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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992688
• Other study ID #: 275844
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: August 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: Eva C Diaz, M.D.
• Phone: 5013643056
• Email: ecdiazfuentes[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Body Weight
• Communicable Diseases
• Infections
• Insulin Resistance
• Insulin Sensitivity
• Microbial Colonization
• Weight Gain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	Cargill

Country where clinical trial is conducted

United States, 

Outcome

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