Back to resultsThe Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
Primary Purpose
Weight Gain, Adiposity, Insulin Sensitivity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sucrose sweetened beverage
Stevia sweetened beverages
Calorie free flavored water beverage
Sponsored by
About this trial
This is an interventional prevention trial for Weight Gain focused on measuring Cardiometabolic health
Eligibility Criteria
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
Sites / Locations
- Arkansas Children's Nutrition CenterRecruiting
- Arkansas Children's Nutrition CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Sucrose sweetened beverage
Stevia sweetened beverage
Calorie free flavored water beverage
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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).
Gut microbial communities
Shift in gut microbial communities will be assessed using 16S analyses
Mean of all sensor glucose values
The average of all glucose in mg/dl values measured using continuous glucose monitor
Glycemic variability index
Measured using continuous glucose monitoring and is defined as coefficient of variation of all sensor glucose values (Standard Deviation/mean)
Glucose management index
Measured using continuous glucose monitoring based on the equation: 3.31 + (0.02392 × average glucose in mg/dL)
Fasting plasma triglycerides
Fasting triglycerides measured from fasting plasma (mg/dL)
Blood pressure percentiles
Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.
Full Information
NCT ID
NCT05992688
First Posted
August 8, 2023
Last Updated
September 19, 2023
Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
Cargill
1. Study Identification
Unique Protocol Identification Number
NCT05992688
Brief Title
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
Official Title
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute
Collaborators
Cargill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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:
Sucrose-sweetened beverage
Stevia-sweetened beverage
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Adiposity, Insulin Sensitivity, Microbial Colonization
Keywords
Cardiometabolic health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sucrose sweetened beverage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stevia sweetened beverage
Arm Type
Experimental
Arm Description
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.
Arm Title
Calorie free flavored water beverage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sucrose sweetened beverage
Intervention Description
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
Intervention Type
Other
Intervention Name(s)
Stevia sweetened beverages
Intervention Description
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
Intervention Type
Other
Intervention Name(s)
Calorie free flavored water beverage
Intervention Description
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
Primary Outcome Measure Information:
Title
Body mass index (BMI) z-scores
Description
The change in BMI z-score will be calculated: BMI z-score at completion of the study minus BMI z-score at baseline
Time Frame
8 to 14 weeks
Title
Fat mass index z-scores
Description
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.
Time Frame
8 to 14 weeks
Secondary Outcome Measure Information:
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Description
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).
Time Frame
8 to 14 weeks
Title
Gut microbial communities
Description
Shift in gut microbial communities will be assessed using 16S analyses
Time Frame
8 to 14 weeks
Title
Mean of all sensor glucose values
Description
The average of all glucose in mg/dl values measured using continuous glucose monitor
Time Frame
8 to 14 weeks
Title
Glycemic variability index
Description
Measured using continuous glucose monitoring and is defined as coefficient of variation of all sensor glucose values (Standard Deviation/mean)
Time Frame
8 to 14 weeks
Title
Glucose management index
Description
Measured using continuous glucose monitoring based on the equation: 3.31 + (0.02392 × average glucose in mg/dL)
Time Frame
8 to 14 weeks
Title
Fasting plasma triglycerides
Description
Fasting triglycerides measured from fasting plasma (mg/dL)
Time Frame
8 to 14 weeks
Title
Blood pressure percentiles
Description
Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.
Time Frame
8 to 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva C Diaz, M.D.
Phone
5013643056
Email
ecdiazfuentes@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Ferruzzi, Ph.D.
Phone
5013642781
Email
MFerruzzi@uams.edu
Facility Information:
Facility Name
Arkansas Children's Nutrition Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonja Nolen
Phone
501-364-2853
Email
NolenTC@archildrens.org
First Name & Middle Initial & Last Name & Degree
Eva Diaz, MD
Phone
501-364-3056
Email
ecdiazfuentes@uams.edu
Facility Name
Arkansas Children's Nutrition Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva C Diaz, MD
Phone
501-364-3056
Email
ecdiazfuentes@uams.edu
First Name & Middle Initial & Last Name & Degree
Mario Ferruzzi, PhD
Phone
513642781
Email
MFerruzzi@uams.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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 .
Learn more about this trial
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
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