Adiposity, Blood Pressure, Insulin Sensitivity, Lipoproteins, Weight Gain
Conditions
Keywords
Cardiometabolic health
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 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
Up to 150 children will be enrolled in the study to achieve a final sample of 90 completers (30 per group). The proposed study will be an 8 to 14-week, three-arm, randomized, controlled, blinded trial in children ages 8 to 12 years from the Central Arkansas region. Children will be randomized to consume one of three beverages: 1) sucrose-sweetened beverage, 2) stevia-sweetened beverage, or 3) calorie-free flavored water beverage. Participants with excessive weight (BMI percentile ≥85th and \<140 percent of the 95th percentile) will complete a 14-week intervention whereas normal-weight (BMI percentile \<85th) participants will complete an 8-week intervention in parallel.
Interventions
OTHERSucrose sweetened beverage
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
OTHERStevia sweetened beverages
Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
OTHERCalorie 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 14 weeks.
Sponsors
Cargill
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
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 (≥2 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 visit) * Asthma that requires daily use of inhalers to keep symptoms under control. * Asthma that requires use of rescue inhalers (e.g., albuterol) \>2 days per week * 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) currently under medication. * Oppositional defiant disorder (ODD). * Epilepsy. * Cancer. * Chronic kidney disease. * Endocrine disorder (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. * If, during the screening or consent process, the parent or child expresses refusal to have blood drawn. However, participants may remain in the study if after initially agreeing to the blood draw and enrolling they change their minds and choose not to allow blood draws or if blood draws are unsuccessful. * Dislike of study products assessed at initial visit. * Fasting glucose ≥126 mg/dl at enrollment. * Fasting A1C ≥6.5% at enrollment * Less than 2 months since completion of antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) z-scores | 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. | 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 | 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. | 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. |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | 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. | HOMA-IR is a unitless estimate of insulin resistance, and it is calculated from fasting glucose and insulin |
| Fasting plasma lipids (Total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol) | 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. | Fasting plasma lipids, mg/dl |
| Blood pressure percentiles | 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. | Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbial communities | Measurements will be obtained at enrollment (baseline) and again at week 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. | Shift in gut microbial communities will be assessed using 16S analyses |
Countries
United States
Contacts
Primary ContactEva C Diaz, M.D.
Backup ContactMario Ferruzzi, Ph.D.
Outcome results
None listed