; Email: ecdiazfuentes@uams.edu
      • Contact: Mario Ferruzzi, PhD; Phone Number: 513642781; Email: MFerruzzi@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbial communities	Shift in gut microbial communities will be assessed using 16S analyses	8 to 14 weeks
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
Mean of all sensor glucose values	The average of all glucose in mg/dl values measured using continuous glucose monitor	8 to 14 weeks
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
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
Fasting plasma triglycerides	Fasting triglycerides measured from fasting plasma (mg/dL)	8 to 14 weeks
Blood pressure percentiles	Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.	8 to 14 weeks

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: Cargill

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cardiometabolic health
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperinsulinism; Body Weight Changes; Infections; Communicable Diseases; Insulin Resistance; Body Weight; Weight Gain
• Other Study ID Numbers: 275844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All study subject materials will be assigned a unique identifying code or number. The key to the code will be kept in a shared network folder with access granted only to study staff who have had appropriate CITI training. Only study investigators/staff will have access to the code and information that identifies the subject in this study. Coded data for all primary and secondary outcomes as well as secondary data analysis will be shared with the Sponsor (Cargill Corporation) using an approved shared folder .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No